Job Title: Medical Writer Company : MS Clinical Location : Bangalore Job Type : Full-time Experience: 2-4 years About MS Clinical : MS Clinical is a dynamic and innovative company dedicated to advancing medical research and improving patient outcomes. We specialize in conducting clinical trials and providing comprehensive medical writing services to pharmaceutical, biotechnology, and healthcare organizations worldwide. Job Description : We are seeking an experienced Medical Writer to join our vibrant team. The successful candidate will be responsible for creating high-quality, scientifically accurate medical documents in support of our clinical trial activities and regulatory submissions. The ideal candidate will have a strong background in medical writing, excellent communication skills, and the ability to work both independently and collaboratively in a fast-paced environment. Responsibilities : Prepare and review clinical study protocols, clinical study reports (CSRs), investigator brochures (IBs), and other clinical trial documents in accordance with regulatory guidelines and industry standards. Collaborate with cross-functional teams, including clinical operations, regulatory affairs, and biostatistics, to ensure the accuracy and completeness of medical writing deliverables. Interpret and summarize clinical trial data from various sources, including study reports, statistical analyses, and scientific literature. Assist in the preparation of regulatory submissions, including INDs, NDAs, BLAs, and MAAs, by providing high-quality medical writing support. Participate in project meetings, provide updates on the status of medical writing activities, and contribute to project planning and timelines. Stay current with developments in the field of medical writing, regulatory requirements, and therapeutic areas relevant to our projects. Mentor junior medical writers and provide guidance on best practices for medical writing and document preparation. Qualifications : Bachelor's degree in life sciences, pharmacy, or related field; advanced degree (e.g., MD, PhD, PharmD) preferred. Minimum of 3 years of experience in medical writing within the pharmaceutical, biotechnology, or contract research organization (CRO) industry. Proficiency in interpreting and summarizing clinical trial data, including statistical analyses and safety reports. Strong understanding of regulatory guidelines (e.g., ICH, FDA, EMA) governing the preparation of clinical trial documents and regulatory submissions. Excellent written and verbal communication skills, with the ability to communicate complex scientific concepts clearly and effectively. Detail-oriented with exceptional organizational and time management skills. Ability to work independently and collaboratively in a multidisciplinary team environment. Proficiency in Microsoft Office Suite and familiarity with document management systems (e.g., SharePoint). Benefits : MS Clinical offers a competitive salary and benefits package, including health insurance, retirement plans, and opportunities for professional development and advancement. Show more Show less
Job Title: Finance & Accounts Associate Location: Indiranagar, Bangalore Department: Finance & Accounts Reports to: Finance Manager Experience Required: 0–1 year (Freshers Preferred) Employment Type: Full-time About Us: MS Clinical Research Pvt Ltd (MSCR) is a pioneering clinical research organization committed to advancing healthcare and life sciences through innovative research and collaborations. We are expanding our team and are seeking motivated individuals to help us grow our business footprint. Job Summary: We are looking for a motivated and detail-oriented Finance & Accounts Associate to join our growing finance team. This is an excellent opportunity for a recent graduate or fresher to gain hands-on experience in financial operations, accounting, and compliance within a dynamic and structured environment. Key Responsibilities: Accounting & Bookkeeping Assist in day-to-day accounting tasks, including data entry, invoice processing, and payment follow-ups. Support in maintaining accurate records of Accounts Payable (AP) and Accounts Receivable (AR). Help with bank reconciliations and ledger maintenance. Ensure timely documentation and filing of financial records. Financial Reporting Support in the preparation of monthly and quarterly MIS reports. Assist in compiling data for internal and external audits. Help with trial balance and provision-related work under supervision. Compliance & Taxation Assist in preparing GST, TDS, and income tax filings. Stay updated on basic statutory requirements and support the team in ensuring compliance. Budgeting & Analysis Help in tracking expenses and comparing them with approved budgets. Assist in cost monitoring and reporting of variances. Team Support Collaborate with team members across departments for financial data and approvals. Provide administrative support to senior finance team members as needed. Qualifications & Skills: Education: B.Com / M.Com / MBA (Finance) / CA Inter / CMA Inter or equivalent. Basic knowledge of accounting principles and Indian taxation. Proficiency in MS Excel and willingness to learn accounting software (e.g., Tally, Zoho Books, SAP). Good analytical and numerical skills. Strong attention to detail and organizational skills. Eagerness to learn and grow in the finance domain. Good communication and interpersonal abilities. Why Join Us? Exposure to a full spectrum of finance and accounting processes. Structured learning environment and mentorship from experienced professionals. Opportunity to grow into specialized roles in accounting, taxation, or financial planning. Show more Show less
