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Job Description

• 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.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to [email protected] learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.

Skills and Requirements

• Associates (AA or AS) degree.

• One or more years of 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 as a Study Coordinator, Clinical Researcher or Clinical Trial experience required.

• Strong understanding of regulatory compliance and HIPAA

• Knowledge of medical terminology

• Past experience as Project Manager, Project Coordinator, or Clinical Research Associate • Clinical laboratory experience working with samples

• Hands on experience with patients in clinical trials

Experience with Trial Master File or Clinical Study Management