Velocity Clinical Research is an owned and integrated research site organization, providing excellence in patient care, high quality data and fully integrated research sites. At Velocity, we align our values and behaviors to give our employees the best chance of delivering on our brand promise to bring innovative medical treatments to patients. We are committed to making clinical trials succeed by generating high quality data from as many patients as possible, as quickly as possible while providing exemplary patient care at every step. As an employee of Velocity, you are the most integral part of our mission. For talented candidates who perform at a high level, Velocity will invest to support career advancement and reward performance. Whether you are new to clinical research or are an industry veteran, we invite you to apply to Velocity. As a key member of our AI team, you will own the end-to-end AI/ML pipelines and be instrumental in integrating Generative AI (GenAI) technologies. You will work with technical product managers, chief data architect, and business users to build and productionize AI and LLM-based models that support data-driven decision-making and smart automation. You will leverage tools such as GitHub Copilot, Cursor, WindSurf, and modern GenAI frameworks to deliver intelligent, scalable solutions. Engineer and manage end-to-end data and AI/GenAI pipelines, including data extraction, cleansing, transformation, training, and model deployment Perform data analysis, LLM prompt design, and fine-tuning Integrate and productionize LLM-based solutions and support RAG pipelines for scalable inference Conduct and iterate on LLM evaluations (Evals) for model accuracy, relevance, and reliability Develop advanced dashboards and visualizations for operational and strategic insights Use dev tools such as GitHub Copilot, Cursor, WindSurf, and others to enhance development productivity Design and implement model monitoring and feedback loop mechanisms to continuously improve system performance and reliability Stay current with the latest in Generative AI, data science, and machine learning to evaluate and apply innovations to projects Education B.Tech in Computer Science or a related field Advanced diploma in Data Science, Machine Learning, or related area Experience 3+ years of experience building and deploying AI/ML models 3+ years of experience in building scalable data pipelines 3+ years in developing advanced visualizations that deliver impactful insights Experience working with LLM APIs (e.g., OpenAI, Hugging Face) Preferred Skills Strong grasp of AI/ML and GenAI techniques including prompt engineering, RAG (Retrieval-Augmented Generation), and LLM evaluations (Evals) Understanding of vector databases and embedding models Familiarity with cloud-native development (AWS, GCP, Azure) Strong understanding of databases, data lakes, and data warehouses Proficiency with development tools such as GitHub Copilot, WindSurf, Cursor, Replit, and related platforms NOTE The above Job Description is intended to communicate the general function of the mentioned position and by no means should be considered an exhaustive or complete outline of the specific tasks and functions that will be required. Additionally, specific tasks and duties of the position are subject to change as the Company, the department and circumstances change. All employees are expected to perform their duties within their ability as required by the job and/or as requested by management
As a member of Velocity Clinical Research, you play a crucial role in our commitment to delivering innovative medical treatments to patients. We value excellence in patient care, high-quality data, and fully integrated research sites. By aligning our values and behaviors, we provide our employees with the support they need to uphold our brand promise. At Velocity, we prioritize the success of clinical trials by generating high-quality data from a wide range of patients while ensuring exceptional patient care at every stage. We believe that talented individuals, whether new to clinical research or seasoned veterans, have the opportunity to excel within our organization. Joining our team comes with a range of benefits including medical, dental, and vision insurance, paid time off, company holidays, a 401(k) retirement plan with company-match, and an annual incentive program. The role of an L2 Support Engineer at Velocity involves monitoring, analyzing, and troubleshooting daily issues to ensure seamless operations. Responsibilities include logging, tracking, and managing Incidents and Service Requests, as well as utilizing Incident logging and Bug tracking tools to document customer incidents efficiently. L2 Support Engineers are expected to resolve issues by researching documentation, troubleshooting hardware and software, guiding clients through corrective steps, and escalating problems when necessary. Additionally, they document and track all received requests in the incident management system, schedule onsite technicians for hardware repairs, and identify priority tickets to meet key performance indicators. Key skills for this role include excellent communication, experience in documented processes and workflows, maintaining a Runbook for immediate resolutions, and utilizing knowledge bases for solutions. L2 Support Engineers should be proficient in handling break/fix configuration issues, guiding customers on troubleshooting, and assisting with software installations and repairs. Candidates for this position should have a Bachelor's degree in Management Information Systems, Computer Science, IT, or an equivalent field. Please note that the Job Description provided is a general overview of the position's function and is subject to change as per the Company's needs and evolving circumstances. All employees are expected to fulfill their duties to the best of their abilities and as requested by management.,
As a Principal Generative AI (GenAI) Engineer at Velocity Clinical Research, you play a crucial role in developing and implementing advanced Generative AI solutions to drive innovation and create business value. Your responsibilities include designing, optimizing, and deploying cutting-edge AI models and techniques such as Large Language Models (LLMs) and Retrieval-Augmented Generation (RAG). Working closely with cross-functional teams, you will integrate these technologies into products and services to ensure they meet performance and business requirements. Your deep understanding of AI and continuous awareness of the latest advancements will be vital in shaping the future of AI capabilities at Velocity. Your duties involve actively designing, developing, and deploying advanced Generative AI applications using techniques like prompt engineering and RAG. Collaborating with data scientists, ML engineers, and product teams, you will translate business requirements into scalable GenAI applications. You will experiment with new Generative AI techniques, evaluate models rigorously, and explore agentic frameworks to develop AI systems capable of autonomous decision-making. Staying updated with Generative AI research, you will optimize models for real-world deployment, integrate them into production environments, and contribute to best practices specific to Generative AI technologies. To excel in this role, you must possess a deep understanding of machine learning algorithms, neural networks, and natural language processing. Expertise in working with Generative AI models, prompt engineering, and RAG techniques is essential. Proficiency