Veeda CR is hiring for the position of Clinical Research Associate (CRA) in Ahmedabad, Gujarat. The role focuses on off-site clinical monitoring, site feasibility assessments, ICH-GCP compliance, clinical trial documentation, site personnel training, and audit support.
The company is seeking candidates with 3–7 years of experience in clinical research and a B.Pharm or M.Pharm qualification. There are 2 openings for this full-time, permanent position.
Job Details
| Particulars | Details |
|---|---|
| Company | Veeda CR |
| Job Title | Clinical Research Associate (CRA) |
| Job Location | Ahmedabad, Gujarat |
| Experience | 3–7 years |
| Salary | ₹3.5–5.5 LPA |
| Number of Openings | 2 |
| Employment Type | Full-time, Permanent |
| Industry | Pharmaceutical & Life Sciences |
| Qualification | B.Pharm or M.Pharm |
| Key Focus Areas | Clinical Monitoring, Site Feasibility, ICH-GCP Compliance |
Position
Clinical Research Associate (CRA)
The selected candidate will support clinical trial activities through off-site monitoring visits, site readiness assessments, documentation, regulatory compliance, personnel training, and coordination with study sites.
Roles and Responsibilities
1. Off-Site Clinical Monitoring
- Conduct off-site visits at different phases of the study according to the study plan.
- Conduct initial site visits to train and guide site personnel.
- Verify protocol prerequisites and assess site readiness before study initiation.
- Perform routine monitoring visits at predetermined intervals in accordance with study guidelines.
2. Site Feasibility and Communication
- Coordinate feasibility assessment questionnaires with potential study sites.
- Collect the necessary information from sites for feasibility review.
- Follow up regularly with off-site nodal personnel and site in-charges.
- Coordinate study-related updates and ensure timely communication.
3. Clinical Trial Documentation
- Prepare and submit monitoring reports for review, including:
- Pre-Study Qualification Report
- Site Initiation Visit Report
- Site Monitoring Visit Report
- Site Closeout Visit Report
- Collect prerequisite documents, including calibration reports and agreements, from sites and vendors.
- Provide logs, forms, source data templates, recruitment trackers, and feasibility questionnaires to the off-site team.
- Ensure data is captured and recorded using the prescribed formats.
4. Regulatory Compliance and Audit Support
- Review study-related documents for compliance with SOPs, protocols, and regulatory requirements.
- Train and guide off-site team members on study protocols, Good Clinical Practice (GCP), root cause analysis, and updated regulatory requirements.
- Respond to queries raised by internal QA/QC teams and external sponsor or regulatory auditors.
Eligibility and Qualifications
Candidates should meet the following requirements:
- Educational qualification: B.Pharm or M.Pharm in any specialization.
- Work experience: 3–7 years of experience.
- Relevant background: Clinical research experience involving off-site monitoring, site feasibility assessments, clinical trial documentation, and ICH-GCP compliance.
Required Skills
The key skills relevant to this Clinical Research Associate position include:
- Clinical Research
- Clinical Operations
- Clinical Monitoring
- Site Monitoring
- Site Initiation
- Site Feasibility Assessment
- ICH-GCP Compliance
- Clinical Trials
- Clinical Trial Documentation
- Protocol and SOP Compliance
- Audit Support
- Site Personnel Training
