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Clinical Research Associate (Cra)

2+ years
Not Disclosed
10 Nov. 25, 2025
Job Description
Job Type: Full Time 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 CRA

Location: Remote, India
Employment Type: Full-Time
Category: Clinical Research
Work Model: Fully Onsite
Job ID: R-01326248

About the Role

Thermo Fisher Scientific is seeking Clinical Research Associates at various levels (CRA I, CRA II and Senior CRA) to support our PPD® clinical research portfolio. This role is integral to advancing high-quality clinical trials, ensuring compliance, and enabling the delivery of life-changing therapies across global markets.

As part of a leading global Contract Research Organization (CRO), you will contribute to end-to-end clinical trial execution — from site initiation and monitoring to study closeout — ensuring accuracy, audit readiness, and regulatory compliance.

Key Responsibilities

  • Perform and coordinate all on-site and remote clinical monitoring activities.

  • Assess protocol adherence, regulatory compliance, and data accuracy across investigative sites.

  • Conduct SDR, SDV and CRF reviews to ensure high-quality data collection.

  • Execute risk-based monitoring strategies using root cause analysis and problem-solving techniques to address site-level issues.

  • Maintain ongoing communication with investigative sites to ensure timely issue resolution.

  • Review investigational product inventory and ensure documentation accuracy.

  • Prepare comprehensive monitoring reports and documentation according to organizational standards.

  • Escalate critical issues to clinical management and manage resolution efficiently.

  • Assist in investigator identification and feasibility assessments for new studies.

  • Support site initiation, routine monitoring, and study closeout activities in compliance with ICH-GCP and local regulations.

  • Ensure essential documentation completeness and accurate system updates (e.g., CTMS).

  • Participate in investigator meetings and cross-functional collaboration.

  • Support process improvement initiatives and contribute to project-related documentation.

  • Maintain timely completion of administrative tasks such as timesheets and expense reports.

Role Complexity & Work Style

  • Works on routine to moderately complex tasks following established procedures.

  • Develops working knowledge of protocols, regulatory guidelines, and sponsor-specific requirements.

  • Receives detailed instruction initially; progresses to more independent decision-making based on experience.

Required Qualifications

  • Bachelor's degree in Life Sciences, Pharmacy, Nursing, or an equivalent health-related field.

  • Minimum 2+ years of on-site clinical research monitoring experience (for CRA I/II).

  • Demonstrated understanding of ICH-GCP guidelines and clinical research regulations.

  • Strong knowledge of medical terminology and therapeutic areas.

  • Proficient in risk-based monitoring concepts and documentation practices.

  • Excellent communication skills, both written and verbal.

  • Strong organizational skills, attention to detail, and ability to manage multiple priorities.

  • Ability to work independently or in a team environment.

  • Strong interpersonal and site relationship-building abilities.

  • Proficiency in Microsoft Office and ability to learn clinical research systems.

  • Valid driver’s license (as applicable) and ability to travel as required.

Preferred Skills

  • Critical thinking and root cause analysis capability.

  • Experience managing multiple monitoring environments (FSO, FSP, government studies).

  • Strong presentation and reporting skills.

Work Environment

  • Ability to communicate effectively with diverse teams and site personnel.

  • Must be able to work extended hours in office or field settings as required.

  • Ability to operate standard office and clinical research tools with proficiency.

  • Ability to manage workload under pressure and meet strict timelines.

  • May involve exposure to healthcare or laboratory environments.

Why Join Thermo Fisher Scientific?

Joining our Clinical Operations team provides an opportunity to support global clinical trials across 100+ countries. You will play a vital role in advancing scientific research, improving patient outcomes, and contributing to high-impact healthcare innovation. We offer a collaborative environment, career development support, and the chance to make a measurable difference in global health.