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Experienced Clinical Research Associate

3-4 years
Not Disclosed
10 Feb. 12, 2025
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

Job Title: Experienced Clinical Research Associate

Location: Serbia
Department: Clinical Research Associate
Job Type: Full-time, Home-Based


ABOUT MEDPACE

Medpace is a full-service clinical contract research organization (CRO) providing Phase I-IV clinical development services to the biotechnology, pharmaceutical, and medical device industries.

Headquartered in Cincinnati, Ohio, Medpace operates in 40+ countries with over 5,000 employees. Our mission is to accelerate the global development of safe and effective medical therapeutics through a scientific and disciplined approach, leveraging local regulatory and therapeutic expertise in key therapeutic areas such as oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral, and anti-infective research.


JOB SUMMARY

Medpace is expanding its clinical activities in Serbia and is seeking full-time, home-based Clinical Research Associates (CRAs) to join the Clinical Monitoring team.

This role will be instrumental in growing the team in Serbia and supporting key clinical research projects. CRAs at Medpace are involved at every stage of the drug development process, providing unrivaled support to customers while advancing their careers in clinical research.

Note: Applications should be submitted in English.


KEY RESPONSIBILITIES

Site Management & Monitoring

  • Conduct qualification, initiation, monitoring, and closeout visits for research sites.
  • Communicate effectively with medical site staff, including coordinators and clinical research physicians.
  • Verify investigator qualifications, training, and site resources (facilities, laboratories, equipment, and staff).
  • Ensure medical record and research source documentation verification aligns with case report form (CRF) data.
  • Identify and communicate data entry errors, protocol deviations, and regulatory compliance issues.
  • Verify that only eligible subjects are enrolled.
  • Conduct regulatory document review.
  • Oversee medical device and/or investigational product/drug accountability and inventory.

Safety & Compliance

  • Monitor and review adverse events (AE), serious adverse events (SAE), concomitant medications, and corresponding illnesses.
  • Ensure accurate data reporting in accordance with clinical protocols.
  • Assess patient recruitment and retention strategies and provide recommendations for improvement.
  • Complete monitoring reports and follow-up letters, summarizing findings, deviations, deficiencies, and compliance actions.

QUALIFICATIONS & EXPERIENCE

Education:

  • Bachelor’s degree (or higher) in a health or life science-related field.

Experience:

  • Minimum of 3 years of experience as a CRA.

Technical & Regulatory Knowledge:

  • Proficiency in clinical patient management, protocol adherence, CRF preparation, and ISF documentation.
  • Familiarity with documentation requirements for competent authorities.
  • Strong knowledge of Microsoft® Office and general computer literacy.

Soft Skills & Language Requirements:

  • Fluency in Serbian and English (verbal and written).
  • Excellent communication, presentation, and time management skills.
  • Detail-oriented with strong organizational abilities.
  • Ability to travel 20-30% as required for site visits.

COMPENSATION & BENEFITS

Salary & Benefits:

  • Competitive salary based on experience.
  • Flexible work environment (home-based).
  • Comprehensive benefits package.

Perks & Growth Opportunities:

  • Structured career paths with opportunities for professional growth.
  • Company-sponsored employee appreciation events.
  • Employee health and wellness initiatives.
  • Competitive PTO package.

AWARDS & RECOGNITION

  • Forbes: America's Most Successful Midsize Companies (2021, 2022, 2023, 2024).
  • CRO Leadership AwardsLife Science Leader Magazine (Expertise, Quality, Capabilities, Reliability, Compatibility).

HOW TO APPLY

If you are an experienced Clinical Research Associate looking for an exciting opportunity in Serbia, apply now to join Medpace’s growing team!