Job Title: Clinical Research Associate (CRA – Level I, Level II & Senior CRA)
Job ID: R-01326248
Location: Remote – India
Employment Type: Full-Time
Work Model: Remote / Onsite as per study requirements
Industry: Clinical Research | Contract Research Organization (CRO)
Thermo Fisher Scientific, through its PPD® Clinical Research Services, is a global leader in clinical research and drug development. With clinical trials conducted in over 100 countries, the organization supports pharmaceutical, biotechnology, and government clients in bringing life-changing therapies to market. Thermo Fisher Scientific is driven by its mission to enable a healthier, cleaner, and safer world through science and innovation.
Thermo Fisher Scientific is hiring Clinical Research Associates (CRA Level I, Level II, and Senior CRA) to support end-to-end clinical trial operations across global studies. This role is part of the Clinical Operations team within PPD® and involves site monitoring, regulatory compliance, risk-based monitoring, and stakeholder collaboration to ensure high-quality, compliant, and efficient clinical trial execution.
Perform and coordinate all aspects of clinical site monitoring and site management
Conduct remote and on-site monitoring visits in compliance with protocol, ICH-GCP, SOPs, and regulatory requirements
Apply risk-based monitoring (RBM) principles, including root cause analysis (RCA) and corrective/preventive actions
Perform SDR, SDV, and CRF reviews to ensure data accuracy and integrity
Assess investigational product accountability through inventory and records review
Prepare monitoring reports, follow-up letters, and documentation in a timely manner
Escalate site issues and deficiencies to clinical management and track resolution
Support site initiation, routine monitoring, and study close-out activities
Ensure audit and inspection readiness at all assigned sites
Maintain effective communication with investigators, site staff, sponsors, and internal project teams
Update clinical systems such as CTMS and maintain essential trial documentation
Participate in investigator meetings, site selection, and feasibility activities as required
Contribute to process improvement initiatives and project-level deliverables
CRA Level I: Minimum 2+ years of on-site clinical monitoring experience
CRA Level II: Typically 3–5 years of independent monitoring experience
Senior CRA: Typically 5+ years of clinical monitoring experience with advanced site and study responsibilities
(Experience equivalency may be considered based on education, training, and relevant clinical research exposure.)
Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, or related field
Registered Nursing (RN) qualification or equivalent healthcare qualification may be considered
Proven experience in clinical monitoring and site management
Strong working knowledge of ICH-GCP, regulatory guidelines, and clinical trial processes
Experience with risk-based monitoring methodologies
Excellent critical thinking, problem-solving, and root cause analysis skills
Strong written and verbal communication skills in English
Ability to manage multiple priorities and meet timelines
High attention to detail and strong documentation skills
Proficiency in Microsoft Office and ability to learn clinical trial systems
Ability to work independently as well as within cross-functional teams
Willingness to travel as per study requirements
Standard business schedule (Monday to Friday)
Combination of remote work and site-based activities
Ability to work under pressure and manage multiple studies
Travel may be required depending on project needs
Work on global, high-impact clinical trials
Be part of a leading global CRO with strong career development opportunities
Exposure to diverse therapeutic areas and advanced clinical research models
Competitive compensation, structured growth paths, and a science-driven culture
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