Premier Research is hiring a Clinical Trial Associate II to join its Global Clinical Monitoring and Site Management team in Bangalore, India. This opportunity is ideal for professionals with experience in clinical trial operations, TMF/eTMF management, CTMS systems, and ICH-GCP compliance.
Premier Research works with biotech, medtech, and specialty pharmaceutical companies to transform innovative research into life-saving medicines, medical devices, and diagnostics. As a Clinical Trial Associate II, you will play a key role in clinical trial documentation, site management support, and regulatory compliance throughout the trial lifecycle.
This position offers strong exposure to global clinical research operations, trial master file management, and clinical data tracking systems, making it an excellent opportunity for professionals looking to grow in the clinical research and CRO industry.
Key Responsibilities
TMF & Document Management
- Maintain Trial Master File (TMF) and electronic Trial Master File (eTMF) in compliance with sponsor SOPs and regulatory requirements.
- Create and maintain placeholders and filing structures according to TMF filing plans.
- Review site documentation to ensure compliance with regulatory authorities, company standards, and ALCOA+ principles.
- Conduct quality review and completeness checks of TMF sections throughout study startup, maintenance, and close-out.
- Follow up with the clinical team to resolve TMF queries and compliance issues.
- Generate and distribute eTMF reports to support study quality and regulatory compliance.
Clinical Systems & Data Management
- Assist in CTMS setup and data entry for clinical study tracking.
- Maintain site contact information, site activation records, and vendor activities.
- Track distribution of Investigatorโs Brochure, safety reports, and other regulatory documents.
- Manage user access for systems such as:
- CTMS
- EDC
- IWRS
- Vendor platforms
- Monitor training compliance matrices for the clinical team.
Study Coordination & Support
- Support CRAs and clinical teams with essential document collection and review.
- Assist with study startup, maintenance, and close-out documentation.
- Participate in internal clinical meetings and study tracking activities.
- Coordinate with vendors for site equipment, translations, and study materials.
- Assist in preparing Investigator Site Files (ISF) and pharmacy site files before Site Initiation Visits.
Operational & Team Support
- Support tracking tools such as Q&A logs and issue logs.
- Assist with clinical team training documentation.
- Mentor or train junior CTAs where required.
- Identify and escalate operational issues to project teams or line managers.
Eligibility Criteria
Educational Qualification
- Undergraduate degree in:
- Life Sciences
- Nursing
- Medical Documentation
- Clinical Research
- Or related healthcare discipline
Equivalent education and relevant experience may also be considered.
Experience
- Minimum 1 year of experience as a Clinical Trial Associate (CTA) or similar role in clinical research.
Required Skills
- Knowledge of ICH-GCP guidelines
- Understanding of clinical trial essential documents
- Familiarity with ALCOA+ data integrity principles
- Experience with clinical research systems such as:
- CTMS
- eTMF
- EDC
- Strong MS Office skills (Word, Excel, PowerPoint, Outlook)
- Excellent organizational and time management skills
- Strong communication and interpersonal skills
- Ability to work independently and in cross-functional clinical teams
Salary & Benefits
Estimated Salary Range: โน6,00,000 โ โน10,00,000 per year (based on industry benchmarks)
Additional benefits may include:
- Hybrid work model
- Global CRO exposure
- Professional training programs
- Career development opportunities
- Collaborative international research environment
Job Details
| Job Role | Clinical Trial Associate II |
|---|---|
| Company | Premier Research |
| Location | Bangalore, India |
| Job Type | Full-time |
| Work Mode | Hybrid |
| Experience | Minimum 1 year |
| Industry | Clinical Research / CRO |
How to Apply