Job Title: Molecular Biologist – qPCR Consultant (Preclinical – In Vitro) Location: MS Clinical Research Pvt Ltd (MSCR) Department: Preclinical – In Vitro Employment Type: Consultant/ Part- time Experience: Minimum 10 years in Molecular Biology with hands-on expertise in qPCR Role Overview: MSCR is seeking an accomplished Molecular Biologist – qPCR Consultant to support our preclinical (in-vitro) research team. The ideal candidate will bring deep technical expertise in qPCR assay development, optimization, and data analysis, specifically aligned with preclinical drug screening and mechanistic in-vitro studies. This is a strategic consulting role aimed at enhancing our molecular biology capabilities in gene expression, target validation, and biomarker discovery. Key Responsibilities: Provide technical leadership in the design, development, and validation of qPCR assays for in-vitro studies including cytotoxicity, gene expression profiling, and pathway analysis. Advise on sample preparation, RNA/DNA extraction, and quality control specific to in-vitro systems (e.g., cell lines, primary cultures). Guide the team in primer/probe design, assay optimization (SYBR/TaqMan), and standard curve generation. Troubleshoot experimental issues and recommend improvements to protocols and workflows. Ensure robust data integrity, statistical soundness, and scientific documentation of qPCR results. Review experimental designs to align with regulatory and scientific requirements for GLP-compliant preclinical studies. Train lab scientists on best practices for qPCR technique and data interpretation. Collaborate with research scientists and study directors to integrate molecular endpoints in preclinical study design. Stay updated with emerging trends, technologies, and best practices in molecular biology and qPCR. Qualifications: Ph.D. or Master’s in Molecular Biology, Cell Biology, Biotechnology, or a related field. Minimum 10 years of hands-on experience in molecular biology techniques, with a strong focus on qPCR in in-vitro preclinical models. Excellent analytical, documentation, and communication skills. Desirable Skills: Knowledge of cell-based assay systems, molecular endpoints, and biomarker quantification. Exposure to RT-qPCR, miRNA analysis, or multiplex PCR. Understanding of statistical software or qPCR analysis tools (e.g., SDS, CFX Maestro, Bio-Rad CFX, REST). Engagement Type & Compensation: Consulting basis – Part-time, Remote, Hybrid Remuneration commensurate with experience and scope of involvement.
Job Title : Data Analyst Location : Indiranagar, Bangalore Job Type : Full-time Experience : 1-3 years Job Overview We are looking for a skilled Data Management Specialist to support data validation, analysis, and reporting for clinical and preclinical studies. The role involves ensuring data accuracy, resolving discrepancies, and generating insights to support research objectives. Ideal candidates will be detail-oriented, collaborative, and experienced in data handling and compliance. Key Responsibilities: 1. Data Collection & Validation Conduct data validation to identify missing values, inconsistencies, anomalies, and outliers using statistical techniques and automated tools. Implement data cleaning procedures to ensure all data aligns with protocol specifications before processing. 2. Data Processing & Analysis Use statistical and analytical software for exploratory data analysis, statistical modeling, and trend identification. Stay updated on best practices, technologies, and advanced methodologies to enhance analysis and visualization. 3. Reporting & Documentation Maintain proper documentation for all data-related processes and validation steps. Generate data reports and visualizations using tools such as Microsoft Excel, PowerPoint, and Word. Qualifications & Skills: Bachelor’s or Master’s degree in Life Sciences, Data Science, Statistics, or related field. 3 years of experience in data management, preferably in clinical or preclinical research. Proficiency in data analysis tools (e.g., Excel, R, Python) and visualization software. Strong understanding of data cleaning, validation, and quality control practices. Excellent communication, documentation, and team collaboration skills. Personal Attributes : Highly organized with the ability to manage multiple projects and deadlines. Ability to work independently and as part of a team in a fast-paced environment.
