Experienced Clinical Research Associate

3 weeks ago

Shell Rock Iowa, United States Medpace, Inc. Full time
Job Summary:

Medpace, a leading full-service clinical contract research organization (CRO), is seeking an experienced Clinical Research Associate to join our PACE (Professionals Achieving CRA Excellence) Training Program. As a Clinical Research Associate, you will play a critical role in the success of our clinical trials, working closely with investigators, site staff, and other stakeholders to ensure the highest quality data collection and compliance with regulatory requirements.

Key Responsibilities:
  • Conduct qualification, initiation, monitoring, and closeout visits for research sites in compliance with the approved protocol.
  • Communicate effectively with 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.
  • Verify 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 offer suggestions for improvement.
  • Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance.
Requirements:
  • Minimum of a bachelor's degree in a health or life science-related field.
  • At least 1.5 to 5 years of experience in clinical monitoring.
  • Willing to travel approximately 60-80% nationally.
  • Familiarity with Microsoft Office.
  • Strong communication and presentation skills.
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. Our mission is to accelerate the global development of safe and effective medical therapeutics through our 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 over 5,000 people across 40+ countries.

Why Medpace?

At Medpace, we are committed to making a difference in the lives of patients and families affected by disease. Our team is passionate about delivering high-quality clinical research services that accelerate the development of safe and effective medical therapeutics. We offer a dynamic work environment, competitive compensation and benefits package, and opportunities for professional growth and development.

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