Requisition ID 26533BR
Title Lead Clinical Research Associate (CRA)
Job Category Clinical Trial Management
Job Description PURPOSE:
Responsible for the performance of assigned sites in accordance with Good Clinical Practice (GCP), ICH guidelines and federal regulations. Responsible for operational aspects of planning and management of site performance in accordance with departmental productivity expectations. Acts as primary liaison between In-House CRAs, Field Based CRAs and the PM for assigned sites. Close collaboration with other members within Clinical Trial Management (CTM) and with various representatives within CMR.
Reports to an Associate Director/Senior Manager/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.
COORDINATION / COMMUNICATION, ADMINISTRATION AND PERSONNEL DEVELOPMENT:
- Ensure compliance with the application and communication of all Novo Nordisk® policies, procedures and fundamentals.
- May participate in continuous improvement processes for function.
- Accountable for the quality of site performance for assigned sites. Responsible for collaborating 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.
- Accountable for providing oversight of the entire site management process for the life cycle of the assigned sites, 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.
- Determine and drive the SSV process (track and report progress, review data) ensuring that all sites are selected and supplies provided in accordance with study start expectations.
- Develop and may finalize the country recruitment/retention strategy in collaboration with the Project Manager (PM). Identify potential risks to the enrolment targets based on feasibility analysis in collaboration with the PM.
- Develop Informed Consent (ICF) in accordance with expectations of NNI.
- Develop SSV/SIV and other training tools and training materials in support of the project for the project assigned CRAs...cont.