Clinical Research Specialist (Bengaluru)

MS CLINICAL RESEARCH; Bengaluru; On-site; INR 900,000 - 1,500,000; Full time

Benefits offered by this job

Competitive compensation

Leadership development

Collaborative environment

Job summary

MS Clinical Research Pvt Ltd in Bengaluru is seeking a Clinical Research Associate (CRA) / Senior Clinical Research Coordinator with 3–5 years of clinical trial monitoring and site management experience. The role requires ensuring regulatory compliance, maintaining data integrity, and mentoring junior CRAs and CRCs.

You will oversee site visits, manage regulatory submissions, collaborate with investigators, and support quality, safety reporting, and risk-based monitoring to drive study success.

Qualifications

• Bachelor's or Master's degree in Life Sciences or related field.
• Minimum 3 years as a Clinical Research Associate/CRC with independent site management.

Responsibilities

• Oversee site initiation, monitoring, and close-out visits per protocol and GCP.
• Maintain regulatory compliance and prepare regulatory submissions.
• Mentor junior CRAs/CRCs and support site staff.
• Ensure data integrity, timely query resolution, and documentation per SOPs.
• Support safety reporting and adverse event documentation.
• Collaborate with data management and project teams to ensure data quality.
• Participate in audits and implement corrective actions.

Skills

Communication

Interpersonal skills

Analytical

Organizational skills

Education

Life Sciences degree

Job description

Job Title: Clinical Research Associate (CRA)/ Senior Clinical Research Coordinator

Company: MS Clinical Research Pvt Ltd

Experience: Minimum 3 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 Clinical Research Associate (CRA/ Sr.CRC) with a minimum of 5 years of relevant experience in clinical trial monitoring and site management. The CRA will be responsible for overseeing the conduct of clinical trials, ensuring regulatory compliance, maintaining data integrity, and mentoring junior CRAs and CRCs. 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/ CRCs.
• Serve as a subject matter expert and key resource for protocol-related and operational queries.

Requirements

• Education: Bachelors or Masters degree in Life Sciences or a related field.
• Experience: Minimum 3 years as a Clinical Research Associate/Clinical Research Coordinator, 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 advantages 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.