Job Title: Clinical Trial Assistant (CTA) / Junior Clinical Research Associate (Jr CRA)
Location: Ahmedabad, India (Office-Based)
About CBCC Global Research:
CBCC Global Research is a leading clinical research organization dedicated to advancing healthcare through innovative research and development. We are committed to maintaining the highest standards of quality and ethics in all our clinical trials. We offer a dynamic and supportive work environment where talented individuals can thrive and contribute to meaningful advancements in medicine.
Job Summary:
We are seeking a motivated and detail-oriented Clinical Trial Assistant (CTA) / Junior Clinical Research Associate (Jr CRA) to join our growing team in Ahmedabad. This is an excellent opportunity for recent M.Pharm/B.Pharm graduates or candidates with 0-1 year of experience in clinical research to gain valuable experience in a dynamic and supportive environment. The CTA/Jr CRA will support various aspects of clinical trial management, including site feasibility, regulatory submissions, study start-up, and project management activities.
Responsibilities:
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Site Feasibility & Investigator Management:
- Build and maintain a comprehensive investigator/site database.
- Conduct thorough site-level feasibility assessments to evaluate potential research sites.
- Shortlist suitable sites based on feasibility assessments and study requirements.
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Regulatory & Ethics Submissions:
- Collect essential regulatory documents from potential and participating sites (e.g., IU/PSP/CV/FDA 1572).
- Prepare and compile submissions for Ethics Committees (EC) and the Drugs Controller General of India (DCGI).
- Track the status of submissions, manage approvals, and maintain accurate submission logs.
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Study Start-Up & Site Coordination:
- Coordinate the shipment and tracking of clinical trial supplies (e.g., ISF, Patient Files, PK kits, lab kits).
- Manage vendor coordination related to the procurement and delivery of study materials.
- Provide support to Project Managers (PMs) and Clinical Research Associates (CRAs) with site agreements, Trial Master File (TMF) management, trackers, and general site communication.
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Registry & Documentation Compliance:
- Register clinical studies on the Clinical Trials Registry – India (CTRI) and maintain study information updates.
- Periodically review the Trial Master File (TMF) to ensure completeness and address any documentation gaps.
- Assist in addressing findings from Quality Assurance (QA) audits.
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Reporting & Quality Assurance:
- Prepare regular project status reports (weekly/monthly) to keep stakeholders informed of progress.
- Ensure strict compliance with international standards (ICH-GCP), Schedule Y guidelines, Standard Operating Procedures (SOPs), and the Quality Management System (QMS).
Requirements:
- Educational Qualification: M.Pharm / B.Pharm / M.Sc (Science) degree.
- Experience: Fresh graduates or candidates with 0-1 year of relevant experience.
- Skills:
- Excellent verbal and written communication skills.
- Solid understanding of clinical research principles, Good Clinical Practice (GCP), and regulatory processes.
- Strong coordination and documentation skills.
- Ability to work independently and as part of a team.
Preferred Qualifications:
- Prior experience (1-2 years) as a Clinical Research Coordinator (CRC) is an advantage.
Benefits:
- Opportunity to begin your career as a CTA/Jr CRA in a reputable clinical research organization.
- Exposure to a wide range of clinical trial activities, including regulatory submissions, site management, and project management.
- Mentorship and guidance from experienced CRAs and PMs.
- Career growth opportunities within Clinical Operations.
- 5-day work week.
How to Apply:
Interested candidates are encouraged to apply by submitting their resume and cover letter. Please highlight your relevant skills and experience, and explain why you are interested in this position. We look forward to hearing from you!