Job Title : Clinical Research Associate (CRA) Company : MS Clinical Research Pvt Ltd About Us : MS Clinical Research (MSCR) is a leading clinical research organization dedicated to advancing scientific discovery and improving healthcare outcomes. We are committed to conducting high-quality clinical trials and contributing to the development of innovative medical solutions. Job Summary : We are seeking a highly motivated and experienced Clinical Research Associate (CRA) with a minimum of 2-3 years of relevant experience. The CRA will play a critical role in ensuring the successful planning, execution, and monitoring of clinical trials. The ideal candidate will have a strong understanding of clinical trial processes, regulatory requirements, and excellent communication and organizational skills. Key Responsibilities : Site Management : Conduct site initiation, routine monitoring, and close-out visits to ensure compliance with the study protocol, Good Clinical Practice (GCP), and regulatory requirements. Build and maintain strong relationships with investigative sites, investigators, and study coordinators. Clinical Trial Monitoring : Perform routine monitoring visits to assess site performance, data integrity, and regulatory compliance. Ensure timely resolution of data queries and issues identified during monitoring visits. Protocol Compliance : Ensure that all study activities are conducted in accordance with the approved protocol, SOPs, and applicable regulatory guidelines. Collaborate with investigators to address and resolve protocol-related queries. Regulatory Compliance : Assist in the preparation and submission of regulatory documents to ethics committees and regulatory authorities. Stay informed about changes in regulatory requirements and update study teams accordingly. Data Management : Collaborate with data management teams to ensure accurate and timely data collection and entry. Perform source data verification and data validation activities. Safety Reporting : Monitor and report adverse events in compliance with regulatory requirements and safety reporting procedures. Ensure that safety reports are submitted to relevant authorities and stakeholders. Training and Support : Provide training and support to site staff on study protocols, data collection, and regulatory compliance. Act as a resource for investigators and site staff throughout the duration of the study. Requirements : Education: Bachelor's degree in a relevant life sciences field. Experience : Minimum of 3 years of experience as a Clinical Research Associate. Proven track record of successful site management and monitoring in clinical trials. Regulatory Knowledge: Familiarity with regulatory requirements and guidelines governing clinical trials. Communication Skills : Excellent verbal and written communication skills. Organizational Skills : Strong organizational and time management skills with attention to detail. Team Collaboration : Ability to work effectively in cross-functional teams and independently. Travel : Willingness to travel to investigative sites as needed. Benefits : Competitive salary and benefits package. Opportunities for professional development and advancement. Collaborative and dynamic work environment. Join our team at MS Clinical Research and contribute to the advancement of clinical research and the development of innovative healthcare solutions.
Job Description: Pre-Clinical Lab Manager Position: Pre-Clinical Lab Manager Location: Bengaluru Employment Type: Full-time About Us: MS Clinical Research Pvt Ltd (MSCR) is a pioneering clinical research organization committed to advancing healthcare and life sciences through innovative research and collaborations. We are expanding our team and are seeking motivated individuals to help us grow our business footprint. About the Role: We are seeking a highly skilled and experienced Pre-Clinical Lab Manager to oversee the daily operations of our pre-clinical research laboratory. This role is critical in ensuring compliance with regulatory standards, maintaining laboratory efficiency, and supporting scientific research for pre-clinical studies. The ideal candidate will have a strong background in laboratory management, pre-clinical research, and Good Laboratory Practices (GLP). Key Responsibilities: Laboratory Operations Management: Oversee the day-to-day activities of the pre-clinical lab, ensuring efficiency