Clinical Coordinator

University of Tennessee•Memphis, TN

11d

About The Position

Under the direction of the medical director and director of research, the Clinical Coordinator promotes good clinical practices on behalf of plastic surgery clinical trials by possessing in-depth knowledge of federal regulations.

Requirements

Registered Nurse. ( TRANSCRIPT REQUIRED)
Two (2) years of nursing or medical care in a clinical setting, in which one (1) is within a research environment; OR Master’s Degree in lieu of experience; OR a combination of college course work and work experience to equal six (6) years.
R.N. or B.S.N.
Current TN Registered Nurse License required.
Thorough understanding and knowledge of the research process and terminology.
Knowledge of the specialty under investigation.
Management and organizational skills.
Instructing, monitoring, data management, and critical thinking skills.

Responsibilities

Assists with ensuring all ongoing or anticipated clinical studies and related activities are performed according to federal regulations, as well as university and sponsoring agency policies and procedures.
Reviews and develops a familiarity with the study protocols (i.e. study proceedings and timelines, inclusion and exclusion of criteria, confidentiality, etc.).
Assists the medical director with communicating study requirements to all individuals involved.
Screens subjects for eligibility.
Prepares study material, as requested.
Maintains regulatory documents, prepares protocols, handles consent forms for submission to the UT IRB Office for initial and ongoing reviews.
Ensures study participants are safe and fully informed.
Performs clinical workups and follow-ups with patients as indicated by study protocols.
Serves as clinical liaison between clinical studies and others involved in projects including patients, physicians, nurses, data collectors, and evaluators.
Maintains documents related to clinical trials and human participant protection.
Ensures compliance with protocol and regulatory requirements, manages patient protocol activities, assures patient safety, collects records, and maintains data and source documentation.
Assists the residents and fellows in the collection of data and manuscript preparation.
Performs other related duties as assigned.