Job Title: Clinical Trial Assistant (CTA) / Jr. CRA (Fresher 2 year Exp.)
Location: Ahmedabad (Office-based)
Working Days: 5 Days/Week
We are looking for M.Pharm / B.Pharm freshers with strong communication skills.
Candidates with 1-2 years of experience as CRC/CTA will be preferred.
Preferred Candidate Profile
- M.Pharm / B.Pharm graduate
- Excellent verbal & written communication
- Solid coordination and documentation skills
- Basic understanding of clinical research, GCP, and regulatory guidelines
Key Responsibilities Identification and development of a robust Site/Investigator database for different indications.
- Perform project-specific site-level feasibility assessments.
- Shortlist sites based on feasibility assessment outcomes.
- Collect essential study documents from sites (IU, PSP, CV, FDA 1572, etc.) for regulatory submissions.
- Collect and compile documents required for Ethics Committee (EC) submissions.
- Prepare and dispatch EC dossiers to sites in consultation with CRA / PM.
- Prepare and dispatch DCGI dossiers to the DCGI liaison or assist PM with online DCGI applications.
- Track EC and DCGI submissions and approvals.
- Coordinate clinical trial supplies to sites (ISF, PF, PK kits, central lab kits, etc.).
- Finalize study materials and coordinate with vendors for dispatch of inclusion/exclusion materials (cards, posters, keychains).
- Assist PM in execution of site agreements.
- Prepare and maintain site files, Trial Master Files (TMF), trackers, and draft communications.
- Track and report study start-up activities to the Project Manager.
- Register and update studies on the Clinical Trial Registry of India (CTRI).
- Periodically review TMF completeness and follow up on open action items with CRA / PM.
- Assist in resolution of QA audit findings in consultation with CRA / PM.
- Support PM in preparation of weekly and monthly project status reports.
- Ensure compliance with GCP, Schedule Y, and Quality Management System (QMS) requirements.
- Perform other duties as assigned by CRA, PM, Head-PM, or Designee.
📌 Jr CRA (CTA) (Ahmedabad)
🏢 REV Clinical
📍 Ahmedabad
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