Point person for the facilitation of Clinical Trial Testing; bridges the sponsor and trial execution by managing client relationships and overseeing trial progress.
• Manage all aspects of assigned trials under your purview with direction from the lead Project Manager.
• Communicate with clinical and regulatory affairs and translate information effectively. This includes all matters; technical, facilitation of workflow, testing sites and customer relations.
• Maintain up to date and accurate logs reflecting testing status.
• Provide metrics to the site, customer or sponsor as requested.
• Resolve issues as they arise. Report critical issues to site leadership.
• Provide updates as requested.
• Develop SOPs supporting clinical trial testing as required.
• Maintain Study Binders/Trial Master File (TMF) as required per GCP.
• Perform Quality checks on all deliverables to customers. Partner with other employees to ensure second QC checks when required.
• Training other personnel as required.
Qualifications and Experiences:
• Associate or bachelor's degree (AA or BS).
• Two years’ experience and/or training in related field such as in a Contract Research Organization, University or Medical setting, or other equivalent experience.
• Experience working in regulated environments and familiarity with CAP/CLIA/CDx regulatory compliance and quality assurance standards.
• Minimum of 2 years Study Coordinator or Clinical Research or Trial experience required.
Compensation
$25.00/hr - $27.00/hr Exact compensation may vary based on several factors, including skills, experience, and education. Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.
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