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Experienced Clinical Research Associate (Home-Based, Anywhere In Norway)

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 (Home-Based)

Location: Norway (Remote – Candidates can be based anywhere in Norway)
Department: Clinical Research Associate
Job Type: Full-time


ABOUT MEDPACE

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

With over 5,000 employees across 40+ countries, Medpace is dedicated to accelerating the global development of safe and effective medical therapeutics through a scientific and disciplined approach. Our local regulatory and therapeutic expertise spans across oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral, and anti-infective research.


JOB SUMMARY

Medpace is expanding its clinical activities in Norway and is looking for experienced Clinical Research Associates (CRAs) to join our team remotely from anywhere in Norway.

As part of our Clinical Monitoring team, CRAs at Medpace benefit from:

  • A customized Fast PACE® training program tailored to their experience, therapeutic background, and career interests.
  • An efficient onboarding process with comprehensive support.
  • Opportunities for career advancement into roles such as Lead CRA, CRA Manager, Clinical Trial Manager, or Training & Development Manager.

KEY RESPONSIBILITIES

Site Management & Monitoring

  • Conduct qualification, initiation, monitoring, and closeout visits at research sites in compliance with approved protocols.
  • Maintain effective communication with medical site staff, including coordinators and clinical research physicians.
  • Verify investigator qualifications, training, and available resources (facilities, laboratories, equipment, and staff).

Regulatory & Compliance

  • Perform medical record and source documentation verification against case report form (CRF) data.
  • Ensure adherence to good documentation practices, identify protocol deviations, and address compliance issues.
  • Conduct regulatory document review and ensure all necessary approvals are in place.

Risk-Based Monitoring & Virtual Oversight

  • Utilize on-site and remote monitoring approaches with risk-based monitoring methodologies.
  • Perform centralized data reviews using an integrated Clinical Trial Management System (CTMS).
  • Identify site deviations and deficiencies, implement corrective and preventive actions, and mitigate risks.

Drug & Safety Management

  • Conduct medical device and investigational product/drug 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:

  • Minimum Bachelor’s degree in a health or science-related field.

Experience:

  • Minimum of 18 months of independent CRA monitoring experience.

Technical & Regulatory Knowledge:

  • Proficient knowledge of Microsoft® Office.
  • Comprehensive understanding of local regulations, ICH GCP guidelines, and clinical research methodologies.

Soft Skills & Language Requirements:

  • Fluency in Norwegian and English (verbal and written).
  • Excellent communication, time management, and organizational skills.
  • Strong attention to detail and ability to work independently.

Travel Requirements:

  • Ability to travel 60-70% nationwide as required.

COMPENSATION & BENEFITS

Salary & Benefits:

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

Perks & Career Development:

  • Home office furniture allowance, laptop, and mobile phone (with hotspot for internet access anywhere).
  • Retain airline reward miles and hotel reward points.
  • In-house travel agents for travel support.
  • Ongoing therapeutic training provided by in-house medical and regulatory experts.
  • Opportunities for career progression into leadership roles.

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