Experienced Clinical Research Associate

Role Overview

This opportunity is for an experienced Clinical Research Associate based in Navi Mumbai, India. The role sits within a full-service clinical research organization that supports Phase I to Phase IV development for biotechnology, pharmaceutical, and medical device programs. The organization works across major therapeutic areas and combines scientific rigor with strong regulatory expertise to help move studies efficiently toward approval.

What the Role Involves

• Plan and perform qualification, site initiation, monitoring, and closeout visits in line with the approved study protocol.
• Maintain regular communication with site personnel, including coordinators, physicians, and other research staff.
• Confirm that investigators have the right qualifications, training, facilities, equipment, laboratory support, and staffing to conduct the study properly.
• Check source records and medical documentation against case report forms, flag data-entry issues, reinforce proper documentation practices, and report protocol deviations according to SOPs, GCP, and regulatory rules.
• Ensure that only eligible participants are enrolled by the investigator.
• Review regulatory documents for completeness and compliance.
• Track investigational product or medical device accountability and inventory.
• Assess adverse events, serious adverse events, concomitant medications, and related illnesses to ensure accurate reporting in accordance with the protocol.
• Evaluate patient recruitment and retention performance at the site and suggest improvements where needed.
• Prepare monitoring visit reports and follow-up letters summarizing key findings, deviations, deficiencies, and recommended corrective actions.

Training and Career Development

No prior research experience is required for candidates who can learn quickly and adapt well, as a structured training program is provided. The training pathway is designed to build confidence, strengthen CRA capabilities through practical exercises and discussions, and support progression toward independent CRA responsibilities. Additional rotations across clinical research functions may also be part of the learning experience to broaden understanding of drug and device development.

Who Typically Succeeds in This Role

People with backgrounds in healthcare and science-related fields often do well in this position, including nurses, dieticians, pharmacy technicians, pharmaceutical or device sales representatives, biotech engineers, PhD or Pharm.D candidates, health and wellness coordinators, and research assistants.

Additional Benefits

• Dynamic work setting with changing responsibilities from day to day.
• Exposure to a wide range of therapeutic areas.
• Collaboration with therapeutic and regulatory specialists.
• Clear growth path for promotion, mentoring, and leadership opportunities.
• Competitive compensation with the possibility of a travel bonus.
• Flexible work arrangement, with a home-based option available for CRAs who have more than 1 year of monitoring experience.
• Competitive pay and benefits package.
• Competitive paid time off package.
• Structured career progression with room for professional development.
• Employee appreciation events sponsored by the company.
• Health and wellness initiatives for employees.

Candidate Requirements

• Bachelor’s degree is required.
• At least 2 to 4 years of experience working as a Clinical Research Associate.
• Willingness to travel approximately 60% to 80% across India.
• Working knowledge of Microsoft Office.
• Strong communication and presentation abilities are preferred.

About the Organization

The company is a global clinical research organization with more than 30 years of work supporting patients across many disease areas. It operates in 40+ countries, employs more than 5,000 people, and is recognized for its quality, expertise, reliability, and compatibility. Its therapeutic coverage includes oncology, cardiology, metabolic disease, endocrinology, central nervous system conditions, and anti-viral and anti-infective areas.

Awards and Recognition

• Named by Forbes as one of America’s Most Successful Midsize Companies in 2021, 2022, 2023, and 2024.
• Repeatedly recognized with CRO Leadership Awards from Life Science Leader magazine.

Next Steps

A team member will review applications and contact shortlisted candidates with the next steps if the profile matches the role.