Job Details
Qualifications: Must be a licensed RN in the state of Georgia. Must have at least 2 years of clinical research experience within oncology, cardiology and/or neurology studies.
Responsibilities:
- Coordinates all facets of patient involvement in clinical trials.
- Conducts all aspects of clinical trial, including consenting, using Good Clinical Practice, FDA, and Institutional guidelines.
- Reviews patient chart for eligibility requirements and enrolls patient according to protocol guidelines.
- Communicates with physician/office staff regarding scheduling protocol specific requirements.
- Attends patient visits and gathers protocol-specific information when required.
- Communicates drug doses, protocol requirements and modifications to physician and office staff as appropriate.
- Coordinates disbursement of protocol provided drug therapy.
- Ensures that Investigation Product chain-of-custody practices are instituted and documented.
- Maintains accurate records for patients enrolled on clinical trials.
- Communicates effectively with Research Assistants and other research staff.
- Gathers appropriate source documentation.
- Submits required documentation within designated time frame.
- Provides proper documentation of eligibility, treatment and follow-up requirements.
- Provides accurate research information to physicians and sponsors.
- Maintains a current chart on each protocol patient.
- Enters patient visits into clinical trial database. Ensures regulatory guidelines are followed.
- Prepares research charts for monitoring visits and audits and assists with visits as required.
- Follows guidelines and timelines for reporting Adverse Events and Deviations.
- Maintains current protocol with revisions, amendments and current IRB approved informed consent.
- Ensures clinical trial and sponsor-required training is completed.
- Ensures that all training related to start-up of a clinical trial is accomplished, including attending Investigator Meetings when required.
- Ensures that ongoing training during the course of a clinical trial is completed.
- Facilitates ongoing training for other team members, including investigators.
- Maintains current Human Research Participant Protection and Hazardous Material training.
- Assists with other departmental functions.
- Attends committee meetings as required.
- Attends functional team meetings and disseminates information.
- Assists with regulatory and billing functions, when required.
- Responsible for additional projects, as directed by the manager.