Job Title: Senior Clinical Research Associate (Lead CRA)
Company: MS Clinical Research Pvt. Ltd.
Location: Bengaluru, India
About MS Clinical Research
MS Clinical Research (MSCR) is a leading clinical research organization dedicated to advancing innovative therapies through high-quality clinical research. We partner with global sponsors and research sites to deliver clinical trials that meet the highest standards of scientific excellence, quality, and regulatory compliance.
Job Summary
MSCR is seeking a highly experienced Senior Clinical Research Associate (Lead CRA) with 10+ years of experience in clinical research and proven expertise in managing US-based clinical trials. The ideal candidate will have extensive monitoring and project oversight experience, solid knowledge of FDA regulations and ICH-GCP guidelines, and the ability to independently manage multiple clinical trial sites and stakeholder relationships.
Preference will be given to candidates who hold a valid US Visa and are willing to travel internationally as required.
Key Responsibilities
Clinical Trial & Site Oversight
- Independently manage and oversee clinical trial activities across multiple sites.
- Conduct and review Site Qualification, Initiation, Monitoring, and Close-Out Visits.
- Ensure compliance with study protocols, sponsor requirements, ICH-GCP, FDA regulations, and local regulatory requirements.
- Provide oversight for a minimum of 10 clinical trial sites across multiple studies.
US Clinical Trial Management
- Support and manage clinical studies involving US investigative sites and sponsors.
- Collaborate with US-based investigators, CROs, sponsors, and cross-functional teams.
- Ensure adherence to FDA regulations, 21 CFR requirements, and applicable international guidelines.
- Participate in sponsor meetings, study review meetings, and project governance discussions.
Monitoring & Quality Management
- Review monitoring reports and site performance metrics.
- Ensure timely reso
📌 Lead Clinical Research Associate (Bengaluru)
🏢 MS CLINICAL RESEARCH
📍 Bengaluru
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