and compliance with all regulatory requirements. Compliance & Quality Assurance: Ensure adherence to GLP, and other relevant guidelines. Maintain proper documentation and facilitate audits. Team Leadership: Manage and mentor a team of lab technicians, researchers, and support staff, ensuring proper training and performance. Study Coordination: Work closely with researchers to plan and execute pre-clinical studies, including in vivo and in vitro experiments. Equipment & Inventory Management: Oversee the maintenance, calibration, and procurement of lab equipment and supplies to support research activities. Data Management & Reporting: Ensure accurate data collection, analysis, and reporting of pre-clinical study results. Support regulatory submissions and scientific publications. Collaboration: Liaise with internal teams, external partners, and regulatory bodies to facilitate research and ensure compliance with industry standards. Qualifications & Requirements: Masters or Ph.D. in Life Sciences, Pharmacology, Biotechnology, or a related field. 5+ years of experience in a pre-clinical laboratory setting, with at least 2 years in a managerial role. Strong knowledge of GLP and regulatory requirements for pre-clinical research. Experience in handling laboratory techniques used in pre-clinical research. Excellent leadership, organizational, and problem-solving skills. Strong communication skills to interact with multidisciplinary teams and external stakeholders. Preferred Qualifications: Experience in pharmaceutical, Dermatology, Cosmeceuticals biotech, or CRO environments. Certification in laboratory management or regulatory compliance is a plus. Why Join Us Be part of cutting-edge pre-clinical research that drives innovation in healthcare and drug development. Work in a collaborative and dynamic environment with opportunities for career growth. Competitive salary and benefits package. If you are a dedicated professional with a passion for pre-clinical research and laboratory management, we encourage you to apply.,
Job Title: Molecular Biologist – qPCR Consultant (Preclinical – In Vitro) Location: MS Clinical Research Pvt Ltd (MSCR) Department: Preclinical – In Vitro Employment Type: Consultant/Part-time Experience: Minimum 10 years in Molecular Biology with hands-on expertise in qPCR Role Overview: MSCR is seeking an accomplished Molecular Biologist – qPCR Consultant to support our preclinical (in-vitro) research team. The ideal candidate will bring deep technical expertise in qPCR assay development, optimization, and data analysis, specifically aligned with preclinical drug screening and mechanistic in-vitro studies. This is a strategic consulting role aimed at enhancing our molecular biology capabilities in gene expression, target validation, and biomarker discovery. Key Responsibilities: Provide technical leadership in the design, development, and validation of qPCR assays for in-vitro studies including cytotoxicity, gene expression profiling, and pathway analysis. Advise on sample preparation, RNA/DNA extraction, and quality control specific to in-vitro systems. Guide the team in primer/probe design, assay optimization, and standard curve generation. Troubleshoot experimental issues and recommend improvements to protocols and workflows. Ensure robust data integrity, statistical soundness, and scientific documentation of qPCR results. Review experimental designs to align with regulatory and scientific requirements for GLP-compliant preclinical studies. Train lab scientists on best practices for qPCR technique and data interpretation. Collaborate with research scientists and study directors to integrate molecular endpoints in preclinical study design. Stay updated with emerging trends, technologies, and best practices in molecular biology and qPCR. Qualifications: Ph.D. or Master’s in Molecular Biology, Cell Biology, Biotechnology, or a related field. Minimum 10 years of hands-on experience in molecular biology techniques, with a strong focus on qPCR in preclinical models. Excellent analytical, documentation, and communication skills. Desirable Skills: Knowledge of cell-based assay systems, molecular endpoints, and biomarker quantification. Exposure to RT-qPCR, miRNA analysis, or multiplex PCR. Engagement Type & Compensation: Consulting basis – Part-time, Remote, Hybrid Remuneration commensurate with experience and scope of involvement.
