Clinical Research Coordinator
Company: University of Tennessee Medical Center
Posted on: June 10, 2021
Directs the conduct of 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
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.
Manages sponsor-initiated monitor visits, quality assurance
audits, other periodic reviews and data queries, providing
Identifies strategies to improve patient enrollment in research
protocols and works with the PI to develop and implement effective
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.
Performs intradepartmental patient chart audits.
Maintains appropriate inventory of study supplies, including
investigational product, in accordance with sponsor protocol and
policy and UTMC policy on IP/ID Accountability.
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.
- 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.
Bachelor's of Science - Nursing
RN license - Tennessee
Minimum 3 years clinical nursing experience
Keywords: University of Tennessee Medical Center, Knoxville , Clinical Research Coordinator, Other , Knoxville, Tennessee
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