REV Clinical is hiring for the position of Jr. CRA (CTA) / Clinical Trial Assistant in Ahmedabad, Gujarat. The opportunity is suitable for B.Pharm, M.Pharm, Pharm.D, and Life Sciences graduates, including freshers, with candidates having 1–2 years of CRC/CTA experience preferred.
The role offers an opportunity to work across clinical trial start-up, site feasibility, regulatory and ethics submissions, Trial Master File (TMF) management, clinical trial supplies, study tracking, and project coordination.
Jr. CRA (CTA) Job Details
| Details | Information |
|---|---|
| Company | REV Clinical |
| Job Title | Jr. CRA (CTA) / Clinical Trial Assistant |
| Location | Ahmedabad, Gujarat |
| Work Mode | Office-based |
| Employment Type | Full Time, Permanent |
| Working Days | 5 Days/Week |
| Experience | Freshers to 2 years |
| Preferred Experience | 1–2 years as CRC/CTA |
| Qualification | B.Pharm / M.Pharm / Pharm.D / Life Sciences |
| Openings | 1 |
| Salary | Not Disclosed |
About the Jr. CRA (CTA) Role
The Clinical Trial Assistant (CTA) will support clinical research projects by assisting with study start-up activities, site feasibility, regulatory documentation, ethics submissions, clinical trial supplies, TMF maintenance, project tracking, and compliance activities.
This position involves close coordination with Clinical Research Associates (CRAs), Project Managers (PMs), investigators, clinical sites, vendors, and other stakeholders.
Key Responsibilities
1. Site Feasibility & Investigator Database
- Develop and maintain site and investigator databases for different clinical trial indications.
- Perform project-specific site-level feasibility assessments.
- Support site identification and shortlisting based on feasibility outcomes.
2. Regulatory & Ethics Submissions
- Collect essential documents from clinical sites for regulatory submissions.
- Coordinate collection of documents such as Investigator Undertaking (IU), Protocol Synopsis/PSP-related documents, CVs, and FDA 1572 where applicable.
- Collect and compile documentation required for Ethics Committee (EC) submissions.
- Prepare and dispatch EC submission dossiers in coordination with the CRA and Project Manager.
- Assist with DCGI documentation and online applications as required.
- Track EC and regulatory submissions and approvals.
3. Clinical Trial Supplies
The candidate will help coordinate the delivery of study-related materials to clinical sites, including:
- Investigator Site Files (ISF)
- Patient/Participant-facing materials
- PK kits
- Central laboratory kits
- Other clinical trial supplies
The role may also involve coordinating with vendors for study-specific inclusion/exclusion materials and other site materials.
4. Trial Master File & Documentation
- Prepare and maintain site files and Trial Master Files (TMF).
- Maintain project trackers and study documentation.
- Draft routine project communications.
- Periodically review TMF completeness.
- Follow up with CRAs and Project Managers on outstanding action items.
5. Clinical Study Start-Up & Project Coordination
- Track clinical study start-up activities.
- Report study progress to the Project Manager.
- Support site agreement activities.
- Assist with weekly and monthly project status reports.
- Coordinate with different stakeholders to keep study activities on schedule.
6. Clinical Trial Registry & Compliance
- Register and update applicable studies on the Clinical Trials Registry – India (CTRI).
- Support resolution of QA audit findings in consultation with the CRA and Project Manager.
- Ensure activities follow applicable GCP, Schedule Y, and Quality Management System (QMS) requirements.
Eligibility Criteria
Candidates should meet the following requirements:
- B.Pharm, M.Pharm, Pharm.D, or Life Sciences qualification.
- Freshers can apply.
- Candidates with 1–2 years of CRC or CTA experience will be preferred.
- Strong verbal and written communication skills.
- Good coordination and documentation abilities.
- Basic understanding of clinical research and clinical trials.
- Knowledge of ICH-GCP and regulatory requirements.
- Ability to work effectively with CRAs, Project Managers, clinical sites, and other stakeholders.
Key Skills
Candidates interested in Clinical Trial Assistant jobs should have or develop knowledge of:
- Clinical Research
- Clinical Trial Management
- Clinical Operations
- CTA activities
- CRC activities
- ICH-GCP
- Site Feasibility
- Regulatory Submissions
- Ethics Committee Submissions
- TMF Management
- Study Start-Up
- Clinical Trial Supplies
- Project Coordination
- Clinical Trial Documentation
Who Can Apply?
This Jr. CRA / Clinical Trial Assistant vacancy in Ahmedabad can be relevant for:
- B.Pharm graduates
- M.Pharm graduates
- Pharm.D graduates
- Life Sciences graduates
- Freshers looking to start a career in clinical research
- Clinical Research Coordinators (CRCs)
- Clinical Trial Assistants with relevant experience
- Professionals transitioning into clinical operations
Candidates with previous experience in CRC, CTA, clinical research, or study start-up activities may find their experience particularly relevant to the position.
Job Location and Work Schedule
The position is based in Ahmedabad, Gujarat, and the vacancy specifies an office-based working arrangement.
The position follows a 5-day working week.
How to Apply
Application Link for Jr. CRA (CTA) Official
Application Link for Jr. CRA (CTA) Through Naukri
