Role Purpose
The Senior Clinical Research Associate (Senior CRA) is responsible for supporting and overseeing the successful execution of clinical trials by ensuring protocol compliance, patient safety, data quality, site performance, regulatory compliance, and adherence to study timelines. The role involves monitoring and oversight of study sites, coordination with sponsors and cross-functional teams, identification and resolution of study risks, and mentoring of junior clinical research staff.
Detailed Responsibilities
· Support and coordinate clinical trial activities from study start-up through study close-out in accordance with the protocol, ICH-GCP, applicable regulations, and company SOPs.
· Participate in study kick-off meetings and support development and implementation of study plans, timelines, and deliverables.
· Coordinate with sponsors, internal cross-functional teams, CRAs, sites, and external vendors to ensure timely and effective study execution.
· Review key study documents including Protocol, ICF, CRF/eCRF, CMP, DMP, and other essential documents, as required.
· Support site feasibility, site selection, PSSVs, EC submissions, CTRI registration, and SIV activities.
· Conduct and/or oversee monitoring activities, including SIV, SMV, and SCV, as per the approved monitoring plan.
· Review monitoring reports and ensure timely follow-up and resolution of site findings, queries, deviations, and action items.
· Monitor site performance, recruitment, protocol compliance, data quality, IP accountability, and overall study progress.
· Maintain effective sponsor communication and provide timely updates on study status, risks, issues, timelines, and deliverables.
· Proactively identify and escalate study risks, compliance issues, recruitment challenges, and operational delays, and support appropriate mitigation actions.
· Coordinate implementation of protocol amendments, scope changes, and other study changes in accordance with approved requirements.
· Review site and vendor invoices and support budget and vendor-related activities, as required.
· Support study close-out activities, including SCV, database lock readiness, essential document reconciliation, PMF completion, archival, and sponsor deliverables.
· Support audits and regulatory inspections by ensuring study and site documentation is complete, accurate, and inspection-ready.
· Mentor and guide Junior CRAs and CTAs and support improvement in their study-related performance and deliverables.
Educational Qualification
· Bachelor's or Master's degree in Life Sciences, Pharmacy, Medicine, Nursing, Biotechnology, or another relevant healthcare/scientific discipline.
· Postgraduate Diploma/Certification in Clinical Research is preferred.
· Additional training/certification in ICH-GCP, Clinical Research, Clinical Trial Management or related areas is preferred.
Experience
· 4–6 years of relevant experience in clinical research, including a minimum of 2 years of experience as a Clinical Research Associate (CRA).
· Hands-on experience in clinical trial monitoring, site management and study conduct.
· Experience in sponsor communication and cross-functional coordination.
· Experience in managing site performance, recruitment, protocol compliance, data quality and study timelines.
· Experience in mentoring or guiding Junior CRAs/CTAs is preferred.
· Experience working with CTMS, EDC, eTMF and other clinical trial systems is preferred.
· Experience in CRO or sponsor environments and exposure to global/multicentric clinical trials is preferred.
Pay: ₹300,000.00 - ₹600,000.00 per month
Application Question(s):
- Have you worked as CRA for minimum 2+ years?
- Have you lead a team, if yes of how many members?
- Did you had direct communication with Sponsors?
- This is work from office Mon-Fri, Location - Pune ( Karvenagar) No Hybrid, WFO
Is this feasible for you?
Work Location: In person
