Clinical Research Associate

Clinical Research Associates conduct studies to examine the safety and efficacy of new drugs in human patients. These studies are known as clinical trials.

Fast Facts & Skills

Details

Education & Training: 

Position requirements range from high school diploma to a 4-year degree, however most employers prefer a two-year degree in a scientific discipline, RN or BSN degree or equivalent; 2 years of previous clinical experience or nursing experience is often required and previous clinical research experience is preferred. This is an ideal position for people who are transitioning from a nursing career.

Common requirements and abilities:

  • A Bachelors degree
  • Highly organized
  • Remote monitoring visits
  • Excellent verbal and written communication skills
  • Excellent organizational, multi-tasking and time management skills
  • Working knowledge of International Conference on Harmonization Good Clinical Practice guidelines (ICH-GCP)
  • Experienced in Microsoft Office Products (Word, Excel, PowerPoint, SharePoint, Teams) and other clinical trial systems (e.g., CTMS, EDC and eTMF)
  • Ability to travel as required (50-75%)
 

Clinical Research Associates conduct studies to examine the safety and efficacy of new drugs in human patients. These studies are known as clinical trials. They follow GCPs (Good Clinical Practices) and ICH (Registration of Pharmaceuticals for Human Use) practices and help coordinate data management efforts. ICH is the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH)

Their work involves the management and oversight of clinical study sites to ensure data quality and patient safety in accordance with ICH-GCP guidelines, local regulations, and applicable SOPs.

Other names for this position are Clinical Operations Associate or Clinical Research Monitor. 

Clinical Research Associate’s provide administrative assistance in site selection, study implementation and ongoing coordination of study sites, either directly or via CROs (Clinical Research Organizations).

This job involves monitoring study sites, performing routine data collection from patients, verifying data sources, and reviewing regulatory documents/files to ensure that documents are in compliance with protocols, regulatory requirements, SOPs (standard operating procedures), and are aligned with the Monitoring Plan. Some clinical research associates assist in reviewing study protocols,  informed consent forms, and case report forms. They may also participate in developing monitoring plans, abstracts, presentations, manuscripts and clinical study reports under supervision. 

Where to Work and Learn

Example Employers: 

InnovATEBIO programs offer degrees, certificates, or teach skills in these related areas.

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