in programming languages like Python, TensorFlow, and PyTorch, as well as experience with data pre-processing, ethical considerations in AI model development, and software engineering skills are required. You should be able to build, deploy, and maintain scalable AI/ML pipelines, work with APIs and microservices architecture, and demonstrate strong problem-solving skills and a passion for innovation in AI. Ideally, you hold a Bachelor's or Master's degree in Computer Science, Artificial Intelligence, or a related field, with a Ph.D. preferred. With at least 8 years of software engineering experience, including 4+ years focused on AI/ML, and a background in Generative AI technologies, you should also have experience with LLMs like GPT and BERT. Effective communication skills, mentorship abilities, and a proven track record of developing production-level AI/ML solutions are essential for success in this role. Please note that this Job Description provides a general overview of the position's function and is not an exhaustive list of specific tasks. Job duties are subject to change based on Company and departmental needs. All employees are expected to perform their duties to the best of their abilities and as requested by management.,
Overview: Job Summary: This position is responsible for configuring, managing, and supporting clinical research teams in data entry and validation, and ensuring adherence to regulatory and sponsor requirements. The EDC Coordinator will work closely with the site staff to optimize electronic data workflows and maintain data integrity. Responsibilities: Duties/Responsibilities: Support clinical research site staff with accurate data entry, query resolution, and validation checks to ensure data quality. Ensure data management processes adhere to Good Clinical Practice (GCP), FDA, and sponsor-specific regulations. Monitor data discrepancies, perform data cleaning activities Work closely with clinical research teams, sponsors, and IT teams to optimize data collection, reporting, and security. Identify and resolve EDC system issues, escalating as necessary to vendors or IT teams. Other duties as assigned Qualifications: Required Skills/Abilities: Strong understanding of clinical trial data collection, GCP guidelines, and regulatory requirements. Excellent analytical skills and attention to detail to ensure data accuracy and compliance. Ability to work independently and collaboratively in a fast-paced clinical research setting. Education and Experience: Highschool Diploma required, Bachelor's degree or Technical Degree in life sciences, healthcare, or related field preferred. Strong attention to detail, organizational skills, and ability to follow protocols. Familiarity with research regulations (GCP, IRB, FDA) is a plus. Experience: 1-2 years of experience in clinical research, healthcare, or laboratory settings. NOTE: The above Job Description is intended to communicate the general function of the mentioned position and by no means should be considered an exhaustive or complete outline of the specific tasks and functions that will be required. Additionally, specific tasks and duties of the position are subject to change as the Company, the department and circumstances change. All employees are expected to perform their duties within their ability as required by the job and/or as requested by management.
Overview: Job Summary: This position is responsible for configuring, managing, and supporting clinical research teams in data entry and validation, and ensuring adherence to regulatory and sponsor requirements. The EDC Coordinator will work closely with the site staff to optimize electronic data workflows and maintain data integrity. Responsibilities: Duties/Responsibilities: Support clinical research site staff with accurate data entry, query resolution, and validation checks to ensure data quality. Ensure data management processes adhere to Good Clinical Practice (GCP), FDA, and sponsor-specific regulations. Monitor data discrepancies, perform data cleaning activities Work closely with clinical research teams, sponsors, and IT teams to optimize data collection, reporting, and security. Identify and resolve EDC system issues, escalating as necessary to vendors or IT teams. Other duties as assigned Qualifications: Required Skills/Abilities: Strong understanding of clinical trial data collection, GCP guidelines, and regulatory requirements. Excellent analytical skills and attention to detail to ensure data accuracy and compliance. Ability to work independently and collaboratively in a fast-paced clinical research setting. Education and Experience: Highschool Diploma required, Bachelor's degree or Technical Degree in life sciences, healthcare, or related field preferred. Strong attention to detail, organizational skills, and ability to follow protocols. Familiarity with research regulations (GCP, IRB, FDA) is a plus. Experience: 1-2 years of experience in clinical research, healthcare, or laboratory settings. NOTE: The above Job Description is intended to communicate the general function of the mentioned position and by no means should be considered an exhaustive or complete outline of the specific tasks and functions that will be required. Additionally, specific tasks and duties of the position are subject to change as the Company, the department and circumstances change. All employees are expected to perform their duties within their ability as required by the job and/or as requested by management.
Job Summary This position is responsible for configuring, managing, and supporting clinical research teams in data entry and validation, and ensuring adherence to regulatory and sponsor requirements. The EDC Coordinator will work closely with the site staff to optimize electronic data workflows and maintain data integrity. Duties/Responsibilities Support clinical research site staff with accurate data entry, query resolution, and validation checks to ensure data quality. Ensure data management processes adhere to Good Clinical Practice (GCP), FDA, and sponsor-specific regulations. Monitor data discrepancies, perform data cleaning activities Work closely with clinical research teams, sponsors, and IT teams to optimize data collection, reporting, and security. Identify and resolve EDC system issues, escalating as necessary to vendors or IT teams. Other duties as assigned Required Skills/Abilities Strong understanding of clinical trial data collection, GCP guidelines, and regulatory requirements. Excellent analytical skills and attention to detail to ensure data accuracy and compliance. Ability to work independently and collaboratively in a fast-paced clinical research setting. Education and Experience Highschool Diploma required, Bachelor's degree or Technical Degree in life sciences, healthcare, or related field preferred. Strong attention to detail, organizational skills, and ability to follow protocols. Familiarity with research regulations (GCP, IRB, FDA) is a plus. Experience 1-2 years of experience in clinical research, healthcare, or laboratory settings. NOTE The above Job Description is intended to communicate the general function of the mentioned position and by no means should be considered an exhaustive or complete outline of the specific tasks and functions that will be required. Additionally, specific tasks and duties of the position are subject to change as the Company, the department and circumstances change. All employees are expected to perform their duties within their ability as required by the job and/or as requested by management.