About Us: MS Clinical Research Pvt Ltd (MSCR) is a pioneering clinical research organization committed to advancing healthcare and life sciences through innovative research and collaborations. We are expanding our team and are seeking motivated individuals to help us grow our business footprint. Job Summary We are seeking an experienced and detail-oriented Finance and Accounts Manager to oversee and manage all financial aspects of our MS Clinical Research operations. The ideal candidate will have a strong background in financial planning, accounting, compliance, and team management. This role is critical in ensuring the financial health and sustainability of the company while supporting strategic growth. Key Responsibilities Financial Management Develop and implement financial policies, procedures, and controls to ensure accuracy and transparency. Prepare, analyze, and present monthly, quarterly, and annual financial statements and reports. Monitor and manage cash flow to ensure sufficient liquidity for operational needs. Develop budgets and forecasts in alignment with organizational goals. Accounting & Compliance Oversee day-to-day accounting operations, including accounts payable, accounts receivable, payroll, and reconciliations. Ensure compliance with Indian Accounting Standards (IND AS) and other regulatory requirements. Handle statutory filings, including GST, TDS, Income Tax, and other legal compliances. Collaborate with auditors for internal and external audits and ensure timely completion. Cost Management Identify cost-saving opportunities and implement strategies to optimize resources. Analyze operational costs and recommend solutions for financial efficiency. Taxation and Regulatory Compliance Manage corporate tax planning and ensure compliance with all tax regulations. Stay updated with changes in financial laws and regulations and implement necessary updates in processes. Team Leadership Lead and mentor the finance and accounts team to achieve departmental objectives. Conduct performance evaluations, training, and development initiatives for team members. Experience and Qualification 5-10 years of Experience Bachelors or Master's in Finance Required Skills: Proficiency in accounting software (Tally, Zoho Books, SAP, or equivalent). Advanced knowledge of MS Excel and financial reporting tools. Strong understanding of accounting standards (GAAP, IFRS) and tax regulations. Strong analytical and problem-solving abilities. Excellent organizational and time-management skills. Effective communication and leadership skills to manage a team and liaise with stakeholders. Why Join Us? Opportunity to work with a fast-growing clinical research company committed to advancing healthcare. Collaborative work environment with opportunities for professional growth. Competitive compensation and benefits package
As a Cell Biologist at MS Clinical, a leading research organization dedicated to advancing the understanding and treatment of multiple sclerosis (MS), you will play a crucial role in managing various aspects of cell biology research related to multiple sclerosis. Your responsibilities will include performing cellular and molecular biology experiments, designing and troubleshooting experiments, utilizing laboratory techniques such as immunofluorescence and flow cytometry, analyzing experimental data, and collaborating with multidisciplinary teams. You will be expected to maintain accurate records of experiments, stay current with advancements in cell biology and multiple sclerosis research, contribute to the development of research protocols and scientific publications, and integrate cell biology findings into broader research projects. The ideal candidate will have a Bachelor's or Master's degree in Cell Biology, Molecular Biology, Biochemistry, or a related field, along with 5+ years of hands-on experience in cell biology research. Proficiency in cell culture techniques, strong analytical and problem-solving skills, excellent written and verbal communication skills, and the ability to work effectively in a collaborative team environment are essential for this role. Experience with molecular biology techniques and familiarity with laboratory safety protocols are desirable qualifications. In return, MS Clinical offers a competitive salary, comprehensive benefits package, opportunities for professional development and career advancement, and a supportive work environment that values diversity and innovation.,
You are a dynamic and experienced Recruitment & Administrative Lead responsible for overseeing participant enrollment efforts and providing seamless operational support on a day-to-day basis. Your role is crucial as it combines hands-on recruitment, strategic team leadership, administrative tasks, and facility management duties which directly contribute to the success of clinical studies. Your key responsibilities include designing and executing innovative recruitment strategies, leading and mentoring a team of recruiters to achieve enrollment targets, monitoring recruitment metrics, developing relationships with community organizations and healthcare providers, collaborating with other teams, leveraging digital platforms for outreach, maintaining meticulous record-keeping, overseeing administrative functions, managing vendor relationships, ensuring well-maintained facilities, and providing comprehensive administrative support. To qualify for this role, you should have a Bachelors or Masters degree in Life Sciences, Healthcare, HR, Social Work, or a related field, along with at least 5 years of experience in clinical trial recruitment or community outreach, including 2 years in a leadership role. You should possess a strong understanding of clinical research processes, ethical recruitment practices, and regulatory guidelines, as well as excellent communication, organizational, and interpersonal skills. Experience with digital recruitment tools and social media outreach is preferred, and you should be able to work effectively under tight timelines and adapt to changing priorities.,
