The Research Coordinator Ioversees the overall daily study activities and clinic operations, as well asassist in recruitment and retention of study participants, collect data,perform study procedures and assessments, review participant records andmonitor patient safety as well as assessments of adverse events. This positiontrains study personnel, documents data, performs quality control, and maintainsregulatory documents, such as Institutional Review Board (IRB), GCRC, NIH andother agencies involved in the study. This position serves in a leading role inrecruitment drives, conduct of various interventions, scheduling of prospectivesubjects, specimen handling, processing and data entry. The ResearchCoordinator supervises Endocrinology Clinical Research Unit (ECRU) staff aswell as coordinates the activities of the research studies according toprotocol. Additionally, the research coordinator performs outcomes assessments,coordinate visits to the ECRU by enrolled participants, coordinate thescheduled interventions, and track and enter laboratory and other datacollected from study subjects into the study database. This position maintainsthe required documentation by study sponsors, UTHSC IRB, FDA, and otherregulatory agencies in a timely manner.
Ensures participants fully understand the purpose, goals, requirements of the study, and eligibility status, as well as supervise the MRU staff.
Organizes, assists, and performs screening and follow-up procedures; Direct patient care, consenting process, visits including blood draws with enrolled participants, at the UTHSC in compliance with Studies Protocols.
Initiates and maintains the follow up schedule visits with a case load of study participants and schedule any additional testing schedules for the participants
Communicates with participants and Primary Care Physicians regarding results of tests obtained during the screening visit, study visits, according to HIPPA guidelines.
Evaluates the clinical status of the subjects for eligibility and throughout the follow-up phase of the study protocols.
Coordinates communication with Institutional Review Board, Research Administration and Department of Finance regarding the operation/safety and financial aspects of the studies
Obtains and maintains studies IRB approvals, including protocols revisions; report any adverse events to Data Safety Monitoring Board and IRB as required.
Organizes staff meetings and meet with Principal Investigator and Co-investigators regularly to review study progress and to correct data edits/queries.
Utilizes available computer programs in developing and maintaining participant data in order to support the effectiveness of communication and study management.
Maintains and ensures studies certification requirements and necessary study personnel.
Attends appropriate lectures, conferences, and training concerning IRB issues and HIPPA regulations.
Assists the Principal Investigator to developing the clinical data to be published related to the ongoing studies. Assists the Principal Investigator in the attendance of the research teleconferences.
Performs other duties as assigned.
Internal Number: 174406
The mission of the University of Tennessee Health Science Center is to bring the benefits of the health sciences to the achievement and maintenance of human health, with a focus on the citizens of Tennessee and the region, by pursuing an integrated program of education, research, clinical care, and public service.