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Clinical Research Associate, Nashua, NH

Clinical Research Associate, Nashua, NH

Conformal Medical was started in 2016 to develop the next generation of left atrial appendage occlusion implants used to prevent strokes in patients with Atrial Fibrillation (AFib). The CLAAS® System is an innovative technology that simplifies the procedure, improves the patient experience, and may improve outcomes. The company has completed first-in-human trials and is preparing for US pivotal clinical trials.

The Clinical Research Associate is a key member of the clinical affairs team and is responsible for the day-to-day management of clinical trial execution. The individual will also interface with the internal Conformal Regulatory, Quality, and Engineering teams to ensure a fully integrated multi-functional team is supporting the clinical trials.

Responsibilities
Provides operational support of clinical trial sites
Performs study protocol training to investigators and study staff team
Conducts and/or supports qualification, site initiation, interim and close-out visits
Supports enrollment strategy (i.e. develop advertising materials)
Supports data cleaning efforts through EDC query and data review
Coordinates shipment of investigational product
Submits study documents to Institutional Review Boards
Attends study team meetings and maintains meeting agenda, minutes
Supports review of clinical trial agreements and vendor agreements
Supports management of investigational site invoice processing
Assists with the review and maintenance of departmental SOPs
Supports the maintenance of the Trial Master File documents

Qualifications
A minimum of 5 years of medical device Clinical Affairs experience.
A history of site management experience is a must
BS degree in a technical discipline (eg biology, chemistry, engineering).
Experience in Microsoft Office
Experience with electronic database capture (EDC) platforms
Good communication with all levels of the company, hospitals, and physicians.
Travel 75%

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