Clinical Research Coord II

University of Florida•Jacksonville, FL

19h•Hybrid

About The Position

The Clinical Research Coordinator II is responsible for the coordination of assigned research studies and educational programs funded by federal, industry and private foundation grants, in which the department is involved. Funded topics can include pain, opioid alternatives, EMS, sepsis, geospatial, biomarker, and precision medicine. This position will report to the Assistant Director of Clinical Research, in collaboration with Principal investigators, in the Department of Emergency Medicine. Serves as lead coordinator on multiple emergency medicine based studies. Reviews and follows research protocols to screen and enroll patients into IRB approved studies, including specimen collections, laboratory processing and device education. Performs study follow-up visits including phlebotomy, vital signs, psychometric surveys, and dispensing of investigational products. Interacts with research participants to support study eligibility determination and consenting of participants according to approved protocols. Creates study checklists and case report forms. Enters data into appropriate study databases and develops databases as needed. Provides accurate and timely data collection, documentation, entry, and reporting in both sponsor and UF databases. Leads site initiation, auditing monitoring, and close-out visits for studies. Ensures IRB and regulatory documents are properly filed in regulatory study binders and that regulatory binders are up to date for review by auditors and study monitors. Ensures that research participants are properly associated in EPIC. Collaborates with hospital/ED/pain clinic/pharmacy staff, management, and other departments to train and communicate ED-led research studies for a team approach to completing research activities. Trains clinical research coordinators, research coordinators, OPS research assistants, and student interns on protocols for participant enrollment. Implements good clinical practice (GCP) and follows the Code of Federal Regulations (CFR) and Health Insurance Portability and Accountability Act (HIPAA), and follows the University of Florida policies and procedures and research related protocols. Performs biomedical procedures such as biospecimen collection, centrifuging, pipetting, freezing and sample storage and trains staff on specific study processing. Ensures proper IATA shipping procedures are followed. Acts as a liaison between subject, investigators, IRB, sponsors and other relevant healthcare professionals who are part of the research or patient care team for smooth and informed implementation of studies. Develops study and educational outreach materials, spreadsheets, and other materials for departmental projects and grants. Responsible for the monitoring and tracking of project deliverables and completing reports. Assists the Associate Chair of EM Research, Assistant Chair of EM Research, Assistant Director of Clinical Research, Associate Director of Clinical Research, and PI’s in identifying new funding opportunities and proposal development related to pediatric, EMS, pain, patient safety, sepsis and precision medicine topics. Participates in EM research and quality improvement related state partnerships. Completes other assigned duties as determined by EM Research leadership team.

Requirements

Bachelor’s degree in an appropriate area and two years of relevant experience; or an equivalent combination of education and experience.
Valid driver's license.

Nice To Haves

Experience in phlebotomy, specimen processing, data collection, and clinical research.
Knowledge of laboratory procedures, specimen handling, and storage.
Computer and software proficiency in Microsoft Word, Excel, PowerPoint, Adobe, CANVA and other programs.
Excellent interpersonal skills and the ability to prioritize and effectively communicate verbally and in writing.
Ability to coordinate multiple tasks and work independently and productively in a fast paced, deadline-oriented environment.
Integrity, careful attention to detail; ability to maintain confidentiality, demonstrate professionalism and respect for subjects’ rights and individual needs.
Willing to learn and maintain skills in accordance with HIPAA regulations and Good Clinical Practice guidelines.

Responsibilities

Coordinate assigned research studies and educational programs.
Screen and enroll patients into IRB approved studies.
Perform specimen collections, laboratory processing, and device education.
Conduct study follow-up visits including phlebotomy, vital signs, psychometric surveys, and dispensing of investigational products.
Determine study eligibility and obtain consent from participants.
Create study checklists and case report forms.
Enter data into study databases and develop databases as needed.
Ensure accurate and timely data collection, documentation, entry, and reporting.
Lead site initiation, auditing, monitoring, and close-out visits.
Maintain IRB and regulatory documents in study binders.
Ensure research participants are properly associated in EPIC.
Collaborate with hospital staff, management, and other departments to train and communicate research studies.
Train clinical research coordinators, research assistants, and student interns on protocols.
Implement good clinical practice (GCP), CFR, HIPAA, and University of Florida policies.
Perform biomedical procedures such as biospecimen collection, centrifuging, pipetting, freezing, and sample storage.
Train staff on specific study processing procedures.
Ensure proper IATA shipping procedures are followed.
Act as a liaison between subject, investigators, IRB, sponsors, and healthcare professionals.
Develop study and educational outreach materials, spreadsheets, and other materials.
Monitor and track project deliverables and complete reports.
Assist in identifying new funding opportunities and proposal development.
Participate in EM research and quality improvement related state partnerships.
Complete other assigned duties as determined by EM Research leadership team.