Clinical Research Coordinator I - Gastrointestinal Surgery

Classification Title:

Clinical Research Coord I

Job Description:

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.

Duties include:

1. 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.
2. 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.
   
   
3. 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.
   
   
4. 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.
   
   
5. 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.

Advertised Salary:

$39,000-$43,000

Minimum Requirements:

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.

Special Instructions to Applicants:

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.

This requisition has been reposted. Previous applicants are still under consideration and need not apply

Application must be submitted by 11:55 p.m. (ET) of the posting end date.

Health Assessment Required: Yes