Senior Clinical Research Associate

Job Title: Senior Clinical Research Associate (Sr. CRA)

Company: MS Clinical Research Pvt Ltd

Experience: Minimum 5 years

About Us

MS Clinical Research (MSCR) is a leading clinical research organization committed to advancing scientific innovation and improving healthcare outcomes. We conduct high-quality clinical trials that adhere to global standards of excellence and contribute to the development of breakthrough medical solutions.

Job Summary

We are seeking an experienced and proactive Senior Clinical Research Associate (Sr. CRA) with a minimum of 5 years of relevant experience in clinical trial monitoring and site management. The Sr. CRA will be responsible for overseeing the conduct of clinical trials, ensuring regulatory compliance, maintaining data integrity, and mentoring junior CRAs. This role requires exceptional organizational, analytical, and communication skills, along with the ability to build strong site relationships and ensure study success.

Key Responsibilities

Site Management & Oversight

• Conduct and oversee site initiation, interim monitoring, and close-out visits in accordance with study protocols, GCP, and applicable regulatory guidelines.
• Build and maintain strong professional relationships with investigators, site coordinators, and key stakeholders.
• Proactively identify and resolve site issues to ensure quality and compliance.

Clinical Trial Monitoring

• Perform comprehensive monitoring visits to assess site performance, data accuracy, and adherence to protocol.
• Ensure timely follow-up on monitoring findings, query resolution, and documentation in compliance with SOPs.
• Support risk-based monitoring activities and provide oversight to ensure data reliability.

Protocol & Regulatory Compliance

• Ensure that all trial activities comply with study protocols, SOPs, and local/international regulations.
• Participate in the preparation and review of regulatory submissions and ethics committee communications.
• Stay updated on evolving regulatory requirements and communicate changes to project teams.

Data & Quality Management

• Oversee source data verification and ensure timely data entry and validation.
• Collaborate with data management and project teams to maintain high data quality and consistency.
• Participate in internal and external audits, ensuring readiness and corrective actions where needed.

Safety & Reporting

• Monitor, document, and report adverse events in accordance with safety protocols and regulatory timelines.
• Support investigators in ensuring prompt and accurate safety reporting.

Training & Mentorship

• Provide ongoing training, mentoring, and support to site staff and junior CRAs.
• Serve as a subject matter expert and key resource for protocol-related and operational queries.

Requirements

• Education: Bachelor’s or Master’s degree in Life Sciences or a related field.
• Experience: Minimum 5 years as a Clinical Research Associate, with demonstrated success in independently managing clinical sites.
• Regulatory Knowledge: Strong understanding of ICH-GCP, local and international regulatory requirements, and clinical trial conduct.
• Skills:
• Excellent communication and interpersonal abilities.
• Strong analytical, organizational, and problem-solving skills.
• Proficiency in documentation, reporting, and time management.
• Collaboration: Ability to work independently as well as collaboratively within cross-functional teams.
• Travel: Willingness to travel extensively to investigative sites as required.

Benefits

• Competitive compensation and comprehensive benefits package.
• Professional growth and leadership development opportunities.
• Supportive, collaborative, and innovation-driven work environment.

Join MS Clinical Research and play a key role in driving clinical excellence and advancing the future of medical innovation.