11 Irb Submissions Jobs

As a Regulatory Specialist, you will be responsible for the following key responsibilities: - Bachelor's degree in Life Sciences, Clinical Research, Science, Healthcare Administration, or a related field. - 25 years of regulatory experience in clinical research or pharmaceutical environments. - CITI certifications (GCP, HSC, RCR, COI, IPS, IATA, ICH, CRC) required within two weeks of hire; training will be provided. - Familiarity with IRB submissions, study start-up activities, and regulatory document maintenance. - Proficiency with CRIO (Clinical Research IO) or similar electronic platforms used for eISF and study documentation. - Experience with Clinical Trial Management Systems (CTMS), El...

Role Overview: You will be responsible for managing a team of regulatory specialists and ensuring timely regulatory submissions to support study start up. As a Manager at Velocity Clinical Research, you will proactively address challenges, drive efficiency, and provide guidance on regulatory compliance. Key Responsibilities: - Manage a team of regulatory specialists to ensure timely and efficient regulatory submissions. - Prepare study-specific documents such as protocols, informed consent forms, and HIPAA authorizations for review by the IRB. - Submit and manage amendments, adverse event reports, and other IRB-required submissions. - Provide guidance on conflict of interest paperwork and ma...

Your role as a candidate will involve: - Assisting in subject recruitment, screening, and informed consent processes - Collecting, entering, and managing clinical trial data and documentation - Scheduling study visits, communicating with study participants - Ensuring regulatory and ethical compliance (e.g., ICH-GCP, IRB submissions) Qualifications required: - Proficiency in subject recruitment, data management, and regulatory compliance - Excellent communication skills and attention to detail This is a full-time position with benefits such as health insurance and Provident Fund. The work schedule is day shift, and the work location is in person.,

Job Summary RTL/Sr. RTL is responsible and accountable for deliveries of studies allocated to RCO unit, performing end to end study related project management for studies managed in-house with-in agreed timelines, budget and desired quality standards. For Outsourced study, RTL/Sr. RTL will be responsible to provide an efficient Sponsor Oversight and accountable for key deliverables and study success. RTL/Sr. RTL is expected to adhere to required procedures and quality in compliance with Sun Procedural Documents, ICH-GCP and local regulations. Area Of Responsibility Planning and Execution of trials as per agreed timelines, budget and ensuring Quality across processes. Planning and Facilitatin...

Job Summary LTM is responsible and accountable for deliverables of studies assigned to RCO unit, performing end to end study related onsite/ remote monitoring, quality data review, essential documents management for studies managed in-house with-in agreed timelines, budget and desired quality standards. LTM is expected to adhere to required standard operating procedures, regulatory requirements, ICH GCP and quality in compliance with Sun Procedural Documents. Area Of Responsibility Ensures clinical trials are conducted at assigned sites as per protocol, local regulatory requirements, ICH GCP, ensure data integrity, patient safety and trials are conducted as per ethical standards (declaration...

Role Overview: As a RTL/Sr. RTL, you will be responsible for managing the end-to-end project management of studies allocated to the RCO unit. This includes ensuring study deliveries within agreed timelines, budget, and quality standards. For outsourced studies, you will provide efficient Sponsor Oversight and be accountable for key deliverables and study success. Adherence to required procedures and quality standards in compliance with Sun Procedural Documents, ICH-GCP, and local regulations is expected from you. Key Responsibilities: - Plan and execute trials within agreed timelines, budget, and quality standards - Coordinate with the IRA team for planning and facilitating HA submission - C...

As a Lead Trial Manager (LTM) at the RCO unit, you will be responsible for the successful delivery of studies assigned to you. Your role will involve performing end-to-end study-related onsite and remote monitoring, ensuring quality data review, and managing essential documents for in-house studies within agreed timelines, budget, and quality standards. Your key responsibilities will include: - Ensuring that clinical trials are conducted at assigned sites in compliance with the protocol, local regulatory requirements, ICH GCP, and ethical standards - Acting as the primary communication point between SPIL and clinical trial sites for site management activities - Facilitating regulatory submis...

Oversees multiple regulatory specialists at clinical research sites, ensuring timely regulatory submissions, IRB documentation, compliance with evolving regulations, training oversight, audit coordination, and accurate maintenance of study records, while demonstrating advanced communication, leadership, multitasking, and regulatory knowledge.

The job involves providing clinical study start-up expertise and assisting the Lead CRA in preparing IRB submissions, including reviewing site-specific informed consent and assent forms. You will be responsible for tracking IRB submissions, collecting, reviewing, and processing essential documents, as well as identifying any issues that the site needs to address. Communicating updates needed to essential documents to the site is also an essential part of the role. Additionally, you will lead or support the setup and maintenance of the Trial Master File (TMF) and assist or participate in planning and conducting Investigators Meetings as necessary. This is a full-time position that offers the ...

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, yo...

As a Manager of Clinical Research at The Ayurveda Experience, you will be responsible for leading and managing clinical trials and research studies to ensure timely delivery, budget adherence, and compliance with regulatory standards. In this role, you will supervise research teams, collaborate with cross-functional departments, and provide strategic direction to achieve high-quality research outcomes that align with the company's mission. Your responsibilities will include planning, initiating, and overseeing clinical research projects from start to finish while ensuring adherence to protocols, timelines, budgets, and Good Clinical Practice (GCP) standards. You will lead and mentor clinical...