Assistant Director, Clinical Research - -Emergency Medicine Research

University of Florida•Jacksonville, FL

2d•Onsite

About The Position

The Assistant Director of Clinical Research will manage departmental research coordinators and laboratory staff working 7 days per week, oversee clinical research studies and industry clinical trials from design, implementation to close-out, establish systems and accountability for maintaining clearly defined regulations and protocols, and develop standard operating procedures and processes. Areas of research focus include pharmacologic and nonpharmacologic pain management, sepsis, biomarkers, pharmacogenomics, EMS, pediatrics, trauma, toxicology, and device trials.

Requirements

Master's degree in appropriate area of specialization and two years of appropriate experience; or a bachelor's degree in appropriate areas of specialization and four years of experience.
Driver’s license

Nice To Haves

Certified Clinical Research Professional or equivalent.
Four of more years of conducting clinical research and supervision of research staff.
Biomedical laboratory experience.
Experience in emergency, trauma or critical care settings.
Experience in developing clinical trial budgets, studies involving investigational drugs or devices, protocols and implementation.
Experience in managing federal, private and federal research, personnel, data analysis, and verbal presentation skills.

Responsibilities

Responsible for direct oversight and supervision of all clinical research coordinators, research coordinators, research assistants, biological scientists, and undergraduate/graduate students.
Oversees the onboarding and training of new staff and completes evaluations in adherence to the University of Florida Human Resources guidelines.
Establishes performance goals and measures to promote ongoing professional development of all coordinators.
Oversees all scheduling and works with the Department to ensure accurate staff effort reporting for financial management.
Collaborates with internal and external principal investigators (PIs) and divisional/department leadership to implement clinical research studies and programs in the Department of Emergency Medicine.
Oversees all site initiation, monitoring, and closeout visits, audits and inspection visits.
Provides regular updates of clinical research studies progression to PIs, leadership, and study sponsors; proactively identifies and resolves issues during study implementation and dissemination; and manages escalation of study-related issues.
Serves as a liaison between subject (as needed), 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.
Reviews and follows IRB approved clinical research protocols to screen and enroll patients.
Co-leads in developing study protocols and checklists; oversees accurate coordinator completion of source document data and case report forms.
Confirms the accuracy of research clinical studies databases and assists in developing databases.
Ensures that regulatory documents are properly handled by coordinators and that regulatory binders are up to date for review by auditors and study monitors.
Manage the biological lab and biological processes for clinical research studies.
Implements good clinical practice (GCP) and follows the Code of Federal Regulations (CFR) and Health Insurance Portability and Accountability Act (HIPAA), and follows all University of Florida policies and procedures.
Assist the Department Chair, Associate Chair of Emergency Medicine Research, Assistant Chair of Emergency Medicine Research, and Associate Director in identifying new funding opportunities and proposal development.
Responsible for oversight of hospital billing for research subjects and department invoice/PO submissions.
Collaborate with Associate Chair, Assistant Chair, and Principal Investigators for research grants, i.e. negotiation of budget, data use agreements, confidentiality disclosure agreements in accordance with UF policy.
Leads and coordinates meetings, identifies and collaborates with external collaborators, investigators, funders, and multidisciplinary professional project team members in multiple departments.
Assists with manuscript and abstract development and submission, participates in literature reviews, poster development, and database maintenance of publications.
Maintains appropriate research related certifications (i.e., CCRP, and others) and mentors coordinators in obtaining certifications.
Completes other assigned duties as determined by the Associate Chair and Assistant Chair.