Are you looking for a rewarding career in clinical research? Premier Research is hiring a Clinical Trial Associate II to join their Global Clinical Monitoring and Site Management team in Bangalore, India. This is a hybrid, full-time role where you’ll contribute to groundbreaking medical advancements while enjoying flexibility and growth opportunities.
About Premier Research
Premier Research is a leading clinical research organization (CRO) dedicated to helping biotech, medtech, and specialty pharma companies bring life-changing therapies to patients. Their work is crucial in transforming breakthrough science into innovative medicines, devices, and diagnostics.
Why Join Premier Research?
✔ Built for You – Grow your skills with flexibility and work-life balance.
✔ Built by You – Your ideas and voice shape the way they work.
✔ Built with You – Be part of a team that delivers medical innovation to patients in need.
Job Description: Clinical Trial Associate II
As a Clinical Trial Associate II, you will play a key role in ensuring clinical trial documentation is maintained efficiently and complies with regulatory standards.
Key Responsibilities:
Document Management
- Maintain Trial Master File (TMF)/eTMF in compliance with SOPs and regulatory requirements.
- Review site documents for accuracy and completeness (ALCOAC standards).
- Perform quality checks on eTMF sections and resolve discrepancies.
- Assist with essential document collection during study startup, maintenance, and close-out.
- Support translation of site documents (if required).
Data Entry, Tracking, and Reporting
- Assist with CTMS setup and data entry (site updates, activation tracking).
- Track Investigator’s Brochure, safety reports, and site communications.
- Manage system access (CTMS, EDC, IWRS) for site staff and clinical teams.
- Review training compliance for clinical teams.
Additional Duties
- Attend internal meetings and assist with follow-ups.
- Support vendor coordination (study equipment, translations).
- Assist in study material development (Investigator Site Files, pharmacy binders).
- Mentor junior CTAs and participate in departmental initiatives.
Qualifications & Skills
- Bachelor’s degree in Life Sciences or related field.
- 2+ years of experience in clinical trials or TMF/document management.
- Knowledge of ICH-GCP, regulatory guidelines, and eTMF systems.
- Strong organizational, communication, and problem-solving skills.
- Proficiency in CTMS, EDC, and other clinical trial software.
