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Cra (Level I, Level Ii And Sr Cra)

Thermo Fisher Scientific
Thermo Fisher Scientific
0-2 years
Not Disclosed
10 Jan. 14, 2026
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Clinical Research Associate (CRA I, CRA II, Sr. CRA) – India
Location: Remote, India | Job Type: Full-Time | Category: Clinical Research | Work Model: Onsite/Remote

Company Overview:
Join Thermo Fisher Scientific / PPD Clinical Research Services, a global leader in clinical research, dedicated to bringing life-changing therapies to patients worldwide. Our Clinical Research team supports end-to-end clinical trials across commercial and government contracts, helping clients plan, execute, and close high-quality, cost-efficient studies in over 100 countries.

Position Summary:
The CRA (Level I, II, or Senior) plays a key role in monitoring and managing clinical trial sites to ensure compliance with protocols, ICH-GCP, sponsor SOPs, and regulatory requirements. This role ensures subject safety, data integrity, and audit readiness, while supporting study teams in risk-based monitoring and site management.

Key Responsibilities:

  • Conduct on-site and remote monitoring visits to assess protocol adherence, regulatory compliance, and site performance.

  • Verify data accuracy through source document review (SDR/SDV) and case report form (CRF) validation.

  • Perform investigational product accountability checks, including inventory and documentation.

  • Escalate and track site deficiencies, ensuring timely corrective and preventive actions (CAPAs).

  • Maintain regular communication with site staff to monitor protocol adherence and resolve issues.

  • Conduct site initiation, routine monitoring, and trial close-out activities.

  • Ensure essential documents are complete, accurate, and in place according to ICH-GCP and regulatory requirements.

  • Update study systems (e.g., CTMS) and provide trial status reports to Clinical Team Managers (CTM).

  • Participate in investigator meetings and site selection activities.

  • Contribute to process improvement initiatives, study publications, and training of new team members.

Qualifications:

  • Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or equivalent academic qualification.

  • CRA I: 0–2 years of relevant clinical research experience.

  • CRA II: 2–5 years of experience in clinical trial monitoring and site management.

  • Sr. CRA: 5+ years of experience with demonstrated leadership in monitoring and site oversight.

  • Knowledge of ICH-GCP, local regulations, and clinical trial procedures.

  • Strong analytical, critical thinking, and problem-solving skills.

  • Excellent oral and written communication, organizational, and interpersonal skills.

  • Ability to work independently and in a team environment.

  • Proficiency in Microsoft Office and other relevant clinical software.

  • Valid driver’s license as applicable; readiness to travel to clinical sites.

Work Environment:

  • Ability to work upright and stationary for typical office hours.

  • Exposure to non-traditional work environments and healthcare/lab settings.

  • Flexible and adaptable, capable of handling multiple projects under pressure.

  • Travel required (percentage depends on study assignment; includes local and long-distance travel).

Why Join Us:
This role provides a dynamic opportunity to gain hands-on experience across clinical trials, develop monitoring expertise, and contribute to improving global health outcomes. CRAs at Thermo Fisher/PPD work with cross-functional teams, innovative clinical programs, and cutting-edge clinical research technologies.