Job Title: Clinical Research Associate (CRA I, CRA II, Sr. CRA) – Remote/Onsite, India
Job ID: R-01326248
Job Type: Full-time
Category: Clinical Research
Location: Remote/Onsite, India
Thermo Fisher Scientific’s Clinical Research Services, through its PPD® portfolio, is a global leader in advancing healthcare by delivering innovative therapies. Conducting clinical trials across more than 100 countries, our teams provide end-to-end support for clinical trials from study start-up to close-out, across commercial and government contracts.
We are seeking Clinical Research Associates (CRA I, CRA II, and Sr. CRA) to monitor clinical trials, ensure regulatory compliance, and maintain high-quality data for life-changing therapies. This role provides opportunities to work with diverse investigational sites, cross-functional teams, and global clients while driving operational excellence and patient safety.
Conduct remote and on-site monitoring visits to ensure protocol compliance, patient safety, and data integrity.
Apply risk-based monitoring approaches, including root cause analysis and corrective/preventive actions, to ensure site compliance and mitigate study risks.
Perform source data verification (SDV), clinical data review, and CRF validation as applicable.
Assess investigational product accountability through inventory review and documentation.
Escalate deficiencies and follow-up on resolutions with clinical management and project teams.
Maintain regular communication with investigative sites between visits to confirm adherence to protocol and timely data submission.
Initiate clinical trial sites and facilitate investigator meetings in alignment with protocol and regulatory requirements.
Conduct trial close-out procedures, ensure essential documents are complete, and maintain audit readiness.
Prepare monitoring reports, trial status updates, and ensure clinical trial management systems are updated per project requirements.
Support cross-functional teams with process improvement initiatives, project publications, and clinical study tools.
Education: Bachelor’s degree in Life Sciences, Pharmacy, or a Registered Nursing qualification; advanced degree preferred.
Experience: Minimum 2+ years for CRA I and CRA II; 5+ years for Sr. CRA or equivalent experience in on-site clinical research monitoring.
Valid driver’s license where applicable.
Experience with risk-based monitoring and regulatory compliance in clinical trials.
Proven clinical monitoring skills and understanding of medical/therapeutic areas.
Knowledge of ICH-GCP guidelines, applicable regulations, and SOPs.
Strong critical thinking, problem-solving, and root cause analysis capabilities.
Excellent written, verbal, and presentation skills.
Effective interpersonal skills with ability to build collaborative relationships with investigative sites.
Strong organizational, time management, and multitasking abilities.
Flexibility to adapt in diverse monitoring scenarios and work independently or in a team.
Proficiency in Microsoft Office and clinical trial management software.
High attention to detail and commitment to quality.
May involve travel up to XX%, including automobiles, airplanes, and trains.
Work performed in office, clinical, or non-traditional settings.
Ability to work under pressure while managing multiple projects.
Exposure to healthcare or laboratory environments is possible.
Global Impact: Contribute to innovative clinical research and life-changing therapies across the globe.
Career Growth: Access comprehensive learning programs, mentoring, and opportunities to advance within Clinical Operations.
Collaborative Culture: Work alongside experienced professionals in a supportive, knowledge-sharing environment.
Work-Life Balance: Flexible working culture with support for remote and onsite work.
Competitive Compensation: Attractive salary and comprehensive benefits focused on employee health, well-being, and career development.
About Thermo Fisher Scientific
Thermo Fisher Scientific is a global leader in serving science, employing 100,000+ colleagues worldwide. Our mission is to enable customers to make the world healthier, cleaner, and safer. We advance life sciences research, improve patient outcomes, and support scientific discovery through innovation, collaboration, and integrity. Learn more at www.thermofisher.com.
Equal Opportunity Employer: Thermo Fisher Scientific fosters a diverse, inclusive, and equitable workplace.
Apply Now to join a global team of experts driving clinical research excellence and advancing patient care.
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