Our clinical-stage startup medical device company is executing two clinical studies to support a panel-track PMA device treatment for uncontrolled hypertension. The Clinical Research Associate will assist in executing these two randomized, double-blinded studies in collaboration with the Sr. Clinical Program Manager and Chief Clinical Officer. The CRA will work with CROs to support the PMA approval of the Class III device and execution of the clinical study.
Your role with the company:
Site support for the enrollment and management of study subjects, including study materials, and the collection and management of regulatory documentation. Run and coordinate payments, device reconciliation, and study coordinator patient management metrics. The CRA will also support data management and committee work (DSMB, CEC). The role may also include annual reporting and other study related activities.
Desired Profile:
*2+ years as a Clinical Research Coordinator or Associate at a smaller medical device company.
*Experience working under little direction and excited to wear multiple hats.
*Must live in the Twin Cities and be available to meet in-person from time to time.
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