This position is no longer open for applications

The department of Medicine, division of Hepatology has an exciting opportunity for a full-time Clinical Research Coordinator to work on the UHealth campus. The Clinical Research Coordinator 2 provides professional level support for research clinical studies involving human subjects and assists in the design of studies, generation of databases, and update and maintenance of documentation. Moreover, the Clinical Research Coordinator develops, verifies, and implements procedures to accomplish research goals.

Department Specific Functions

Candidate will work within the Division of Digestive Health and Liver Diseases, but will be responsible for working with Investigators in other divisions on collaborative sponsored research studies. A large portion of the coordinator’s job will involve being the lead coordinator for an NIH-sponsored clinical trial of transplanting kidneys from deceased donors with hepatitis C into hepatitis C-negative patients (THINKER-NEXT). This will include all aspects of coordinating a clinical research trial in terms of regulatory reporting, assisting with medication dispensing from the investigational pharmacy, and helping to process and ship specimens. Candidate will be expected to meet with study monitors and maintain all regulatory documents. Hours may fluctuate depending on clinic and procedure days; therefore, candidate must be flexible in hours. In addition, the candidate will be involved in other clinical research studies across campus, and assisting with ongoing research in the Goldberg lab.

• Serve as primary research coordinator for an NIH-sponsored transplant clinical trial at Jackson Memorial Hospital.
• Maintains study files according to protocol requirements, UM and department policy.
• Recruit and screen participants, obtain informed consent, and follow participants according to study calendar.
• Ensure study medication is kept secure and under the appropriate temperature condition and maintain accurate study drug accountability.
• Ability to work independently and/or in a collaborative environment.
• Monitors, documents, reports, and follows-up on study unanticipated/adverse events and protocol deviations.
• Prepares IRB submissions including continuing reporting, reportable events, amendments and follow ups to IRB.
• Helping to process patient specimens (e.g., blood) to be stored and shipped to the central research laboratory.
• Collect data from patient charts, medical records, interviews, questionnaires, diagnostic tests and other sources.
• Responsible for ordering and maintaining stock of necessary supplies and participant incentives (petty cash fund and/or gift card accounts).
• Assists with study orientation and protocol related in-services to research team and clinical staff.
• Support multiple liver disease research studies by performing a variety of duties.
• Review medical records of patients at the University of Miami and the Veteran Health Administration (VHA) for other clinical research studies.
• Enter abstracted data from the medical record into RedCap or other electronic data capture system.
• Participate in outreach events.
• Bilingual (English and Spanish) preferred.
• Perform other duties as assigned by the PI.

This list of duties and responsibilities is not intended to be all-inclusive and may be expanded to include other duties or responsibilities as necessary.

Prefer Phlebotomy certification or obtainable with in 2 months of hiring.

CORE QUALIFICATIONS

• Bachelor’s Degree in relevant field required, or combination education and experience.
• Minimum 2 years of relevant experience, or experience working with patients in a clinical setting and/or research setting
• Prefer Phlebotomy certification or obtainable with in 2 months of hiring

Knowledge, Skills and Attitudes:

• Skill in completing assignments accurately and with attention to detail.
• Ability to analyze, organize and prioritize work under pressure while meeting deadlines.
• Ability to process and handle confidential information with discretion.
• Ability to work evenings, nights, and weekends as necessary.
• Commitment to the University’s core values.
• Ability to work independently and/or in a collaborative environment.