In-House Clinical Research Associate II
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About The Position
The Clinical Research Associate (CRA) supports the Global Clinical Operations (GCO) Center of Excellence, conducting activities consistent with GCO's mission of building a world class shared clinical technology, process innovation and clinical operations team, in partnership with the company's divisions, through technology enablement, high-touch customer service, study acceleration, and high-quality data collection. Driving principles and behaviors for this role are caring, diversity, global collaboration, high performance, meaningful innovation, winning spirit. Through coordination with the Contract & Budget team, and collaboration with divisional and regional clinical teams, the CRA conducts clinical trial site start-up activities related to the preparation and approval of regulatory documents, ensuring they are conducted consistent with service level agreements, legal and regulatory standards, and applicable company policies and procedures. Specifically, these activities will include: IRB submissions and approvals, Site informed consent form (ICF) customizations & negotiations, and Essential regulatory document collection. The CRA also provides support in enrollment, follow-up, and closure of clinical trial activities.
