🧾 Position Title:
Senior Clinical Research Associate (Sr. CRA)
Location: Bangalore, India
Department: Clinical Research
Job Type: Full-Time
Position Level: Associate
🧭 Overview
We are seeking a Senior Clinical Research Associate to join our growing Clinical Operations team. The Sr. CRA will be responsible for overseeing and executing all aspects of clinical trial management, including site selection, initiation, monitoring, and closeout, in compliance with ICH-GCP, local regulatory requirements, and company SOPs.
This role requires a proactive individual with strong communication, regulatory understanding, and site management skills to ensure the successful conduct of clinical studies.
🎯 Key Responsibilities
1. Compliance & Regulatory Oversight
Conduct all activities in accordance with ICH E6 (GCP) guidelines and applicable SOPs.
Ensure study conduct meets ethical and regulatory standards at all times.
Facilitate and support regulatory submissions for assigned studies.
2. Study Start-Up
Perform feasibility assessments to evaluate potential investigator sites.
Conduct site selection activities and facilitate investigator/site contract negotiations.
Support the development and local adaptation of study-specific documents.
Oversee the set-up of the Trial Master File (TMF) and ensure proper maintenance throughout the study.
Coordinate and participate in Investigator Meetings.
3. Study Conduct & Site Management
Conduct site initiation visits (SIVs) and monitoring visits in line with study plans.
Maintain consistent communication with investigator sites, clients, and vendors.
Resolve site-level issues promptly, escalating to the Project Manager (PM) as necessary.
Support the PM or Project Team Lead (PTL) with project updates, status reports, and client meetings.
Ensure accurate and timely Case Report Form (CRF) retrieval and query resolution.
Maintain an up-to-date Trial Master File (TMF) throughout the study lifecycle.
4. Study Close-Out
Lead site close-out visits and ensure proper documentation completion.
Contribute to final study reports and close-out documentation.
Support audit readiness and post-study archival of essential documents.
🧠 Required Qualifications
Education: Bachelor’s or Master’s degree in Life Sciences or related field.
Experience: Minimum 3 years of on-site monitoring experience in clinical research.
Knowledge:
Strong understanding of ICH-GCP principles.
Familiarity with local regulatory requirements governing clinical trials.
💡 Desirable Skills & Attributes
Excellent organizational and time-management abilities.
Strong written and verbal communication skills.
Detail-oriented, proactive, and capable of independent decision-making.
Effective collaborator in cross-functional clinical teams.
Ability to handle multiple projects and deadlines simultaneously.
🧩 Position Highlights
Work within a dynamic, growth-oriented clinical research environment.
Collaborate with global and local teams to ensure high-quality clinical trial delivery.
Opportunity to enhance leadership, monitoring, and regulatory expertise in the CRO or sponsor setting.
Gujarat :
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Siliguri |Illinois :
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Netherlands |Remote Australia :
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Queensland |Melbourne :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Canada |Quebec :
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Brussels |Antwerp :
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Argentina | Peru |Brazil :
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Greece |North Island :
Auckland |New Zealand :
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Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
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Ho Chi Minh City |Italy :
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South Africa | Midrand |Nišava District :
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