Lead Clinical Research Associate Job - Princeton, NJ

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  • Published date: December 14, 2017
    • Princeton, New Jersey, United States

Purpose
Responsible for the performance of assigned sites within assigned trials in accordance with Good Clinical Practice (GCP), International Council of Harmonisation (ICH) guidelines, federal regulations and Standard Operating Procedure (SOPs). Responsible for operational aspects of planning, managing and execution of site performance in accordance with departmental productivity expectations. Acts as primary liaison between In-House Clinical Research Associate (CRAs), Field Based CRAs and the Project Manager (PM) for assigned trials. Close collaboration with other members within Clinical Trial Management (CTM) and with various representatives within Clinical Medical Regulatory (CMR).

Relationships
Reports to the Line of Business (LoB) manager of Site Management (SM) within CTM. Accountable for actively participating in multiple internal cross-functional teams locally to ensure the effective delivery of assigned project milestones. External relationships are with clinical investigators, Contract Research Organizations (CROs), and other clinical research vendors as needed to support business objectives for the department and/or function.

Essential Functions
Coordination/Communication, Administration & Personnel Development: Ensure compliance with the application and communication of all Novo Nordisk® policies, procedures and fundamentals.
Functional Support: Participates in continuous improvement processes for function.

Project Support: Accountable for providing oversight of the entire site management process for the life cycle of the assigned trial, with the development of essential documents and tracking of site performance metrics. Accountable for reviewing and approving all trip reports for assigned sites. Accountable for ensuring that any issues are escalated in accordance with the CTM escalation pathway to the PM. Accountable for the quality of site performance for assigned trial. Responsible to collaborate with the CRA to develop any Corrective Action Plan (CAP). Accountable for ensuring that the CAP is delivered and issues escalated to the PM in accordance with the CTM escalation pathway. Accountable to assist sites, internal staff and CRAs with the preparation for GCP audits, including file review according to the CTM Audit Management Plan. Determines and drives the SSV process (i.e., track and report progress, review data), ensuring that all sites are selected and supplies provided in accordance with study start...cont.

Learn more and apply online at http://www.hirelifescience.com/lead-clinical-research-associate-job/princeton-nj-11111-765490/?p=p&submission=2

Matthew Masterson
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