Position: Clinical Research Associate (CRA)
Number of Openings: 01
Location: Ahmedabad- WFO

Job Responsibilities
- Prepare, review, and maintain Standard Operating Procedures (SOPs).
- Review study protocols, informed consent forms, and other essential clinical trial documents.
- Identify, evaluate, and maintain a database of potential investigator sites.
- Conduct site selection, site initiation, monitoring, and close-out visits in accordance with study timelines and GCP guidelines.
- Train investigators and site personnel on study protocols, trial procedures, and regulatory requirements.
- Coordinate vendor selection and oversee vendor-related activities.
- Ensure timely availability, distribution, reconciliation, and accountability of clinical trial supplies at investigational sites.
- Perform source data verification (SDV) and ensure data accuracy, integrity, and compliance with study protocols and regulatory requirements.
- Monitor protocol compliance and promptly report any non-compliance or significant issues to the appropriate stakeholders.
- Prepare, review,



and circulate monitoring visit reports within defined timelines.
- Follow up on monitoring observations and ensure timely resolution of action items.
- Collaborate with cross-functional teams, including Clinical Data Management (CDM), Biostatistics, and Quality Assurance (QA), to resolve data queries and study-related observations.
- Review study documentation and reports to ensure quality and regulatory compliance.
- Ensure timely reporting and documentation of Adverse Events (AEs), Serious Adverse Events (SAEs), protocol deviations, and other safety-related events in accordance with applicable regulatory and sponsor requirements.

Eligibility Criteria
- 1–3 years of experience as a Clinical Research Associate (CRA).
- Candidates with 2+ years of experience as a Clinical Research Coordinator (CRC) are also encouraged to apply.
- Excellent written and verbal communication skills.
- Robust knowledge of

📌 Clinical Research Associate (Ahmedabad)
🏢 GSC Technolabs Private
📍 Ahmedabad