Job Summary This position is responsible for configuring, managing, and supporting clinical research teams in data entry and validation, and ensuring adherence to regulatory and sponsor requirements. The EDC Coordinator will work closely with the site staff to optimize electronic data workflows and maintain data integrity. Duties/Responsibilities Support clinical research site staff with accurate data entry, query resolution, and validation checks to ensure data quality. Ensure data management processes adhere to Good Clinical Practice (GCP), FDA, and sponsor-specific regulations. Monitor data discrepancies, perform data cleaning activities Work closely with clinical research teams, sponsors, and IT teams to optimize data collection, reporting, and security. Identify and resolve EDC system issues, escalating as necessary to vendors or IT teams. Other duties as assigned Required Skills/Abilities Strong understanding of clinical trial data collection, GCP guidelines, and regulatory requirements. Excellent analytical skills and attention to detail to ensure data accuracy and compliance. Ability to work independently and collaboratively in a fast-paced clinical research setting. Education and Experience Highschool Diploma required, Bachelor's degree or Technical Degree in life sciences, healthcare, or related field preferred. Strong attention to detail, organizational skills, and ability to follow protocols. Familiarity with research regulations (GCP, IRB, FDA) is a plus. Experience 1-2 years of experience in clinical research, healthcare, or laboratory settings. NOTE The above Job Description is intended to communicate the general function of the mentioned position and by no means should be considered an exhaustive or complete outline of the specific tasks and functions that will be required. Additionally, specific tasks and duties of the position are subject to change as the Company, the department and circumstances change. All employees are expected to perform their duties within their ability as required by the job and/or as requested by management.
Job Summary This position is responsible for configuring, managing, and supporting clinical research teams in data entry and validation, and ensuring adherence to regulatory and sponsor requirements. The EDC Coordinator will work closely with the site staff to optimize electronic data workflows and maintain data integrity. Duties/Responsibilities Support clinical research site staff with accurate data entry, query resolution, and validation checks to ensure data quality. Ensure data management processes adhere to Good Clinical Practice (GCP), FDA, and sponsor-specific regulations. Monitor data discrepancies, perform data cleaning activities Work closely with clinical research teams, sponsors, and IT teams to optimize data collection, reporting, and security. Identify and resolve EDC system issues, escalating as necessary to vendors or IT teams. Other duties as assigned Required Skills/Abilities Strong understanding of clinical trial data collection, GCP guidelines, and regulatory requirements. Excellent analytical skills and attention to detail to ensure data accuracy and compliance. Ability to work independently and collaboratively in a fast-paced clinical research setting. Education and Experience Highschool Diploma required, Bachelor's degree or Technical Degree in life sciences, healthcare, or related field preferred. Strong attention to detail, organizational skills, and ability to follow protocols. Familiarity with research regulations (GCP, IRB, FDA) is a plus. Experience 1-2 years of experience in clinical research, healthcare, or laboratory settings. NOTE The above Job Description is intended to communicate the general function of the mentioned position and by no means should be considered an exhaustive or complete outline of the specific tasks and functions that will be required. Additionally, specific tasks and duties of the position are subject to change as the Company, the department and circumstances change. All employees are expected to perform their duties within their ability as required by the job and/or as requested by management.
Job Summary This position is responsible for configuring, managing, and supporting clinical research teams in data entry and validation, and ensuring adherence to regulatory and sponsor requirements. The EDC Coordinator will work closely with the site staff to optimize electronic data workflows and maintain data integrity. Duties/Responsibilities Support clinical research site staff with accurate data entry, query resolution, and validation checks to ensure data quality. Ensure data management processes adhere to Good Clinical Practice (GCP), FDA, and sponsor-specific regulations. Monitor data discrepancies, perform data cleaning activities Work closely with clinical research teams, sponsors, and IT teams to optimize data collection, reporting, and security. Identify and resolve EDC system issues, escalating as necessary to vendors or IT teams. Other duties as assigned Required Skills/Abilities Strong understanding of clinical trial data collection, GCP guidelines, and regulatory requirements. Excellent analytical skills and attention to detail to ensure data accuracy and compliance. Ability to work independently and collaboratively in a fast-paced clinical research setting. Education and Experience Highschool Diploma required, Bachelor's degree or Technical Degree in life sciences, healthcare, or related field preferred. Strong attention to detail, organizational skills, and ability to follow protocols. Familiarity with research regulations (GCP, IRB, FDA) is a plus. Experience 1-2 years of experience in clinical research, healthcare, or laboratory settings. NOTE The above Job Description is intended to communicate the general function of the mentioned position and by no means should be considered an exhaustive or complete outline of the specific tasks and functions that will be required. Additionally, specific tasks and duties of the position are subject to change as the Company, the department and circumstances change. All employees are expected to perform their duties within their ability as required by the job and/or as requested by management.
