Jr CRA (CTA)

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
  
• Strong 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.