Key Responsibilities Provide clinical study start up expertise. Assist Lead CRA in the preparation of IRB submissions including the review of the sitespecific informed consent and assent forms Track IRB submissions Collect, review, and process essential documents and identify issues that site needs to address. Communicate to site the updates needed to the essential documents as needed. Lead or support set-up and maintenance of TMF Assist and/or participate in planning and conduct of Investigator’s Meetings as necessary. Job Type: Full-time Pay: ₹25,542.00 - ₹40,320.00 per month Benefits: Work from home
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 benefit of working from home.,
Responsibilities Oversight of the clinical trials start-up process from receipt of protocols through the Scientific Review Committee and IRB submissions, and site activation activities. Responsible for data reporting and management, collection of source documents, use and development of case report forms, adverse events reporting, filing and archiving of study records, and resolution of data queries. Prepare and or complete regulatory related reports and IRB submissions. Maintain and organize study regulatory binders, enter all required study data on an ongoing basis. Ensure all study related samples are collected, properly prepared and shipped according to the protocol requirements and IATA/DOT regulations. Responsible for organizing and preparing for both internal and external auditing and study monitoring visits. Coordination and management of clinical trials, including communication with Sponsors and regulatory authorities. Close-out of clinical trials, including contributing to research articles, audit preparation, and communication with regulatory agencies and other disciplines involved. Interact with study participants as directed/required by the protocol and/or study team. May be responsible for tissue sample work. Job Type: Full-time Pay: ₹25,500.00 - ₹38,000.00 per month Benefits: Internet reimbursement Ability to commute/relocate: Ahmadabad District, Gujarat: Reliably commute or planning to relocate before starting work (Required) Education: Bachelor's (Preferred) Experience: total work: 1 year (Preferred) Work Location: In person