Job Summary This position is responsible for configuring, managing, and supporting clinical research teams in data entry and validation, and ensuring adherence to regulatory and sponsor requirements. The EDC Coordinator will work closely with the site staff to optimize electronic data workflows and maintain data integrity. Duties/Responsibilities Support clinical research site staff with accurate data entry, query resolution, and validation checks to ensure data quality. Ensure data management processes adhere to Good Clinical Practice (GCP), FDA, and sponsor-specific regulations. Monitor data discrepancies, perform data cleaning activities Work closely with clinical research teams, sponsors, and IT teams to optimize data collection, reporting, and security. Identify and resolve EDC system issues, escalating as necessary to vendors or IT teams. Other duties as assigned Required Skills/Abilities Strong understanding of clinical trial data collection, GCP guidelines, and regulatory requirements. Excellent analytical skills and attention to detail to ensure data accuracy and compliance. Ability to work independently and collaboratively in a fast-paced clinical research setting. Education and Experience Highschool Diploma required, Bachelor's degree or Technical Degree in life sciences, healthcare, or related field preferred. Strong attention to detail, organizational skills, and ability to follow protocols. Familiarity with research regulations (GCP, IRB, FDA) is a plus. Experience 1-2 years of experience in clinical research, healthcare, or laboratory settings. NOTE The above Job Description is intended to communicate the general function of the mentioned position and by no means should be considered an exhaustive or complete outline of the specific tasks and functions that will be required. Additionally, specific tasks and duties of the position are subject to change as the Company, the department and circumstances change. All employees are expected to perform their duties within their ability as required by the job and/or as requested by management.
Job Summary This position is responsible for configuring, managing, and supporting clinical research teams in data entry and validation, and ensuring adherence to regulatory and sponsor requirements. The EDC Coordinator will work closely with the site staff to optimize electronic data workflows and maintain data integrity. Duties/Responsibilities Support clinical research site staff with accurate data entry, query resolution, and validation checks to ensure data quality. Ensure data management processes adhere to Good Clinical Practice (GCP), FDA, and sponsor-specific regulations. Monitor data discrepancies, perform data cleaning activities Work closely with clinical research teams, sponsors, and IT teams to optimize data collection, reporting, and security. Identify and resolve EDC system issues, escalating as necessary to vendors or IT teams. Other duties as assigned Required Skills/Abilities Strong understanding of clinical trial data collection, GCP guidelines, and regulatory requirements. Excellent analytical skills and attention to detail to ensure data accuracy and compliance. Ability to work independently and collaboratively in a fast-paced clinical research setting. Education and Experience Highschool Diploma required, Bachelor's degree or Technical Degree in life sciences, healthcare, or related field preferred. Strong attention to detail, organizational skills, and ability to follow protocols. Familiarity with research regulations (GCP, IRB, FDA) is a plus. Experience 1-2 years of experience in clinical research, healthcare, or laboratory settings. NOTE The above Job Description is intended to communicate the general function of the mentioned position and by no means should be considered an exhaustive or complete outline of the specific tasks and functions that will be required. Additionally, specific tasks and duties of the position are subject to change as the Company, the department and circumstances change. All employees are expected to perform their duties within their ability as required by the job and/or as requested by management.
Job Summary This position is responsible for configuring, managing, and supporting clinical research teams in data entry and validation, and ensuring adherence to regulatory and sponsor requirements. The EDC Coordinator will work closely with the site staff to optimize electronic data workflows and maintain data integrity. Duties/Responsibilities Support clinical research site staff with accurate data entry, query resolution, and validation checks to ensure data quality. Ensure data management processes adhere to Good Clinical Practice (GCP), FDA, and sponsor-specific regulations. Monitor data discrepancies, perform data cleaning activities Work closely with clinical research teams, sponsors, and IT teams to optimize data collection, reporting, and security. Identify and resolve EDC system issues, escalating as necessary to vendors or IT teams. Other duties as assigned Required Skills/Abilities Strong understanding of clinical trial data collection, GCP guidelines, and regulatory requirements. Excellent analytical skills and attention to detail to ensure data accuracy and compliance. Ability to work independently and collaboratively in a fast-paced clinical research setting. Education and Experience Highschool Diploma required, Bachelor's degree or Technical Degree in life sciences, healthcare, or related field preferred. Strong attention to detail, organizational skills, and ability to follow protocols. Familiarity with research regulations (GCP, IRB, FDA) is a plus. Experience 1-2 years of experience in clinical research, healthcare, or laboratory settings. NOTE The above Job Description is intended to communicate the general function of the mentioned position and by no means should be considered an exhaustive or complete outline of the specific tasks and functions that will be required. Additionally, specific tasks and duties of the position are subject to change as the Company, the department and circumstances change. All employees are expected to perform their duties within their ability as required by the job and/or as requested by management.
