Clinical Research Associate (CRA I, CRA II, Senior CRA) – Remote, India
Job ID: R-01326248
Job Type: Full-Time
Category: Clinical Research / Clinical Operations
Work Mode: Fully Onsite
About the Role
Thermo Fisher Scientific is seeking experienced Clinical Research Associates (Level I, II, and Senior CRA) to join our global Clinical Operations team. This role provides an opportunity to contribute to the delivery of high-quality clinical trials supporting life-changing therapies. As a CRA, you will coordinate and oversee clinical trial activities, ensuring compliance with protocols, regulatory requirements, and ICH-GCP standards, while fostering strong relationships with investigative sites.
Our Clinical Operations team delivers end-to-end support across study start-up, monitoring, and close-out phases for commercial, government, and FSP models. This role offers global exposure, hands-on monitoring experience, and opportunities to develop advanced clinical trial skills.
Key Responsibilities
Conduct on-site and remote monitoring visits to ensure protocol adherence, regulatory compliance, and accurate data collection.
Apply risk-based monitoring (RBM) strategies, including root cause analysis and corrective/preventive actions, to identify and mitigate site process deviations.
Verify data accuracy through source data verification (SDV), source document review (SDR), and case report form (CRF) checks.
Monitor investigational products through physical inventory checks and record reviews.
Prepare timely, high-quality monitoring reports, follow-up letters, and documentation per client and SOP standards.
Collaborate with investigative sites, clients, and internal teams to resolve issues and maintain study integrity.
Participate in study start-up activities, including site initiation, investigator selection, and essential document review.
Ensure audit readiness by maintaining complete and compliant study documentation.
Facilitate investigator meetings, training, and site close-out procedures.
Maintain administrative responsibilities, including timesheets, expense reports, and updates in Clinical Trial Management Systems (CTMS).
Education & Experience Requirements
Bachelor’s degree in Life Sciences, Nursing, or a related field; relevant professional certifications are a plus.
Minimum 2+ years of onsite clinical research monitoring experience for CRA I/II; Senior CRA typically requires 5+ years.
Valid driver’s license where applicable.
Experience in FSP, FSO, or global CRO settings preferred.
Knowledge, Skills & Competencies
Strong understanding of ICH-GCP guidelines, regulatory requirements, and clinical trial procedures.
Demonstrated proficiency in medical/therapeutic knowledge, terminology, and clinical monitoring practices.
Excellent critical thinking, problem-solving, and risk assessment skills.
Ability to manage RBM concepts effectively.
Strong oral, written, and presentation skills with the ability to communicate effectively with medical personnel and stakeholders.
Proficient in Microsoft Office and clinical trial systems (CTMS, EDC).
Strong organizational, time management, and multitasking skills.
Flexibility and adaptability to work in a variety of clinical and non-traditional environments.
Ability to work independently or as part of a team while maintaining confidentiality and data integrity.
Work Environment & Travel
Work in a professional office, laboratory, or clinical environment.
May involve exposure to potentially hazardous elements typical of healthcare or laboratory settings.
Independent travel up to XX%, including automobiles, airplanes, and trains.
Ability to work upright and remain focused for extended periods while managing multiple priorities.
Why Join Thermo Fisher Scientific
Global Exposure: Work on international clinical trials across therapeutic areas, collaborating with global teams, CROs, and investigative sites.
Professional Growth: Advance your clinical operations career through mentorship, learning pathways, and exposure to advanced monitoring and FSP models.
Impactful Work: Contribute to high-quality clinical studies that improve patient outcomes worldwide.
Supportive Environment: Flexible work culture, strong emphasis on health, safety, and work-life balance.
Thermo Fisher Scientific is a world leader in serving science, enabling customers to make the world healthier, cleaner, and safer. We are an Equal Opportunity Employer committed to diversity, equity, and inclusion.
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Frank Scottile Blvd |Missouri :
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Sheffield |Oxfordshire :
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