Clinical Research Associate II - Metabolic (US,
About The Position
Worldwide Clinical Trials is hiring a home-based Clinical Research Associate II to support clinical studies at investigative sites across the Central / West Coast of the United States. Candidates must reside within the territory and will travel primarily regionally, approximately 8–10 days per month, with occasional travel to other locations as needed. The role supports study execution from site qualification through closeout, with a focus on quality, patient safety, regulatory compliance, reliable data, and site performance. The CRA II works with investigative sites, study teams, and sponsors, providing monitoring, site management, training, guidance, and oversight throughout the clinical trial lifecycle.
Requirements
- Bachelor's degree or a nursing degree.
- At least 3 years of experience as a regional, traveling Clinical Research Associate.
- Experience monitoring cardiometabolic and hypertension clinical trials.
- Ability to travel within the specified region, approximately 8–10 days per month.
- Strong knowledge of clinical trial processes, site management, and regulatory requirements.
Nice To Haves
- Experience in full-service monitoring.
Responsibilities
- Manage clinical research activities at investigative sites participating in Worldwide clinical studies.
- Identify and assess potential research sites to support successful study execution.
- Coordinate study start-up activities, including collecting regulatory documentation and supporting contract and budget processes.
- Conduct Pre-Site Selection Visits (PSSVs), Study Initiation Visits (SIVs), Interim Monitoring Visits (IMVs), and Closeout Visits (COVs).
- Train site personnel on protocol requirements, data collection processes, and safety reporting expectations.
- Monitor site performance and provide ongoing support during study maintenance activities.
- Ensure compliance with informed consent requirements, safety reporting obligations, and applicable regulatory standards.
- Partner with sites and study teams to support data quality, participant safety, and study success.
- Support site closeout activities and ensure study requirements are completed at the conclusion of the trial.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
