Under the supervision of the Coordinating Center Manager within the Clinical Trials Shared Recourses Coordinating Center, the RSC II supports the clinical research efforts of the Vanderbilt-Ingram Cancer Center by providing oversight and project management for participating sites of our Investigator Initiated Trials, in accordance with human subject federal regulations, internal standard operating procedures (SOPs), and Medical Center policies and procedures.

The NCI-designated Vanderbilt-Ingram Cancer Center (VICC) is a campus-wide multidisciplinary matrix organization whose goal is to promote and enhance cancer-relevant research and patient care. VICC provides research resources to its engaged faculty and offers multidisciplinary cancer care to its patients.

Responsibilities related to project coordination activities include independently managing start-up activities at the sponsor level, inclusive but not limited to, finalizing protocols for sponsor-investigators, submitting to internal and external committees (Food and Drug Administration [FDA], Scientific Review Committee [SRC], etc.) and funders. The setup and activation of outside vendors such as drug-depots and laboratories.

Additionally, the incumbent will be responsible for managing all components of the multi-site protocols. S/he will be responsible for developing protocol specific multi-site processes, checklists and templates for both standardization and ensure compliance with federal, state, and university regulations for the management and coordination for all investigator-initiated trials with sub-sites in collaboration with the Coordinating Center Manager.

In addition, the RSC II serves as the liaison to investigators, funders, governing agencies and facilitates transmission of verbal and written communication to pharmaceutical companies and other research entities as needed. The incumbent is also responsible for maintaining communication with all elements of a multi-level research network, including attending Disease Team Business Meetings, interacting with funding agencies including National Cancer Institute, and compliance and regulatory groups such as the Food and Drug Administration (FDA).

The incumbent must accurately maintain regulatory information in the clinical trial management system (OnCore) and adhere to institutional policies and external Cancer Center Support Grant guidelines for reporting to the National Cancer Institute (NCI).