Job Title: Clinical Research Associate (CRA)
Experience Required: 4–6 Years
Educational Qualification: B.Pharm / M.Pharm / M.Sc
Location: Ahmedabad
Job Description
We are looking for a dedicated Clinical Research Associate (CRA) to join our dynamic clinical research team in Ahmedabad. The ideal candidate will have hands-on experience in conducting clinical trials, ensuring compliance with regulatory guidelines, and supporting the research process from initiation to completion.
Key Responsibilities
Study Management: Oversee and manage clinical trials, ensuring that they are conducted according to the study protocol, applicable regulations, and Good Clinical Practice (GCP) guidelines.
Site Monitoring: Perform site selection, initiation, monitoring, and close-out visits. Ensure sites meet all compliance, regulatory, and operational standards.
Data Collection and Analysis: Ensure proper collection and documentation of trial data. Review data for completeness, accuracy, and compliance with the study protocol.
Collaboration: Coordinate with cross-functional teams, including project managers, investigators, and regulatory teams, to ensure smooth trial execution.
Regulatory Compliance: Maintain up-to-date knowledge of regulatory requirements, including GCP, ICH, and local regulations. Ensure adherence to all ethical and regulatory guidelines.
Reporting and Documentation: Generate and review clinical trial documents such as monitoring visit reports, and ensure timely submission of clinical data and documents to regulatory bodies.
Training and Support: Provide guidance and training to clinical trial staff, including site personnel, on study protocols and regulatory requirements.
Candidate Requirements
Educational Background:
Bachelor’s or Master’s degree in Pharmacy (B.Pharm / M.Pharm) or Life Sciences (M.Sc).
Experience:
4–6 years of experience in clinical research, specifically in clinical monitoring, clinical trials, or clinical operations.
Knowledge and Skills:
Strong knowledge of GCP, ICH guidelines, and regulatory requirements.
Excellent understanding of clinical trial processes, from site initiation to close-out.
Ability to interpret clinical data and regulatory documents.
Strong organizational, problem-solving, and time management skills.
Excellent written and verbal communication skills.
Certifications (Preferred):
CRA certification (e.g., ACRP or SOCRA) is preferred but not mandatory.
Why Join Us?
Work with a leading team in the clinical research field and gain exposure to diverse projects.
Competitive compensation and career growth opportunities.
A collaborative and inclusive work environment.
Access to ongoing professional development and training.
Take the next step in your clinical research career by applying for the CRA position in Ahmedabad. Help us bring life-changing therapies to market and improve global health outcomes!
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