Job Summary This position is responsible for configuring, managing, and supporting clinical research teams in data entry and validation, and ensuring adherence to regulatory and sponsor requirements. The EDC Coordinator will work closely with the site staff to optimize electronic data workflows and maintain data integrity. Duties/Responsibilities Support clinical research site staff with accurate data entry, query resolution, and validation checks to ensure data quality. Ensure data management processes adhere to Good Clinical Practice (GCP), FDA, and sponsor-specific regulations. Monitor data discrepancies, perform data cleaning activities Work closely with clinical research teams, sponsors, and IT teams to optimize data collection, reporting, and security. Identify and resolve EDC system issues, escalating as necessary to vendors or IT teams. Other duties as assigned Required Skills/Abilities Strong understanding of clinical trial data collection, GCP guidelines, and regulatory requirements. Excellent analytical skills and attention to detail to ensure data accuracy and compliance. Ability to work independently and collaboratively in a fast-paced clinical research setting. Education and Experience Highschool Diploma required, Bachelor's degree or Technical Degree in life sciences, healthcare, or related field preferred. Strong attention to detail, organizational skills, and ability to follow protocols. Familiarity with research regulations (GCP, IRB, FDA) is a plus. Experience 1-2 years of experience in clinical research, healthcare, or laboratory settings. NOTE The above Job Description is intended to communicate the general function of the mentioned position and by no means should be considered an exhaustive or complete outline of the specific tasks and functions that will be required. Additionally, specific tasks and duties of the position are subject to change as the Company, the department and circumstances change. All employees are expected to perform their duties within their ability as required by the job and/or as requested by management.
Job Summary This position is responsible for configuring, managing, and supporting clinical research teams in data entry and validation, and ensuring adherence to regulatory and sponsor requirements. The EDC Coordinator will work closely with the site staff to optimize electronic data workflows and maintain data integrity. Duties/Responsibilities Support clinical research site staff with accurate data entry, query resolution, and validation checks to ensure data quality. Ensure data management processes adhere to Good Clinical Practice (GCP), FDA, and sponsor-specific regulations. Monitor data discrepancies, perform data cleaning activities Work closely with clinical research teams, sponsors, and IT teams to optimize data collection, reporting, and security. Identify and resolve EDC system issues, escalating as necessary to vendors or IT teams. Other duties as assigned Required Skills/Abilities Strong understanding of clinical trial data collection, GCP guidelines, and regulatory requirements. Excellent analytical skills and attention to detail to ensure data accuracy and compliance. Ability to work independently and collaboratively in a fast-paced clinical research setting. Education and Experience Highschool Diploma required, Bachelor's degree or Technical Degree in life sciences, healthcare, or related field preferred. Strong attention to detail, organizational skills, and ability to follow protocols. Familiarity with research regulations (GCP, IRB, FDA) is a plus. Experience 1-2 years of experience in clinical research, healthcare, or laboratory settings. NOTE The above Job Description is intended to communicate the general function of the mentioned position and by no means should be considered an exhaustive or complete outline of the specific tasks and functions that will be required. Additionally, specific tasks and duties of the position are subject to change as the Company, the department and circumstances change. All employees are expected to perform their duties within their ability as required by the job and/or as requested by management.
As a Manager at Velocity Clinical Research, you will play a crucial role in study start-up activities, focusing on regulatory compliance, source document delivery, and ensuring timely submission of key documents to facilitate study initiation. Your responsibilities will include managing a team of regulatory specialists, proactively addressing regulatory challenges, driving efficiency, and ensuring that regulatory submissions are completed promptly to avoid delays in study start-up. You will be involved in preparing study-specific protocol documents, informed consent forms, HIPAA authorizations, and other necessary materials for review by the Institutional Review Board (IRB). Additionally, you may be responsible for submitting protocol amendments, annual requests for continuing protocol approval, adverse event reports, and other IRB-required documentation. Your role will also involve guiding staff members on completing conflict of interest paperwork and maintaining the study binder with all IRB-related documents. As a proactive and innovative leader, you will work towards breaking down barriers, meeting corporate objectives, and identifying potential gaps in study start-up processes to ensure smooth operations. Your ability to think out of the box, provide mentorship, and develop regular progress reports for executive management will be crucial in achieving study start-up milestones. You will collaborate with auditors, maintain electronic regulatory files, coordinate meetings, ensure compliance with regulatory trends, and uphold safety and compliance regulations. Moreover, your attention to detail, problem-solving skills, and adherence to regulatory requirements such as ICH, GCP, and FDA guidelines will be essential in maintaining binder accuracy, completeness, and inspection readiness. In addition to technical proficiency in using computers, Microsoft Office software, and other relevant technologies, you are expected to possess advanced verbal and written communication skills, organizational abilities, and a strong aptitude for working in a fast-paced environment. Your capacity to mentor, train, and lead a team, along with a minimum of four to six years of clinical research regulatory experience and previous supervisory experience, will be advantageous in excelling in this role. Please note that this job description serves to outline the general functions of the position and may not encompass all specific tasks and duties required. Tasks and responsibilities are subject to change based on company needs and circumstances. All employees are expected to perform their duties to the best of their abilities as required by the job and management's requests.,
