Join Cedars-Sinai and become part of a team that is at the forefront of medical advancements. Work alongside physician-scientists and researchers who are making life-saving medical and scientific breakthroughs. Our team of researchers develop some of the most advanced clinical trials in the world. Here, you will be a part of leading-edge cancer research history that improves and enhances our patients' treatment options, one trial at a time.
The National Clinical Trials Network (NCTN) Program Coordinator will be responsible for administration of the NCTN clinical research program under the direct supervision of the Cancer Clinical Trials Office Associate Director. In addition, the NCTN Program Coordinator will serve as the subject expert for all NCTN studies being conducted through Cedars Sinai CCTO and our affiliates. Participate in conference calls and training activities. Will perform oversight, including tracking and monitoring of the status of the NCTN study portfolio through data gathering from various systems (e.g., OnCore, CIRB IRB Manager, CTSU, Medidata)
The NCTN Program Coordinator, will also be responsible for the following duties and responsibilities:
Serve as liaison between Cedars Sinai and the NCI and national groups, sharing information as pertinent with key stakeholders, responding to questions, and facilitating problem resolution.
Manage and maintain all membership/roster and access privileges for Cedar Sinai Cancer faculty and staff including NCI memberships for new and renewing members and access management to all NCTN systems (e.g., NCTN group rosters, CIRB IRB Manager, CTSU).
Maintain familiarity with NIH forms and requirements. Provide ongoing information concerning changes in federal policy, institutional and divisional initiatives, etc to relevant department staff and grant investigators.
Central management and distribution of funding for cooperative group clinical trials including monitoring and reconciling expenditures.
Monitoring Institutional Performance Review reports to ensure site compliance, including internal monitoring of data quality and timeliness for NCTN trials. This includes running query reports and data submission timeliness reports and disseminate to appropriate staff. Monitor data submission for accuracy, completion and query resolution and audit patient registration forms.
Produce regular reports to inform investigators current accrual data and credits.
Facilitate cooperative group audits, managing timelines and coordination of audits. Assist affiliates with their audits (on-site for audits or audit preparation). Coordinate and submit audit responses and corrective action plans.
Interface with pharmacy, clinical and regulatory staff to ensure coordination.
Provide training for employees on NCTN processes and document training of new employees on NCTN trials. Identify user needs and provide re-training as needed.
Helps foster a collaborative and positive relationship building dynamic with internal staff and external parties. May be responsible for providing any applicable education, training, on-boarding and/or mentorship pertaining to program.
Participate and may assist in tracking of NTCN payments.
Ensures the research protocols are approved by the Institutional Review Board and followed as written.
May assist with grant renewals or applications as necessary.
Bachelor's Degree Health care, Business Administration, Management or related field, preferred
3 years or greater of clinical research administration experience, required
3 years or greater of experience coordinating/leading NCTN trials, preferred
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