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
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