Coordinator

Position Summary:

Serves as the project coordinator on multiple clinical research studies for various sponsors including government agencies, cooperative groups, pharmaceutical companies, biotechnology companies, and/or medical device companies. May also serve as the coordinator for internal investigator initiated clinical research.

Must follow the study protocol as designed and written by the study sponsor adhering to Good Clinical Practice as defined by the U.S. Food and Drug Administration, as well as other appropriate regulatory agencies. Works with study investigators, Research nurses, supervisor, and other organization team members to address study-related issues. Back up other coordinators as needed.

Directs the conduct of Oncology clinical research studies in adherence to the research protocol and in compliance with FDA regulations and Good Clinical Practice (GCP).

Screens patient records, databases, physician referrals, physicians' schedules, etc., and rounds in Clinics checking with physicians to identify prospective candidates for research studies.

Discusses participation in clinical research studies with patients and obtains informed consent.

Participates in Pre-Study Site Visits, Site Initiation Visits, Investigators' Meetings, etc., for assigned clinical research trials and implements the trials according to schedules agreed between Sponsor and PI.

Completes study documentation, maintains patient research files and coordinates the collection of data according to the research protocol, operations manual, and case report form guidelines.

Monitors study participants' clinical status and reports adverse and serious adverse events to PI and Sponsor in accordance with the research protocol and Sponsor direction.

Performs and coordinates patient tests and procedures as outlined in the research protocol and reports findings to PI.

Maintains appropriate inventory of study supplies, including investigational product, in accordance with sponsor protocol and policy and UTMC policy on IP/ID Accountability.

Performs intradepartmental patient chart audits.

Participates in regularly scheduled meetings with Principal Investigator(s) to discuss clinical trials and patients.

Assists PI in communicating study requirements to all individuals involved in the study and provides appropriate training and study tools for study team members.

Identifies strategies to improve patient enrollment in research protocols and works with the PI to develop and implement effective recruitment strategies.

Manages sponsor-initiated monitor visits, quality assurance audits, other periodic reviews and data queries, providing information requested.

Attends all departmental, intraorganizational and Nurse Navigator meetings related to the patient population for assigned trials, as well as meetings for individual patients where plan of care is discussed.

Maintains current knowledge and training in the understanding and application of clinical practices necessary to treat the syndromes related to the clinical trial and disease state.

Maintains all licenses and certifications required to participate with and treat patients in clinical trials.

Position Qualification:

RN license - Tennessee

3-5 years clinical or research experience preferred.