Clinical Research Associate responsible for site qualification, monitoring, and close‑out visits, ensuring compliance with GCP, ICH guidelines and regulatory requirements.
Responsibilities
Conduct site qualification, initiation, monitoring, and close‑out visits
Ensure investigational sites maintain high standards of patient safety, data integrity, protocol compliance, and study quality
Build and maintain effective relationships with investigators and site personnel
Monitor study progress, including regulatory documentation, patient recruitment and enrollment, data query resolution, and site performance metrics
Collaborate with sites to implement and optimize patient recruitment and retention strategies
Requirements
University degree in Life Sciences, Health Sciences, Nursing, Pharmacy, or a related discipline, or equivalent combination of education and experience
Nice to have: sponsor‑dedicated or CFSP environment experience
Nice to have: patient recruitment and study start‑up activities
Support the Clinical Trial Unit in conducting NIH and industry-sponsored clinical trials, coordinating study visits, managing documentation, and assisting with regulatory and financial oversight.
Compensation
Pay Range Minimum: $45,144.00 annual
Pay Range Maximum: $50,736.00 annual
Responsibilities
Provide general research support and assistance to the UW Cardiology Clinical Trials Unit research team
Work independently on multiple research projects with reduced oversight
Collaborate with Research Coordinators, Administrative and Regulatory teams, health care teams, research participants, and other groups
Assist with study participant and visit support, including laboratory requisition, kit assembly, and scheduling
Maintain study documents, records, and inventory
Requirements
Two years of college-level coursework in a relevant academic area and one year of appropriate experience
Senior Clinical Trial Associate responsible for managing clinical trial activities, documentation, vendor coordination, and ensuring compliance with GCP and regulatory requirements.
Responsibilities
Independently manage assigned clinical trial activities and operational workstreams in compliance with study protocols, SOPs, GCP, and applicable regulations.
Oversee collection, review, filing, and reconciliation of essential study documentation, ensuring Trial Master File (TMF) completeness and inspection readiness.
Manage preparation, maintenance, and reconciliation of Investigator Site Files (ISFs).
Develop and maintain study trackers, timelines, and metrics to monitor enrollment, site activities, milestones, and deliverables.
Independently manage assigned vendors and workstreams, including central laboratory activities, study supplies, and vendor deliverables.
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