Job Title: Senior Microbiologist Location: Indiranagar, Bangalore Job Type : Full-time Experience: 5- 10years Key Responsibilities Laboratory Operations and Experiments: - Prepare study protocols aligned with study requirements, applicable Standard Operating Procedures (SOPs), and regulatory guidelines. - Conduct experiments in the laboratory according to established protocols and guidelines. - Ensure the receiving and processing of materials adheres to SOPs. - Isolate or maintain microbial cultures relevant to oral health studies. - Perform microbial sampling as per defined protocols, including analysis for germ protection in clinical trials. - Oversee daily equipment maintenance in each section of the laboratory. - Maintain adequate stock of materials to prevent workflow disruptions. - Ensure cleanliness and carry out disinfection procedures in accordance with applicable SOPs. Quality Control and Reporting: - Report results as per the objectives defined in the protocol and aligned with applicable SOPs. - Maintain accurate logbooks as required by the documentation system. - Perform tests for internal quality control and promptly report any deviations from expected results to the Laboratory Director, taking corrective action as necessary. - Maintain all related documentation in an organized manner. Team Leadership and Development: - Guide, supervise, and train junior staff to maintain the quality of technical work in the section. - Continuously update knowledge and skills in the field, and facilitate training for the team. - Demonstrate professional conduct when interacting with patients, laboratory personnel, healthcare professionals, and the public. Project Management and Coordination: - Develop project plans or follow guidelines provided by professional staff members to outline research procedures. - Schedule projects considering various methods, resource availability, and personnel assigned. - Coordinate with different functional teams to ensure timely completion of projects, including collaboration with laboratory personnel, healthcare professionals, and external stakeholders. - Fulfill any additional duties assigned by the Laboratory Director. Qualification - Master&aposs degree or PhD in Microbiology, Biology, or a related field; specialization in clinical or medical microbiology preferred. - Minimum of 5-7 years of experience in a clinical research or microbiology laboratory, with at least 2 years in a supervisory role. - Proven experience with microbial cultures, sampling, and analysis in research settings, ideally related to infectious diseases or oral health. - Familiarity with regulatory standards such as ICH-GCP, GLP, and SOPs for clinical trials. - Experience in preparing microbiology sections for regulatory submissions is a plus. Skills and Competencies - Strong analytical and problem-solving skills, with attention to detail in experimental design and data interpretation. - Excellent leadership and communication skills for team supervision and cross-functional coordination. - Proficiency in laboratory equipment handling, quality control processes, and documentation systems. - Ability to work independently while fostering a collaborative team environment. - Commitment to professional development and staying current with advancements in microbiology. Show more Show less
As a Senior Microbiologist, your role involves overseeing laboratory operations and experiments, ensuring quality control and reporting, leading and developing a team, and managing projects and coordination effectively. **Key Responsibilities:** - Prepare study protocols aligned with requirements, SOPs, and regulatory guidelines. - Conduct experiments following established protocols and guidelines. - Maintain microbial cultures relevant to oral health studies. - Perform microbial sampling and analysis for germ protection in clinical trials. - Oversee daily equipment maintenance and ensure stock availability. - Report results as per defined objectives and maintain accurate documentation. - Guide, supervise, and train junior staff for maintaining technical quality. - Develop project plans, coordinate with teams, and ensure timely project completion. **Qualification Required:** - Master's degree or PhD in Microbiology or related field; specialization in clinical microbiology preferred. - 5-7 years of experience in a clinical research or microbiology laboratory, with 2 years in a supervisory role. - Experience with microbial cultures, sampling, and analysis in research settings. - Familiarity with regulatory standards like ICH-GCP, GLP, and SOPs for clinical trials. In addition to these qualifications, proficiency in laboratory equipment handling, quality control processes, and documentation systems is essential. Strong analytical and problem-solving skills, excellent leadership and communication abilities, and a commitment to professional development are also key for success in this role.,
