Clinical Research Coord I - Dept. of Surgery
University of Florida
Gainesville, FL
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JOB DETAILS
SALARY
$43,000–$52,000 Per Year
LOCATION
Gainesville, FL
POSTED
30+ days ago
Apply now (https://secure.dc4.pageuppeople.com/apply/674/gateway/default.aspx?c=apply&lJobID=536481&lJobSourceTypeID=796&sLanguage=en-us) Job no: 536481
Work type: Staff Full-Time
Location: Main Campus (Gainesville, FL)
Categories: Grant or Research Administration
Department: 29770100 - MD-Transplant Center - Admin
Classification Title:
Clinical Research Coordinator I
Classification 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.
Job Description:
Coordination of Protocol Subjects & Data Collection:
+ Performs subject screening and consent for clinical protocols under direction of Principal Investigator.
+ Serves as patient resource and educator for information regarding the study or clinical symptoms.
+ Prepares and ships central laboratory samples as per protocol requirements.
+ Collects baseline and follow-up data from the medical record.
+ Documents findings in appropriate source records and case report forms.
+ Schedules and attends clinic appointments for patients as required by protocol.
+ Communicates with nursing staff and OR Staff about patient care according to protocols.
+ Assists with operating room protocol requirements where appropriate.
+ Records patient symptoms and adverse events in conjunction with care providers.
+ Reports and follows 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
+ Maintains knowledge base of Good Clinical Practice Guidelines and Federal Code of Regulation 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.
Research Support
+ Assists medical and scientific partners to design protocol methodologies for basic science, preclinical studies, and clinical protocols.
+ 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 Investigational Review Board and Animal Care Committees as needed.
+ Designs Case Report Forms and Source Documents for clinical protocols where required.
+ Assists with grant development projects as needed for preclinical studies within Division.
+ Assists with manuscript preparation and abstract submission for principal investigators.
+ Submits protocols to the RAC 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 institutional Investigational Review Board under direction of Principal Investigator for clinical research protocols.
Tracks the type of study services performed to ensure that they are compensated appropriately
+ Performs billing review for study subjects
+ Dispense human subjects' payment 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
Expected Salary:
$43,000 - $52,000
Required Qualifications:
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.
Preferred:
Excellent communication skills; must be able to communicate with patients and family participating in clinical trials.
Experience as research coordinator preferred.
Experience with patient data and/or databases.
Proficient time management skills and ability to successfully manage multiple studies.
Special Instructions to Applicants:
In order to be considered, you must upload your cover letter and resume.
Application must be submitted by 11:55 p.m. (ET) of the posting end date.
This requisition has been reposted. Previous applicants are still under consideration and need not apply.
Health Assessment Required:Yes
Advertised: 15 Jul 2025 Eastern Daylight Time
Applications close: 30 Jul 2025 Eastern Daylight Time
About the Company
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