Job Description Job Title: Senior Clinical Research Associate (Lead CRA)
n Company: MS Clinical Research Pvt. Ltd.
n Location: Bengaluru, India
n About MS Clinical Research
n 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.
n Job Summary
n 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, strong knowledge of FDA regulations and ICH-GCP guidelines, and the ability to independently manage multiple clinical trial sites and stakeholder relationships.
n Preference will be given to candidates who hold a valid US Visa and are willing to travel internationally as required.
n Key Responsibilities
n Clinical Trial & Site Oversight
n n Independently manage and oversee clinical trial activities across multiple sites.
n Conduct and review Site Qualification, Initiation, Monitoring, and Close-Out Visits.
n Ensure compliance with study protocols, sponsor requirements, ICH-GCP, FDA regulations, and local regulatory requirements.
n Provide oversight for a minimum of 10 clinical trial sites across multiple studies.
n n US Clinical Trial Management
n n Support and manage clinical studies involving US investigative sites and sponsors.
n Collaborate with US-based investigators, CROs, sponsors, and cross-functional teams.
n Ensure adherence to FDA regulations, 21 CFR requirements,



and applicable international guidelines.
n Participate in sponsor meetings, study review meetings, and project governance discussions.
n n Monitoring & Quality Management
n n Review monitoring reports and site performance metrics.
n Ensure timely resolution of monitoring findings, protocol deviations, and data queries.
n Oversee source data verification, essential documents, and Trial Master File quality.
n Support audit and inspection readiness activities.
n n Regulatory & Compliance
n n Ensure compliance with ICH-GCP, FDA regulations, institutional requirements, and company SOPs.
n Review regulatory submissions, ethics committee documentation, and study-related communications.
n Maintain inspection-ready documentation throughout the study lifecycle.
n n Safety Management
n n Ensure timely reporting and follow-up of Adverse Events (AEs) and Serious Adverse Events (SAEs).
n Support investigators and study teams in meeting safety reporting requirements.
n n Leadership & Mentorship
n n Mentor and guide CRAs and junior clinical operations team members.
n Provide operational leadership and contribute to process improvements.
n Serve as a subject matter expert for monitoring, site management, and compliance-related activities.
n n Sponsor & Stakeholder Management
n n Act as a key point of contact for sponsors and study stakeholders.
n Present study updates, site performance metrics,



risks, and mitigation plans.
n Foster solid relationships with investigators, site personnel, and sponsors.
n n Qualifications
n Education
n n Bachelor's or Master's degree in Life Sciences, Pharmacy, Biotechnology, Nursing, or a related discipline.
n n Experience
n n Minimum 10 years of clinical research experience.
n Minimum 5 years of independent monitoring experience.
n Proven experience managing US-based clinical trials and/or US investigative sites.
n Experience handling at least 10 clinical trial sites independently.
n Prior experience in a Lead CRA, Senior CRA, Clinical Trial Manager, or Project Management role preferred.
n n Required Skills
n n Robust knowledge of FDA regulations, ICH-GCP, and global clinical trial regulations.
n Experience working with US sponsors and international study teams.
n Excellent leadership, stakeholder management, and communication skills.
n Strong project planning, risk management, and problem-solving abilities.
n Ability to manage multiple studies and priorities effectively.
n n Preferred Qualifications
n n Valid US Business/Tourist Visa (B1/B2) or eligibility to travel internationally.
n Experience supporting FDA inspections and regulatory audits.
n Exposure to global, multicenter clinical trials.
n Experience across multiple therapeutic areas.
n n Travel Requirements
n n Willingness to travel domestically and internationally, including travel to the United States as required.
n n Benefits
n n Competitive compensation package.
n International exposure and sponsor-facing opportunities.
n Leadership and career advancement opportunities.
n Collaborative and growth-oriented work environment.
n

📌 Lead Clinical Research Associate (Bengaluru)
🏢 MS CLINICAL RESEARCH
📍 Bengaluru