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Clinical Research Associate (Cra)

2-5 years
Not Disclosed
10 Sept. 22, 2025
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

Job Title: Clinical Research Associate (CRA)

Locations: Europe, Middle East, Africa, Latin America & Asia Pacific (specific country not listed)
Employment Type: Regular / Full-time
Requisition ID: R363606
Job Posting End Date: 31/10/2025


Company Overview

Merck & Co., Inc., Rahway, NJ, USA (also known as Merck Sharp & Dohme LLC) is a global biopharmaceutical company focused on advancing healthcare through innovative research and clinical development.

Note for Search Firms:

  • Unsolicited CVs without a valid written search agreement will be considered company property.

  • No fee will be paid for hires resulting from unsolicited referrals.


Role Overview

The CRA is accountable for performance, compliance, and site management for assigned clinical study protocols in a country. Reporting to the CRA-Manager, the CRA ensures adherence to ICH/GCP, local regulations, company policies, quality standards, and adverse event reporting requirements. The CRA acts as the primary site contact and develops strong site relationships while expanding clinical research capabilities.


Key Responsibilities

  • Develop and maintain strong relationships with study sites throughout all trial phases.

  • Conduct clinical study site management/monitoring in compliance with ICH-GCP, Sponsor SOPs, local laws, protocol, and site monitoring plans.

  • Gain in-depth understanding of study protocols and related procedures.

  • Coordinate with sponsor roles to achieve Site Ready status.

  • Participate in site selection and validation activities.

  • Perform on-site and remote monitoring, ensuring:

    • Accurate, complete, and unbiased site data

    • Protection of subjects’ rights, safety, and well-being

  • Conduct site visits: validation, initiation, monitoring, and close-out. Document visit and non-visit interactions accurately and timely.

  • Collect, review, and monitor regulatory documentation for study start-up, maintenance, and close-out.

  • Communicate with investigators and site staff on protocol conduct, recruitment, retention, deviations, audits, and site performance.

  • Identify, assess, and resolve site performance, quality, or compliance issues; escalate per CRA Escalation Pathway.

  • Collaborate with GCTO operations, finance, regulatory affairs, pharmacovigilance, legal, vendors, IRBs/IECs, and regulatory authorities.

  • Maintain documentation in CTMS, eTMF, and other relevant systems.

  • Act as process Subject Matter Expert (SME), mentor, and share best practices.

  • Support or lead audits/inspections as needed.

  • Perform co-monitoring visits as required.

  • Contribute to identification and development of new potential sites in line with country strategy.


Qualifications & Experience

Education:

  • Associate's degree / certificate in scientific/healthcare discipline + ≥5 years healthcare experience (≥2 years direct site management in bio/pharma/CRO)
    OR

  • Bachelor’s degree or higher + ≥2 years direct site management experience in bio/pharma/CRO

Core Competencies:

  • Fluent in local language(s) and English (verbal and written)

  • Strong knowledge of clinical research, trial phases, ICH/GCP, local and global clinical research guidelines

  • Hands-on knowledge of Good Documentation Practices

  • Proven site management skills, including site performance and patient recruitment

  • Strong analytical skills for data interpretation and decision-making

  • IT proficiency: MS Office and various clinical IT applications (computer, tablet, mobile)

  • Root cause analysis and implementation of corrective/preventive actions

Behavioral Competencies:

  • Effective time management, organizational, and interpersonal skills

  • Independent judgment and problem-solving

  • Ability to manage multiple protocols, sites, and therapy areas simultaneously

  • Accountability, urgency, and priority-setting skills

  • Positive and growth mindset, professional demeanor

  • Works effectively in a multicultural matrix environment

  • Commitment to customer focus, high-quality work, and compliance


Skills Required

  • Accountability, Adaptability, Adverse Event Reporting Systems

  • Clinical Research Coordination and Methods

  • Clinical Study Management and Monitoring

  • Protocol Adherence, Regulatory Compliance

  • Data Analysis and Reporting

  • Training Team Members

  • Good Clinical Data Management Practice (GCDMP), GCP

Preferred Skills: Not specified


Travel & Relocation

  • Not specified

  • Flexible work arrangements: Not applicable

  • VISA sponsorship: Not specified


Additional Notes

  • Valid driving license and handling of hazardous materials: Not specified