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Experienced Clinical Research Associate

1-3 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: Croatia
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 Croatia 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 Croatia 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 in compliance with approved protocols.
  • Communicate effectively with medical site staff, including coordinators and clinical research physicians.
  • Verify investigator qualifications, training, and available resources (facilities, laboratories, equipment, staff).

Regulatory & Compliance

  • Perform medical record and research source documentation verification against case report form (CRF) data.
  • Ensure good documentation practices and report protocol deviations per SOPs, GCP, and regulatory requirements.
  • Verify that investigators enroll only eligible subjects in clinical trials.
  • Conduct regulatory document review to ensure adherence to protocols.

Drug & Safety Management

  • Perform medical device and/or investigational product accountability and inventory checks.
  • Verify and review adverse events (AE), serious adverse events (SAE), concomitant medications, and corresponding illnesses to confirm accurate data reporting.
  • Assess patient recruitment and retention success and provide suggestions for improvement.

Reporting & Documentation

  • Complete monitoring reports and follow-up letters, summarizing findings, deviations, deficiencies, and recommended corrective actions.

QUALIFICATIONS & EXPERIENCE

Education:

  • Bachelor’s degree (or higher) in a health-related field, MD, or equivalent.

Experience:

  • Minimum of 1 year of independent CRA monitoring experience.

Technical & Regulatory Knowledge:

  • Broad knowledge of medical terminology and clinical patient management.
  • Basic understanding of drug therapy techniques and clinical research methodologies.
  • Strong knowledge of local regulations and ICH GCP guidelines.

Soft Skills & Language Requirements:

  • Fluency in Croatian and English (verbal and written).
  • Excellent communication and time management skills.
  • Strong attention to detail and ability to work independently.
  • Valid driver’s license required.

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 Croatia, apply now to join Medpace’s growing team!