RN Research Coordinator

Job Summary

The Research Coordinator has general responsibility for managing clinical trials for the Clinical Trials Office of the Well Star Health System. Duties include identifying potential study patients, ascertaining patient eligibility for clinical trials, coordinating, evaluating, and following patients in clinical trials, coordinating therapy initiation and continuation, taking call for issues related to clinical trials, completing and filing necessary forms with internal and external departments and agencies, and maintaining records for patients enrolled in clinical trials.

• Coordinate all facets of patient involvement in clinical trials.
• Conduct all aspects of clinical trial, including consenting, using Good Clinical Practice, FDA, and Institutional guidelines.
• Review patient chart for eligibility requirements and enroll patient according to protocol guidelines.
• Communicate with physician/office staff regarding scheduling protocol specific requirements.
• Attend patient visits and gather protocol-specific information when required.
• Communicate drug doses, protocol requirements and modifications to physician and office staff as appropriate.
• Coordinate dispensation of protocol provided drug therapy.
• Ensure that Investigation Product chain-of-custody practices are instituted and documented.
• Maintain accurate records for patients enrolled on clinical trials.
• Communicate effectively with Research Assistants and other research staff.
• Gather appropriate source documentation and submit required documentation within designated time frame.
• Provide proper documentation of eligibility, treatment and follow-up requirements.
• Provide accurate research information to physicians and sponsors.
• Maintain a current chart on each protocol patient and enter patient visits into clinical trial database.
• Ensure regulatory guidelines are followed.
• Prepare research charts for monitoring visits and audits and assist with visits as required.
• Follow guidelines and timelines for reporting Adverse Events and Deviations.
• Maintain current protocol with revisions, amendments and current IRB approved informed consent.
• Ensure clinical trial and sponsor-required training is completed.
• Ensure that all training related to start-up of a clinical trial is accomplished, including attending Investigator Meetings when required.
• Ensure that ongoing training during the course of a clinical trial is completed.
• Facilitate ongoing training for other team members, including investigators.
• Maintain current Human Research Participant Protection and Hazardous Material training.
• Assist with other departmental functions, including attending committee meetings, functional team meetings, regulatory and billing functions, and additional projects as directed by the manager.

• Graduate from an approved school of nursing.

• Reg Nurse (Single State) or RN - Multi-state Compact

• Minimum 5 years RN experience.
• Minimum 2 years Research experience.
• Hospital experience.
• Critical Care experience.

• Strong computer skills.
• Good oral and written communication skills.
• Excellent interpersonal and organization skills.