As an integral part of Velocity Clinical Research's mission, you will play a crucial role in preparing and maintaining accurate source material to facilitate the setup and delivery of clinical research studies. Your commitment to ensuring high-quality data and timely study start-up will contribute significantly to the success of clinical trials and the advancement of innovative medical treatments. Your dedication to exemplary patient care and adherence to safety and compliance regulations will be paramount in achieving our goals. Your responsibilities will include supporting the review, creation, and setup of study documentation to expedite study start-up, ensuring the timely completion of source documents, and maintaining data source integrity through a multi-step procedure. You will collaborate with site-level teams, assist in the acquisition process for new sites, and communicate effectively with internal and external stakeholders regarding source status and changes. To excel in this role, you must possess a demonstrated knowledge of medical terminology, proficiency in using various technologies including Microsoft Office software, strong verbal and written communication skills, and the ability to work both independently and as part of a team. Your attention to detail, flexibility in adapting to changing priorities, and understanding of regulatory requirements such as ICH, GCP, and FDA guidelines will be essential. To qualify for this position, you should hold a Bachelor's degree with relevant experience in the life science industry, an Associate degree with industry experience, or a High School Graduate/technical degree with significant industry experience. Additionally, you should be able to meet the physical requirements of prolonged desk work, communication by phone and in person, and occasional lifting of up to 30 pounds. Please note that while this job description outlines the general functions of the position, specific tasks and duties may evolve as per the Company's needs and circumstances. Your professionalism, proactive approach to tasks, and willingness to adapt to changing requirements will be key to your success in this role at Velocity Clinical Research.,
Velocity Clinical Research is an owned and integrated research site organization, providing excellence in patient care, high quality data and fully integrated research sites. At Velocity, we align our values and behaviors to give our employees the best chance of delivering on our brand promise to bring innovative medical treatments to patients. We are committed to making clinical trials succeed by generating high quality data from as many patients as possible, as quickly as possible while providing exemplary patient care at every step. As an employee of Velocity, you are the most integral part of our mission. For talented candidates who perform at a high level, Velocity will invest to support career advancement and reward performance. Whether you are new to clinical research or are an industry veteran, we invite you to apply to Velocity. Benefits include medical, dental and vision insurance, paid time off and company holidays, 401(k) retirement plan with company-match, and an annual incentive program. Summary The Regualtory Specialist I prepares and maintains complete and accurate regulatory documents in support of clinical research studies. Role & Responsibilities Prepare each study specific protocol, informed consent form, HIPAA authorization and other related documents for review by the IRB. Supports initial regulatory submission documents for IRB and sponsors to ensure site meets regulatory readiness metrics with a focus on expedited study start up Ensures regulatory submissions are done in a timely manner as to not delay study start up Prepare and submit amendments, yearly requests for continuing approval of open protocols, audits, deviations, adverse event reports, and any other IRB-required submissions. Work with staff members to complete Financial Disclosure Forms for each study. Assist new hires in completing and submitting all required research documentation and trainings by their deadlines. Assist coordinators and site leadership in tracking the training status for existing staff, assisting with updates as needed. Assist coordinators in ensuring that all staff on the delegation of authority logs have the appropriate training on file. Maintain study binder, paper or electronic as appropriate, with all IRB related documents and correspondence for each study to ensure audit readiness at all times. Notify staff and Site Manager/Director of upcoming training expiration dates Assist site leadership and coordinators in the preparation for monitoring visits, sponsor audits, and regulatory audits by conducting quality checks of the regulatory binder. Assist with the preparation and submission of closeout documents to the sponsors and IRBs including ensuring completeness, audit-readiness and closure of the regulatory binder and appropriate archival of trial data. Supports maintenance oof DOA logs and any other required logs as needed Submit or support SAE and AE submissions to the IRB as needed and in a timely fashion Supports audit and inspection readiness by ensuring accurate and timely file completion. Provide copies of IRB documents to sponsors, as needed. Adhere to safety and compliance regulations. Other duties as assigned Education/Experience Bachelor’s degree with 1 year of relevant experience in the life science industry OR Associate’s degree with 2 years of relevant experience in the life science industry OR High School Graduate and/or technical degree with minimum of 3 years relevant experience in the life science industry Required Licenses/Certifications None Required Skills Demonstrated knowledge of medical terminology Demonstrated ability to use the following technology Computers, Microsoft Office software, fax, copier, and multi-line telephone. Demonstrated verbal, written, and organizational skills Demonstrated interpersonal and communication skills Demonstrated ability to work as a team player Demonstrated ability to read, write, and speak English Demonstrated ability to multi-task Demonstrated ability to follow written guidelines Demonstrated ability to work independently, plan and prioritize with some guidance Demonstrated ability to be flexible/adapt according to the needs of the clinic priortization Must be detail oriented Proficient ability to accept individual responsibility for actions taken and demonstrate professionalism when judged, critiqued and/or praised Demonstrated understanding of ICH, GCP, and FDA regulatory requirements Required Physical Abilites Sit or stand for long periods of time Travel locally and nationally Communicate in person and by a telephone Limited walking required Limited to lifting up to 30 pounds NOTE The above Job Description is intended to communicate the general function of the mentioned position and by no means should be considered an exhaustive or complete outline of the specific tasks and functions that will be required. Additionally, specific tasks and duties of the position are subject to change as the Company, the department and circumstances change. All employees are expected to perform their duties within their ability as required by the job and/or as requested by management.
