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Cra (Level I, Level Ii And Sr Cra)

Thermo Fisher Scientific
Thermo Fisher Scientific
2-7+ years
preferred by company
10 Jan. 2, 2026
Job Description
Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ 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) – Level I, Level II & Senior

Location: Remote, India (Fully Onsite)
Job Type: Full-time
Category: Clinical Research / Clinical Operations
Experience Required: Level I: 2–3 years | Level II: 4–6 years | Senior CRA: 7+ years
Job ID: R-01326248


Overview

Thermo Fisher Scientific’s PPD® clinical research services is a global leader in clinical trials, providing end-to-end support from study startup through monitoring to study close-out across commercial and government contracts. We are seeking Clinical Research Associates (CRA I, CRA II, and Senior CRA) to ensure high-quality, compliant clinical trials while advancing patient safety and data integrity.

This role is remote-based in India but requires onsite monitoring visits to investigative sites as per study requirements. The position offers career growth in clinical operations, exposure to risk-based monitoring, and the opportunity to work with global clinical teams.


Key Responsibilities

  • Conduct and coordinate all aspects of clinical site monitoring, including onsite and remote visits, to ensure compliance with the study protocol, ICH-GCP guidelines, SOPs, and regulatory requirements.

  • Implement risk-based monitoring approaches, applying root cause analysis (RCA) and problem-solving skills to identify site process failures and corrective actions.

  • Ensure accurate and complete data collection via SDV, CRF review, and site documentation.

  • Assess investigational products through inventory checks and records review.

  • Escalate site deficiencies to clinical management and follow up until resolution.

  • Maintain communication with investigative sites between visits to confirm protocol compliance.

  • Participate in investigator meetings, site selection, site initiation, and trial close-out activities.

  • Ensure essential regulatory documents are complete, audit-ready, and compliant with applicable guidelines.

  • Track trial status and report progress to Clinical Team Manager (CTM).

  • Facilitate effective communication between investigative sites, clients, and project teams.

  • Contribute to project tools, publications, and process improvement initiatives.


Required Qualifications

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

  • Valid driver’s license (where applicable).

  • CRA Level I: Minimum 2+ years of clinical monitoring experience.

  • CRA Level II: Minimum 4+ years of clinical monitoring experience.

  • Senior CRA: Minimum 7+ years of clinical monitoring experience with complex trial exposure.


Skills & Competencies

  • Strong understanding of ICH-GCP guidelines, regulatory compliance, and clinical trial procedures.

  • Demonstrated ability in risk-based monitoring, SDV, and site management.

  • Proficient in Microsoft Office and clinical trial management systems.

  • Excellent oral and written communication skills, with the ability to liaise with medical personnel effectively.

  • Critical thinking, problem-solving, and root cause analysis skills.

  • Ability to work independently and in team settings while managing multiple priorities.

  • Detail-oriented with strong organizational and time-management skills.

  • Flexible and adaptable to changing study requirements.

  • Strong interpersonal skills to maintain collaborative relationships with investigative sites and internal teams.


Work Environment

  • Ability to work in non-traditional work environments and maintain productivity under pressure.

  • Independent travel up to XX% (air, train, automobile) to investigative sites.

  • Exposure to healthcare or laboratory environments as required.

  • Ability to use and learn standard office technology and equipment.


Why Join Thermo Fisher Scientific

  • Opportunity to work remotely from India while engaging with global clinical trials.

  • Gain exposure to risk-based monitoring and diverse therapeutic areas.

  • Work with a world-class CRO and grow your career in clinical research operations.

  • Competitive salary and comprehensive benefits supporting work-life balance.

  • Collaborative environment promoting mentorship, professional development, and operational excellence.