JOB DESCRIPTION: Serves as a resource to and liaison between all sites for a specified specialty disease type. Meets with disease and research teams across all sites and facilitates regular communication to provide oversight and guidance in protocol implementation and adherence, recruitment methods, and to review study progress. Ensures compliance with institutional policies and good clinical practices. Streamlines activation timeline for new trials as well as ensuring standardization across sites.
Communicates with external referrals which includes communicating with interested individuals who email the CTO general email address seeking information about clinical trials as well as physician referrals and self-referrals. Identifies possible trials for which patients may qualify, and acts as the liaison between the patient, the nurse navigator, and WCI referrals, as needed.
Creates and maintains strong relationships with referring physicians. Facilitates educational visits to community clinics and health centers and collaborates with the Winship Community. Serves as a host for outreach events featuring clinical trials.
Works with investigators to determine if potential trials fit into current portfolio and meet the needs of the current patient population. Manages the trial flowsheet that outlines trials that are open to accrual for each disease site.
Manages the accrual across all sites, including oversight of approved accrual versus actual accrual.
Coordinates study start up with the sponsor, PI and research team, which includes budget development. Organizes site initiation visits to ensure attendance of all sites. Ensures that all personnel are properly trained in study procedures and protocol requirements.
Assists investigators with new IIT protocol development which includes reviewing and assessing new protocols for clarity, thoroughness, logistical feasibility, maintaining subject safety etc. If required, advises on appropriate staffing and resource needs.
Under the guidance of the Assistant Director of Clinical Research, communicates with internal departments, as needed, to contribute to the development of streamlined processes for conducting clinical trials at all sites which may include Medical Oncology, Radiation Oncology, Surgical Oncology, Tissue Procurement Services, etc.
Serves as primary and initial point person for trial assessment. Completes initial CRO and sponsor requests of site abilities (site qualification visits, contact information for all aspects - IDS, regulatory, lab, etc). Navigates trial activation in combination with regulatory staff including submissions to CTRC and WIRB (draft consent forms), oversight of contract and budget negotiations to facilitate completion, and oversight of trial activation steps (order creation, SIV scheduling, drug shipment, radiation safety review). Extends the reach of Emory as a site by attending scientific meetings, such as ASCO, to advocate for trials. Performs related responsibilities as required,
MINIMUM QUALIFICATIONS: Bachelor's degree in a scientific, health related or business administration program and five years of clinical research experience or an equivalent combination of education, training and experience. |
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