Oncology Research Coord I

Research:

1. 1. Organize, participate, and assist in the preparation of documents needed for the initiation, monitoring, internal and external auditing and study close out visits.
   2. Coordinates the conduct of oncology clinical trials.
   3. Completes and maintains the relevant research training to function in the role- including EPIC training, EPIC billing, CITI, GCP, and Specimen Handling.
   4. Completes and maintains the oncology study specific training required to work on assigned trials- not limited to electronic data bases, scan portals, lab portals, protocol training and amendment training.
   5. Active in planning and implementation of patient recruitment into studies; reviewing medical records of upcoming new and return patient clinic visits and discussing with investigators, reaching out to potential referring physicians, approaching potential subjects in the office or speaking to them by phone, asking pre-screening eligibility questions, etc. and document in the electronic medical record system, EPIC.
   6. Participate in clinic to explain the trial and provide informed consent to the patient and family, documenting the process in the patient’s electronic medical record system, EPIC.
   7. Develop, schedule and oversee subject visits and any necessary testing and appointment coverage according to protocol and in accordance with Good Clinical Practice (“GCP”) (e.g. scheduling subject visits within the appropriate window, ensuring all tests and assessments at each visit are performed, reporting adverse events and ensuring review and appropriate follow-up by investigator (documenting in EPIC any patient reported symptoms and forwarding to the appropriate clinical team), monitoring patient care and treatment side effects in concert with investigators, detailed documentation of study activities).
   8. Ensure drug accountability and appropriate diary completion. Ensure adequate drug supply and assist Pharmacist with ordering if needed.
   9. Monitor subjects per protocol requirements and ensure adherence to protocol.
   10.  Organize and maintain all documentation required by the sponsor or CRO per GCP - includes source documentation (including the electronic medical record system, EPIC), case report forms, and research charts.
   11.  Collect, review and report timely, valid, accurate study data. Obtain records required to complete case report forms. Maintain clinical trial databases by completing case report forms within 5 business days of subject visits and resolving data queries within 10 days of issuance. These timelines may be shortened during periods of data lock or in preparation for abstract/manuscript submission.