Job Title: Quality Assurance (QA) – Clinical Research Experience: 8–10 years Location: Indiranagar, Bangalore Department: Quality Assurance About the Role We are seeking an experienced QA professional to join MSCR, responsible for ensuring the highest standards of quality and compliance across clinical research operations. The ideal candidate will bring strong expertise in ICH-GCP, regulatory guidelines, and clinical QA processes, with the ability to lead audits, drive CAPA, and support continuous quality improvement initiatives. Key Responsibilities Develop and maintain ICH/GCP-compliant processes to control the quality of work and clinical studies at MSCR. Lead and manage internal quality audits, CAPA activities, and quality management reviews. Conduct study audits to ensure adherence to sponsor protocols, GCP, industry guidelines, and regulatory requirements. Identify non-conformances, recommend corrective measures, and drive risk-based continuous quality improvements. Perform vendor audits, collaborate with vendors and production support teams, and implement root cause analysis techniques to strengthen product quality. Deliver training sessions to MSCR staff on QA processes, compliance, and best practices. Support the review, evaluation, and implementation of new technology products and equipment. Review vendor-supplied data and quality records to ensure compliance with documentation standards. Provide QA expertise in special projects as required by management. Perform other QA-related duties as assigned. Requirements 8–10 years of experience in Quality Assurance within clinical research, pharmaceuticals, or life sciences. Strong knowledge of ICH-GCP guidelines, regulatory requirements, and clinical trial processes. Proven experience in internal and external auditing (including vendor audits). Experience in CAPA management and quality risk management methodologies. Ability to conduct root cause analysis and implement sustainable solutions. Strong understanding of Good Documentation Practices (GDP). Excellent communication, presentation, and training skills. Ability to work cross-functionally and manage multiple stakeholders. Preferred Qualifications Prior experience in a clinical research organization (CRO) or clinical trial QA environment. Experience in handling regulatory inspections. Knowledge of electronic systems used in clinical QA.
Job Title : Clinical Research Associate (CRA) Company : MS Clinical Research Pvt Ltd Experience : Minimum 3 years About Us : MS Clinical Research (MSCR) is a leading clinical research organization dedicated to advancing scientific discovery and improving healthcare outcomes. We are committed to conducting high-quality clinical trials and contributing to the development of innovative medical solutions. Job Summary : We are seeking a highly motivated and experienced Clinical Research Associate (CRA) with a minimum of 2-3 years of relevant experience. The CRA will play a critical role in ensuring the successful planning, execution, and monitoring of clinical trials. The ideal candidate will have a strong understanding of clinical trial processes, regulatory requirements, and excellent communication and organizational skills. Key Responsibilities : Site Management : Conduct site initiation, routine monitoring, and close-out visits to ensure compliance with the study protocol, Good Clinical Practice (GCP), and regulatory requirements. Build and maintain strong relationships with investigative sites, investigators, and study coordinators. Clinical Trial Monitoring : Perform routine monitoring visits to assess site performance, data integrity, and regulatory compliance. Ensure timely resolution of data queries and issues identified during monitoring visits. Protocol Compliance : Ensure that all study activities are conducted in accordance with the approved protocol, SOPs, and applicable regulatory guidelines. Collaborate with investigators to address and resolve protocol-related queries. Regulatory Compliance : Assist in the preparation and submission of regulatory documents to ethics committees and regulatory authorities. Stay informed about changes in regulatory requirements and update study teams accordingly. Data Management : Collaborate with data management teams to ensure accurate and timely data collection and entry. Perform source data verification and data validation activities. Safety Reporting : Monitor and report adverse events in compliance with regulatory requirements and safety reporting procedures. Ensure that safety reports are submitted to relevant authorities and stakeholders. Training and Support : Provide training and support to site staff on study protocols, data collection, and regulatory compliance. Act as a resource for investigators and site staff throughout the duration of the study. Requirements : Education: Bachelor's degree in a relevant life sciences field. Experience : Minimum of 3 years of experience as a Clinical Research Associate. Proven track record of successful site management and monitoring in clinical trials. Regulatory Knowledge: Familiarity with regulatory requirements and guidelines governing clinical trials. Communication Skills : Excellent verbal and written communication skills. Organizational Skills : Strong organizational and time management skills with attention to detail. Team Collaboration : Ability to work effectively in cross-functional teams and independently. Travel : Willingness to travel to investigative sites as needed. Benefits : Competitive salary and benefits package. Opportunities for professional development and advancement. Collaborative and dynamic work environment. Join our team at MS Clinical Research and contribute to the advancement of clinical research and the development of innovative healthcare solutions.