Velocity Clinical Research is an owned and integrated research site organization, providing excellence in patient care, high quality data and fully integrated research sites. At Velocity, we align our values and behaviors to give our employees the best chance of delivering on our brand promise to bring innovative medical treatments to patients. We are committed to making clinical trials succeed by generating high quality data from as many patients as possible, as quickly as possible while providing exemplary patient care at every step. As an employee of Velocity, you are the most integral part of our mission. For talented candidates who perform at a high level, Velocity will invest to support career advancement and reward performance. Whether you are new to clinical research or are an industry veteran, we invite you to apply to Velocity. Benefits include medical, dental and vision insurance, paid time off and company holidays, 401(k) retirement plan with company-match, and an annual incentive program. Summary The Regualtory Specialist I prepares and maintains complete and accurate regulatory documents in support of clinical research studies. Role & Responsibilities Prepare each study specific protocol, informed consent form, HIPAA authorization and other related documents for review by the IRB. Supports initial regulatory submission documents for IRB and sponsors to ensure site meets regulatory readiness metrics with a focus on expedited study start up Ensures regulatory submissions are done in a timely manner as to not delay study start up Prepare and submit amendments, yearly requests for continuing approval of open protocols, audits, deviations, adverse event reports, and any other IRB-required submissions. Work with staff members to complete Financial Disclosure Forms for each study. Assist new hires in completing and submitting all required research documentation and trainings by their deadlines. Assist coordinators and site leadership in tracking the training status for existing staff, assisting with updates as needed. Assist coordinators in ensuring that all staff on the delegation of authority logs have the appropriate training on file. Maintain study binder, paper or electronic as appropriate, with all IRB related documents and correspondence for each study to ensure audit readiness at all times. Notify staff and Site Manager/Director of upcoming training expiration dates Assist site leadership and coordinators in the preparation for monitoring visits, sponsor audits, and regulatory audits by conducting quality checks of the regulatory binder. Assist with the preparation and submission of closeout documents to the sponsors and IRBs including ensuring completeness, audit-readiness and closure of the regulatory binder and appropriate archival of trial data. Supports maintenance oof DOA logs and any other required logs as needed Submit or support SAE and AE submissions to the IRB as needed and in a timely fashion Supports audit and inspection readiness by ensuring accurate and timely file completion. Provide copies of IRB documents to sponsors, as needed. Adhere to safety and compliance regulations. Other duties as assigned Education/Experience Bachelor’s degree with 1 year of relevant experience in the life science industry OR Associate’s degree with 2 years of relevant experience in the life science industry OR High School Graduate and/or technical degree with minimum of 3 years relevant experience in the life science industry Required Licenses/Certifications None Required Skills Demonstrated knowledge of medical terminology Demonstrated ability to use the following technology Computers, Microsoft Office software, fax, copier, and multi-line telephone. Demonstrated verbal, written, and organizational skills Demonstrated interpersonal and communication skills Demonstrated ability to work as a team player Demonstrated ability to read, write, and speak English Demonstrated ability to multi-task Demonstrated ability to follow written guidelines Demonstrated ability to work independently, plan and prioritize with some guidance Demonstrated ability to be flexible/adapt according to the needs of the clinic priortization Must be detail oriented Proficient ability to accept individual responsibility for actions taken and demonstrate professionalism when judged, critiqued and/or praised Demonstrated understanding of ICH, GCP, and FDA regulatory requirements Required Physical Abilites Sit or stand for long periods of time Travel locally and nationally Communicate in person and by a telephone Limited walking required Limited to lifting up to 30 pounds NOTE The above Job Description is intended to communicate the general function of the mentioned position and by no means should be considered an exhaustive or complete outline of the specific tasks and functions that will be required. Additionally, specific tasks and duties of the position are subject to change as the Company, the department and circumstances change. All employees are expected to perform their duties within their ability as required by the job and/or as requested by management.
Velocity Clinical Research is an owned and integrated research site organization, providing excellence in patient care, high quality data and fully integrated research sites. At Velocity, we align our values and behaviors to give our employees the best chance of delivering on our brand promise to bring innovative medical treatments to patients. We are committed to making clinical trials succeed by generating high quality data from as many patients as possible, as quickly as possible while providing exemplary patient care at every step. As an employee of Velocity, you are the most integral part of our mission. For talented candidates who perform at a high level, Velocity will invest to support career advancement and reward performance. Whether you are new to clinical research or are an industry veteran, we invite you to apply to Velocity. Benefits include medical, dental and vision insurance, paid time off and company holidays, 401(k) retirement plan with company-match, and an annual incentive program. Summary The Regualtory Specialist I prepares and maintains complete and accurate regulatory documents in support of clinical research studies. Role & Responsibilities Prepare each study specific protocol, informed consent form, HIPAA authorization and other related documents for review by the IRB. Supports initial regulatory submission documents for IRB and sponsors to ensure site meets regulatory readiness metrics with a focus on expedited study start up Ensures regulatory submissions are done in a timely manner as to not delay study start up Prepare and submit amendments, yearly requests for continuing approval of open protocols, audits, deviations, adverse event reports, and any other IRB-required submissions. Work with staff members to complete Financial Disclosure Forms for each study. Assist new hires in completing and submitting all required research documentation and trainings by their deadlines. Assist coordinators and site leadership in tracking the training status for existing staff, assisting with updates as needed. Assist coordinators in ensuring that all staff on the delegation of authority logs have the appropriate training on file. Maintain study binder, paper or electronic as appropriate, with all IRB related documents and correspondence for each study to ensure audit readiness at all times. Notify staff and Site Manager/Director of upcoming training expiration dates Assist site leadership and coordinators in the preparation for monitoring visits, sponsor audits, and regulatory audits by conducting quality checks of the regulatory binder. Assist with the preparation and submission of closeout documents to the sponsors and IRBs including ensuring completeness, audit-readiness and closure of the regulatory binder and appropriate archival of trial data. Supports maintenance oof DOA logs and any other required logs as needed Submit or support SAE and AE submissions to the IRB as needed and in a timely fashion Supports audit and inspection readiness by ensuring accurate and timely file completion. Provide copies of IRB documents to sponsors, as needed. Adhere to safety and compliance regulations. Other duties as assigned Education/Experience Bachelor’s degree with 1 year of relevant experience in the life science industry OR Associate’s degree with 2 years of relevant experience in the life science industry OR High School Graduate and/or technical degree with minimum of 3 years relevant experience in the life science industry Required Licenses/Certifications None Required Skills Demonstrated knowledge of medical terminology Demonstrated ability to use the following technology Computers, Microsoft Office software, fax, copier, and multi-line telephone. Demonstrated verbal, written, and organizational skills Demonstrated interpersonal and communication skills Demonstrated ability to work as a team player Demonstrated ability to read, write, and speak English Demonstrated ability to multi-task Demonstrated ability to follow written guidelines Demonstrated ability to work independently, plan and prioritize with some guidance Demonstrated ability to be flexible/adapt according to the needs of the clinic priortization Must be detail oriented Proficient ability to accept individual responsibility for actions taken and demonstrate professionalism when judged, critiqued and/or praised Demonstrated understanding of ICH, GCP, and FDA regulatory requirements Required Physical Abilites Sit or stand for long periods of time Travel locally and nationally Communicate in person and by a telephone Limited walking required Limited to lifting up to 30 pounds NOTE The above Job Description is intended to communicate the general function of the mentioned position and by no means should be considered an exhaustive or complete outline of the specific tasks and functions that will be required. Additionally, specific tasks and duties of the position are subject to change as the Company, the department and circumstances change. All employees are expected to perform their duties within their ability as required by the job and/or as requested by management.
