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Requisition ID 31694BR
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.
- Develop study tools for sites and CRA use.
- Ensure that monitoring visits are performed in accordance with protocol/SOP requirements and that these are tracked, including report status and sign off.
- Accountable for the quality of the trip report content and sign off timelines for all assigned sites.
- Facilitate the review of the Monitoring Guideline and ensure that a member of the CRA project team provides input.
- Generate potential site list from key stakeholders across CMR and drive site feasibility process.
- May provide review of eCRF.
- Provide review of protocol and protocol amendments.
- Responsible for the development of any mass site communication as appropriate.
- Responsible to develop and maintain the project Q and A documents.- Responsible to ensure internal productivity metrics, especially for trip report completion within the assigned timeframes and to the expectations of CTM.
- Review and enter all protocol deviations in collaboration with the CRAs.
- Review and provide input to the Trial Materials Manual and ensure distribution to assigned sites and project team members as appropriate (CRAs).
- May provide active mentorship of CTM staff to build talent across the department.
- May develop and maintain guidelines, training programs, policies and procedures for the functional locally.
- May support in the identification of training gaps within function, may support the development of training materials to meet that gap and then provision of training as required to improve core competency and skill set of the department.
- Accountable for the compliance and quality of CATS reporting.
- Active membership to local project teams, contributor to Clinical Team Unit (CTU) Meetings.
- Participates in cross-functional teams, locally, to assure timely attainment of project milestones.
- Responsible for conducting oneself in accordance with expectations as a project team member to ensure the success of a matrix management structure.
- Responsible for ensuring that the mandatory trial entries are made in IMPACT, NovoDOCs, iSITE, EDC administration and updates, and ensure CSIM entries and updates are made.
- Responsible for maintaining focus, locally, for specific project activities within CMR priorities.
- Attend relevant symposia, conferences and scientific meetings, as necessary
- Provide support and potential identification of training needs across CTM and may support the creation, development and potentially provide training support to meet those needs. This includes any lessons learned sharing across the project team members and/or CTM.
- Approximately 20% to 40% overnight travel to visit assigned sites.
- Office based in Princeton, NJ
KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
- A Bachelors’ degree (science-related discipline preferred).
- At least a minimum of 6-8 years of clinical trial experience within pharmaceutical, biotechnology or CRO and/or healthcare setting, of which 4 years must be where the previous roles were directly related to the management of site performance in accordance with clinical trial execution.
- A minimum of 12 months of site monitoring experience required.
- Demonstrated computer skills (MS Office, MS Project, PowerPoint).
- Demonstrates core understanding of medical terminology and clinical trial activities in relation to execution of a clinical development plan.
- Knowledge of GCP as relates to clinical trial management.
Department CMR - SITE MANAGEMENT (2)
Position Location US - Princeton, NJ
State/Provinces US - NJ
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