Experienced Clinical Research Associate (Home-Based, anywhere in Norway)

Experienced Clinical Research Associate (CRA) - join our growing team based in Norway! Medpace is growing quickly and we are seeking experienced Clinical Research Associates to join our team in Norway (candidates can be based anywhere in Norway ) . We are an innovative, scientifically oriented mid-sized CRO that is focused on full-service project work. Through fast PACE ® for experienced candidates, Training Program, you will receive customized, expedited training, and efficient onboarding to familiarize you with Medpace systems. The Clinical Research Associate at Medpace is offered the unique opportunity to be involved at every stage of the development of medical therapeutics, in different, including rare diseases, cell and gene therapy, areas. Our successful Clinical Research Associates possess varied backgrounds in the medical and related healthcare fields, including but not limited to; Registered Nurses, Dieticians, Pharmacists, Faculty of Science Graduates and Research Assistants. An extensive training program provides the platform to effectively and confidently carry out your duties, the Medpace unique way. WE OFFER THE FOLLOWING:

• Retain airline reward miles and hotel reward points;
• Home office furniture allowance, laptop, mobile phone with hotspot for internet access anywhere;
• In-house travel agents
• Opportunity for leadership positions/career advancement – Lead CRA, CRA Manager, Clinical Trial Manager, Training and Development Manager;
• Customized Fast PACE ® training program based on your experience, therapeutic background, and interest;
• User friendly CTMS with electronic submission and approval of monitoring visit reports;
• Ongoing therapeutic training by our in-house physicians who are medical and regulatory experts;
• Opportunities to work with international team of CRAs; and
• Many additional perks unmatched by other CROs!

Responsibilities

• Conduct qualification, initiation, monitoring, and closeout visits at research sites in compliance with the approved protocol;
• Communication with the medical site staff including coordinators, clinical research physicians, and their site staff;
• Verify adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff;
• Medical record and research source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP, and applicable regulatory requirements;
• On-site and virtual/remote monitoring activities with a risk-based monitoring approach (including centralized data review) through our integrated Clinical Trial Management System to identify site deviations/deficiencies and corrective/preventive actions to bring a site back into compliance and mitigate risks moving forward;
• Verification that the investigator is enrolling only eligible subjects;
• Regulatory document review;
• Medical device and/or investigational product/drug accountability and inventory;
• Verification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol;
• Assess the clinical research site’s patient recruitment and retention success and offering suggestions for improvement; and
• Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance.

Qualifications

• Clinical Research Associate Experience (minimum 18 months of independent monitoring);
• Ability to travel 60-70% to locations nationwide is required;
• Must have a minimum of a bachelor’s degree in a health or science related field;
• Proficient knowledge of Microsoft® Office;
• Fluency in local language and excellent English;
• Must be detail-oriented and efficient in time management.

Medpace Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 6,000 people across 50+ countries. Why Medpace? People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace Perks

• Flexible work environment
• Competitive compensation and benefits package
• Competitive PTO packages
• Structured career paths with opportunities for professional growth
• Company-sponsored employee appreciation events
• Employee health and wellness initiatives

Awards

• Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024
• Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility

What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

• Clinical Research Associate Experience (minimum 18 months of independent monitoring);
• Ability to travel 60-70% to locations nationwide is required;
• Must have a minimum of a bachelor’s degree in a health or science related field;
• Proficient knowledge of Microsoft® Office;
• Fluency in local language and excellent English;
• Must be detail-oriented and efficient in time management.
• Conduct qualification, initiation, monitoring, and closeout visits at research sites in compliance with the approved protocol;
• Communication with the medical site staff including coordinators, clinical research physicians, and their site staff;
• Verify adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff;
• Medical record and research source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP, and applicable regulatory requirements;
• On-site and virtual/remote monitoring activities with a risk-based monitoring approach (including centralized data review) through our integrated Clinical Trial Management System to identify site deviations/deficiencies and corrective/preventive actions to bring a site back into compliance and mitigate risks moving forward;
• Verification that the investigator is enrolling only eligible subjects;
• Regulatory document review;
• Medical device and/or investigational product/drug accountability and inventory;
• Verification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol;
• Assess the clinical research site’s patient recruitment and retention success and offering suggestions for improvement; and
• Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance.

Apply tot his job Apply To this Job