Velocity Clinical Research is an owned and integrated research site organization, providing excellence in patient care, high quality data and fully integrated research sites. At Velocity, we align our values and behaviors to give our employees the best chance of delivering on our brand promise to bring innovative medical treatments to patients. We are committed to making clinical trials succeed by generating high quality data from as many patients as possible, as quickly as possible while providing exemplary patient care at every step. As an employee of Velocity, you are the most integral part of our mission. For talented candidates who perform at a high level, Velocity will invest to support career advancement and reward performance. Whether you are new to clinical research or are an industry veteran, we invite you to apply to Velocity. Benefits include medical, dental and vision insurance, paid time off and company holidays, 401(k) retirement plan with company-match, and an annual incentive program. Summary The Senior Regulatory Specialist is the subject matter expert and leader of a regulatory team to prepare and maintain complete and accurate regulatory documents in support of clinical research studies. Role & Responsibilities Leads a team of multiple regulatory specialists supporting one or more Velocity Clinical Research sites Ensures regulatory submissions are done in a timely manner as to not delay study start up. Prepare each study specific protocol, informed consent form, HIPAA authorization and other related documents for review by the IRB. Prepare and submit amendments, yearly requests for continuing approval of open protocols, audits, adverse event reports, and any other IRB-required submissions. Work with staff members to complete conflict of interest paperwork for each study. Assist new hires in completing and submitting all required research documentation and trainings. Track training status for existing staff, assisting with updates as needed. Maintain study binder with all IRB related documents and correspondence for each study. Maintain electronic regulatory files, including tracking document history. Maintain a database of staff listings and training dates. Pro-actively notify staff and Site Manager/Director of upcoming training expiration dates to maintain compliance Coordinate meetings with auditors to review paper and electronic regulatory files and inspectors. Provide copies of IRB documents to sponsors, as needed. Adhere to safety and compliance regulations. Stay abreast of evolving regulatory trends and work with the Site Manager/Site Director to ensure compliance with changes in the regulations Ensures binder accuracy, completeness and inspection readiness Prepare local IRB submissions Review ICFs for completeness - ensure the California Bill of Rights is included as applicable, subject stipends are accurate, and all protocol procedures are captured in the ICF Ensures that ICFs and other study documents are available in any language as required by the site and approved by the IRB Works with the Velocity IRB of record to submit generic site material Other duties as assigned Education/Experience Bachelor’s degree and 4 years of clinical research regulatory experience OR Associate’s degree with 6 years of clinical research regulatory experience OR High School Graduate and/or technical degree with minimum of 8 years of clinical research regulatory experience Required Licenses/Certifications None Certified Clinical Research Professional a plus Required Skills Proficient in the use of the following technology Computers, Microsoft Office software, fax, copier, and multi-line telephone. Proficient ability to work in a fast paced environment Advanced verbal, written, and organizational skills Advanced interpersonal and communication skills Advanced ability to work as a team player Advanced ability to read, write, and speak English Demonstrated ability to multi-task Demonstrated ability to mentor and train Advanced ability to follow written guidelines Proficient ability to work independently, plan and prioritize with minimal guidance Proficient ability to be flexible/adapt according to the needs of the clinic priortization Must be detailed oriented and can demonstrate attention to detail Proficient problem solving and strategic decision making ability. Advanced in accepting individual responsibility for actions taken and demonstrating professionalism when judged, critiqued and/or praised Proficient leader, mentor an team builder Advanced understanding of ICH, GCP, and FDA regulatory requirements Required Physical Abilities Sit or stand for long periods of time Travel locally and nationally Communicate in person and by a telephone Limited walking required Limited to lifting up to 30 pounds NOTE The above Job Description is intended to communicate the general function of the mentioned position and by no means should be considered an exhaustive or complete outline of the specific tasks and functions that will be required. Additionally, specific tasks and duties of the position are subject to change as the Company, the department and circumstances change. All employees are expected to perform their duties within their ability as required by the job and/or as requested by management.