Job Opportunity: Clinical Research Associate (CRA) – Delhi

Job Summary

Catalyst Clinical Services is seeking a highly motivated and experienced Clinical Research Associate (CRA) to join our team in Delhi. This role is designed for professionals passionate about clinical research, quality assurance, and regulatory compliance. As a vital member of our clinical operations team, you will be responsible for overseeing the integrity of clinical trials, ensuring that all site activities adhere to rigorous ICH-GCP guidelines and protocol requirements. If you have a background in on-site monitoring and are looking to advance your career within a dynamic, innovation-focused environment, we encourage you to apply.

Responsibilities

As a Clinical Research Associate, your primary goal is to ensure the successful execution and oversight of clinical trials. Your daily responsibilities will include:

• On-Site Monitoring: Conducting Site Initiation Visits (SIV), Interim Monitoring Visits (IMV), and Close-Out Visits (COV) in strict accordance with trial protocols.
• Compliance Oversight: Ensuring all site activities are compliant with ICH-GCP guidelines, local regulatory standards, and sponsor-specific requirements.
• Data Integrity: Reviewing clinical site data to guarantee accuracy, completeness, and adherence to established protocols.
• Quality Management: Proactively identifying potential quality issues, protocol deviations, or risks at the site level and escalating them to the project team for resolution.
• Stakeholder Coordination: Serving as the primary point of contact between investigators, site staff, and sponsors to foster clear communication and collaboration.
• Documentation & Audit Readiness: Supporting the maintenance of clinical trial documentation, including Trial Master Files (TMF/eTMF), and ensuring sites are fully prepared for audits and regulatory inspections.
• Timeline Management: Managing site-specific timelines and deliverables to ensure clinical trials remain on schedule.

Requirements

To be successful in this role, candidates must meet the following criteria:

• Education: A Bachelor’s or Master’s degree in Life Sciences, Pharmacy, or a closely related field.
• Experience: A minimum of 2 years of professional on-site monitoring experience, or documented completion of 50+ monitoring visits.
• Regulatory Knowledge: A deep understanding of clinical trial processes, ICH-GCP guidelines, and relevant regulatory requirements.
• Professional Skills: Excellent interpersonal, communication, and coordination skills, with a proven ability to solve complex problems independently.
• Mobility: A willingness and ability to travel frequently to various investigator sites as required by the study protocols.
• Preferred Qualifications: Experience managing multi-center clinical trials, familiarity with eTMF systems, and a demonstrated history of supporting successful regulatory inspections.

Benefits

At Catalyst Clinical Services, we value our employees and provide a professional environment conducive to long-term career growth. Benefits of this position include:

• Competitive Compensation: An annual salary range of ₹6,00,000 – ₹10,00,000, commensurate with experience and expertise.
• Professional Development: Continuous learning opportunities focused on GCP excellence, advanced monitoring techniques, and global regulatory affairs.
• Career Advancement: A clear trajectory for growth within clinical operations and exposure to large-scale global trials.
• Collaborative Environment: The chance to work with diverse investigator sites and a supportive, high-performing team dedicated to bringing life-changing therapies to market.
• Global Impact: The opportunity to contribute to high-quality research that has a meaningful impact on patient care and public health.

How to Apply

If you meet the requirements and are ready to take the next step in your career, we would love to hear from you. Please submit your updated curriculum vitae (CV) and a cover letter detailing your relevant monitoring experience to:

Email: [email protected]

Catalyst Clinical Services is an equal opportunity employer. We review all applications carefully and will contact qualified candidates to discuss the next steps in our hiring process.