08 Nov
|
REV Clinical
|
Bengaluru
08 Nov
REV Clinical
Bengaluru
Senior Clinical Research Associate (Sr. CRA)
Company: REV Clinical
Experience: 5-6 Years
Location: Ahmedabad, Delhi, Bangalore, Mumbai
Industry: Clinical Research / CRO
Employment Type: Full-time
REV Clinical is looking for an experienced Senior Clinical Research Associate (Sr. CRA) with solid hands-on experience in Oncology clinical trial monitoring. The candidate will be responsible for independently managing clinical trial sites, conducting monitoring visits, ensuring regulatory compliance, and maintaining study quality in accordance with ICH-GCP guidelines and applicable regulations.
Key Responsibilities
- Manage clinical trial sites and ensure compliance with study protocols, SOPs, ICH-GCP, and regulatory requirements.
- Conduct Site Qualification (SQV), Site Initiation (SIV), Interim Monitoring (IMV), and Close-Out (COV) visits.
- Perform Source Data Verification (SDV) and Source Document Review (SDR).
- Review CRFs/eCRFs, Investigator Site Files, and Trial Master Files (TMF).
- Ensure IP accountability and timely resolution of data queries and protocol deviations.
- Identify site-level risks and ensure appropriate corrective actions.
- Coordinate with investigators, site staff, Project Managers, and sponsors.
- Prepare and submit monitoring visit reports within defined timelines.
- Support audits, regulatory activities, and site close-out procedures.
- Guide and mentor junior CRAs and clinical research staff.
Required Qualifications & Skills
- Master's in Life Sciences / M.Pharm / Pharm.D.
- 56 years of experience as a Clinical Research Associate.
- Mandatory hands-on Oncology clinical trial monitoring experience.
- Experience in conducting SQV, SIV, IMV, COV, and pre-audit visits.
- Strong knowledge of ICH-GCP, clinical trial regulations, and SOPs.
- Hands-on experience in SDV/SDR, IP accountability, and TMF maintenance.
- Excellent written and verbal English communication skills.
- Strong site management, problem-solving, and stakeholder management skills.
- Willingness to travel to clinical trial sites.
About REV Clinical REV Clinical (formerly CBCC Global Research) is a multinational Clinical Research Organization (CRO) headquartered in Bakersfield, California, with operations in Ahmedabad, India. The organization provides end-to-end clinical research services across multiple therapeutic areas, including Oncology, CNS, and Ophthalmology, supporting Phase IIV clinical trials.
Interested candidates: Apply with your updated CV.
📌 Senior Clinical Research Associate (Sr. CRA) (Bengaluru)
🏢 REV Clinical
📍 Bengaluru