Clinical Research Coordinator I - Gastrointestinal Surgery
Clinical Research Coord I
The Department of Surgery is seeking applicants for a Clinical Research Coordinator I to coordinate ongoing clinical research trials within the Division of Acute Care Surgery under the direction of the senior study coordinator. As part of an interdisciplinary health team, the incumbent will collaborate with other Clinical Research Coordinators, physicians, nurses, and other key personnel in the department and clinic to ensure compliance with protocol requirements and satisfactory care for enrolled patients. The incumbent will also assist in the development of protocol methodologies and data collection. Collecting blood draws from patients as needed will be required. Phlebotomy certification required within 6 months of hire.
- Coordination of Protocol Subjects & Data Collection, such as performing subject screening and consent for clinical protocols under the direction of the Principal Investigator (PI); serving as a patient resource and educator for information regarding the study or clinical symptoms; preparing and shipping central lab samples as per protocol requirements; Collecting blood draws from patients as needed will be required; Collecting baseline and follow-up data from medical records; scheduling and attending clinic appointments for patients as required by protocol; communicating with nursing staff and OR staff about patient care according to protocols; assisting with operating room protocol requirements where appropriate; recording patient symptoms and adverse events in conjunction with care providers; reporting and following up adverse events and serious adverse events, after discussion with Principal Investigator, to sponsor and Investigational Review Board as required by protocol.
- Research Support, such as: helps with protocol development and
protocol endpoints to ensure statistical and clinical relevance of
studies; assesses clinical needs by performing literature review
and discussion with faculty advisors within Division; prepares and
submits filings of protocols to Institutional Review Board and
Animal Care Committees as needed; designs Case Report Forms and
Source Documents for clinical protocols where required; work
alongside medical and scientific partners on grant development
projects. Maintains awareness of Good Laboratory Practices as
needed for preclinical studies within Division; work alongside
medical and scientific partners on manuscript preparation and
abstract submission for principal investigators; submits protocols
to the Office of Clinical research (OCR) and IRB offices to assure
compliance under the direction of the senior study coordinator;
organizes and maintains regulatory files for clinical studies
performed within Division; interacts with the Institutional Review
Board under direction of Principal Investigator for clinical
research protocols; assist lab manager and provide back-up support
in lab for processing samples as needed.
- Coordination of Protocol Compliance, such as: maintains
knowledge base of Good Clinical Practice Guidelines and Federal
Code of Regulations regarding clinical trial conduct; coordinates
and maintains HIPAA compliance for assigned studies; communicates
with interdisciplinary health team in care of patients involved in
research studies to ensure regulatory compliance; interacts with
local laboratories and diagnostic study centers to ensure clinical
protocol requirements are complete for studies; coordinates efforts
of Investigational Pharmacist and maintains site records for Good
Clinical Practice and sponsor guidelines.
- Tracking the type of study services performed to ensure that
they are compensated appropriately, such as: performing billing
review for study subjects and dispensing human subjects’ payments
to study participants.
- Other duties as assigned. Maintains working knowledge of computing skills: Microsoft Word for Windows, PowerPoint, Access, and Excel. Facilitates efforts for ongoing database(s) within the Division.
Associate's degree or an allied health professional degree in an appropriate area and one year of relevant experience; or an equivalent combination of education and experience. Phlebotomy certification required within 6 months of hire.
- Minimum one year experience as a clinical research coordinator.
- Excellent communication skills; must be able to communicate with patients and family participating in clinical trials.
- Experience as research coordinator.
- Experience with patient data and/or databases.
- Proficient time management skills and ability to successfully manage multiple studies.
- Phlebotomy certification and experience with blood draws.
In order to be considered, you must upload your cover letter, resume, and a list of 3-5 professional references with contact information.
The University of Florida is committed to non-discrimination with respect to race, creed, color, religion, age, disability, sex, sexual orientation, gender identity and expression, marital status, national origin, political opinions or affiliations, genetic information and veteran status in all aspects of employment including recruitment, hiring, promotions, transfers, discipline, terminations, wage and salary administration, benefits, and training.
This is a time-limited position.
Application must be submitted by 11:55 p.m. (ET) of the posting end date.
Health Assessment Required: Yes
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