Sr Clinical Research Associate
Clinical Research Associate/CRA/Sr CRA/Clinical Research/Clinical Monitoring Senior Clinical Research Associate (Sr CRA) plans and manages the site management and oversight aspects of assigned clinical trial(s)/programs. The Sr CRA will work collaboratively with the Clinical Program Manager counterparts and with supervision from the Line Manager (LM) on timelines, budgets, resources, vendors and key project deliverables. The key responsibilities of this Sr CRA will include: -Overall clinical study site management (study start-up through closure) -Vendor management as it pertains to site activities -Quality control of site management and clinical monitoring activities -Provide site management and monitoring expertise to the clinical program manager and input to key documents, (e.g. enrolment and vendor oversight plans, etc.), and recruitment strategies, as well as contingency strategies for managing risks to clinical operations. -Provide input into non-project work, training activities, and development of procedures as needed. Participate in corporate initiatives as requested. -Development of Master Study ICF template, Monitoring Plan and other critical study documents and templates as appropriate. -Work closely with Clinical Trial Team to ensure timely resolution of site management and monitoring issues -Proactively identify and resolve study site management and monitoring issues. -Contribute to the selection and negotiation with clinical study sites, Clinical Research Organisations (CROs), and other external vendors. -Participate in protocol review as requested. -Responsible for preparation of materials for Investigator meetings, Site Monitor training, and other meetings as required. - Create and deliver presentations pertaining to site focused information. Aerotek is a division of Allegis Group Ltd. Allegis Group is an Employment Business and Agency.
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