Florida Atlantic University - Boca Raton, FL

posted about 2 months ago

Full-time - Entry Level
Boca Raton, FL
Educational Services

About the position

Florida Atlantic University is seeking a Research Coordinator & Biorepository and Lab Administrator. This position reports to the Director of the Clinical Research Unit within the Division of Research and plays a crucial role in initiating and managing clinical research studies. The Research Coordinator will work collaboratively with researchers across various FAU colleges, hospital partners, and the community to ensure the accurate execution of research protocols in compliance with HRPP, Good Clinical Practices, HIPAA, and other obligations to patients, Principal Investigators, research teams, and sponsors. The role involves direct interaction with patients and subjects, including recruiting and screening potential participants for eligibility in studies managed by the Clinical Research Unit (CRU). This includes gathering information from medical records, physician referrals, and advertisements, as well as scheduling visits for screening and evaluation. The Research Coordinator will assist with the informed consent process, ensuring that participants fully understand their responsibilities throughout the study. Additionally, the coordinator will create and maintain participant charts and coordinate appointments for studies requiring these services. The position also entails performing research procedures according to established protocols, participating in research training, and conducting phlebotomies and the collection of biological specimens if certified. The coordinator will assist and guide other research coordinators and maintain regulatory documentation for clinical trials, ensuring compliance with IRB-approved protocols. The role requires consistent follow-up with patients and subjects, maintaining a courteous and professional demeanor with faculty and staff within FAU and collaborating institutions. In addition to research coordination, the position includes biorepository and laboratory duties. The Research Coordinator will oversee training for staff on lab equipment, develop and maintain procedures for the FAU biorepository, and ensure that lab supplies are current and equipment is properly calibrated. Responsibilities also include scheduling biohazard pickups, ordering research study supplies, and maintaining records related to dry ice management. This multifaceted role is essential for the successful operation of clinical research and biorepository activities at FAU.

Responsibilities

  • Establish liaisons between the CRU and researchers across FAU colleges, HBOI, hospital partners, and the community.
  • Coordinate and ensure the accurate execution of research protocols in accordance with HRPP, Good Clinical Practices, HIPAA, and required obligations to patients, Principal Investigators, research teams, and sponsors.
  • Interface directly with patients/subjects, caregivers, and principal investigators in support of clinical research and clinical trials.
  • Recruit and screen potential patients/subjects for eligibility to the studies managed in the CRU.
  • Assist with the informed consent process and ensure that the patient/subject fully understands what is required of them throughout the study.
  • Create and maintain participant charts and coordinate participant appointments for studies conducted in the CRU.
  • Perform research procedures according to protocols and participate in research training offered to researchers.
  • Perform phlebotomies (if certified) and collect other biological specimens; conduct off-site visits to collect patient data and specimens if required.
  • Collect, organize, and maintain source documentation and regulatory documentation for clinical trials.
  • Ensure protocols are being followed as approved by the IRB.
  • Participate in research activities by assisting with the collection of data.
  • Interact with patients/subjects and families in a courteous and professional manner.
  • Establish initial site selection visits and follow up on monitor visits and closeout visits for studies.
  • Assist with preparation of NIH and IRB applications.
  • Work with CRU administrators in feasibility assessments and billing processes when required.
  • Serve as backup coordinator for various studies and perform other work-related duties as assigned.
  • Provide oversight of training for all staff using lab equipment to ensure proper use and appropriate lab procedures.
  • Develop and maintain procedures and policies for the FAU biorepository.
  • Maintain the lab to ensure no expired supplies are stored and all equipment is calibrated and running properly.
  • Resolve lab issues and maintain temperature logs for all specimens.
  • Schedule biohazard pickup and disposal for the entire center.
  • Order research study supplies and assist with inventory of lab/center supplies.

Requirements

  • Master's degree from an accredited institution in an appropriate area of specialization; or a bachelor's degree from an accredited institution in an appropriate area of specialization and two years of appropriate experience required.
  • Current Research Coordinator certification by the Association of Clinical Research Professionals or Society of Clinical Research Associates for a minimum of 6 months; or willingness to obtain CCRC certification after 6 months of employment.
  • A valid Florida driver's license is required.

Nice-to-haves

  • Experience with Workday.

Benefits

  • 403(b)
  • Dental insurance
  • Employee assistance program
  • Health insurance
  • Life insurance
  • Loan forgiveness
  • On-the-job training
  • Flexible Spending plans
  • Paid time off including vacation and sick leave, 1 personal day, 9 paid holidays, and paid winter break (at President's discretion).
  • Paid Community Engagement Volunteer Service Day
  • Employee Educational Scholarship Program (EESP) for eligible Staff/Faculty - Tuition assistance after 6 months of full-time employment.
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