Clinical Research Coordinator I - Plastic Surgery
Job no: 515851
Work type: Staff Full-Time
Location: Main Campus (Gainesville, FL)
Categories: Health Profession, Research/Scientific/Grants
Department:29141600 - MD-SURGERY-PLASTIC
Clinical Research Coord IJob Description:
The Department of Surgery is seeking applicants for a Clinical Research Coordinator I to coordinate ongoing clinical research trials within the Division of Plastic 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.
Coordination of Protocol Compliance, such as: maintaining a knowledge base of Good Clinical Practice Guidelines and Federal Code of Regulations regarding clinical trial conduct; coordinating and maintaining HIPAA compliance for assigned studies; communicating with interdisciplinary health team in care of patients involved in research studies to ensure regulatory compliance; interacting with local laboratories and diagnostic study centers to ensure clinical protocol requirements are complete for studies; coordinating efforts of Investigational Pharmacist and maintaining site records for Good Clinical Practice and sponsor guidelines.
Research Support, such as: assisting medical and scientific partners to design protocol methodologies for basic science, preclinical studies, and clinical protocols; helping with protocol development and protocol endpoints to ensure statistical and clinical relevance of studies; assessing clinical needs by performing literature review and discussion with faculty advisors within Division; preparing and submitting filings of protocols to Investigational Review Board and Animal Care Committees as needed; designing Case Report Forms and Source Documents for clinical protocols where required; assisting with grant development projects; maintaining awareness of Good Laboratory Practices as needed for preclinical studies within Division; assisting with manuscript preparation and abstract submission for principal investigators; submitting protocols to the RAC and IRB offices to assure compliance under the direction of the senior study coordinator; organizing and maintaining regulatory files for clinical studies performed within Division; interacting with institutional Investigational Review Board under direction of Principal Investigator for clinical research protocols.
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.
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.Preferred Qualifications:
- 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:
Advertised: 19 Feb 2021 Eastern Standard Time
Applications close: 26 Feb 2021 Eastern Standard Time