Clinical Research Coordinator

St. Elizabeth Healthcare•Edgewood, KY

14d

About The Position

The Clinical Research Coordinator coordinates clinical research studies conducted by principal investigators and promotes the research program within St. Elizabeth Healthcare and the community. The role collaborates with physicians to open studies, educates affected staff and potential participants, explains study requirements, and obtains study-specific informed consent and HIPAA authorization. The coordinator screens and enrolls participants, manages their participation in accordance with ethical, regulatory, and protocol requirements, conducts research visits, collects and submits data, and maintains regulatory compliance and study records. The position works with principal investigators on recruitment strategies, communication plans, and patient safety monitoring plans. It coordinates protocol-related drug orders, tests, procedures, treatments, and investigational product accountability; monitors participant progress and reports adverse events and protocol deviations; and assists with regulatory submissions and study closeout. The coordinator may obtain biologic specimens or coordinate their collection with clinical staff, maintains IATA certification for specimen handling and shipping, and works with clinical and finance departments on research billing, budgets, and reimbursements. Other duties may be assigned.

Requirements

Associate degree in a related field and 2 years of related experience, or a bachelor's degree in a related field.
Understanding of research processes.
Ability to effectively manage and prioritize multiple tasks while meeting tight deadlines.
Proficiency with Excel, Word, Outlook, and PowerPoint.
Ability to work effectively and professionally with physicians, leadership, associates, patients, external business partners, regulatory agency representatives, and the general public.

Responsibilities

Coordinate clinical research studies conducted by principal investigators and maintain a thorough understanding of study protocols.
Educate and provide in-service training to affected Medical Center associates; collaborate with physicians to open studies and promote the research program.
Work with the principal investigator to develop recruitment strategies, communication plans, and patient safety monitoring plans.
Conduct studies in accordance with OHRP and FDA regulations and guidelines, Good Clinical Practices, Good Laboratory Practices, and St. Elizabeth Healthcare policies; maintain related certifications.
Explain studies to potential participants, obtain IRB-approved informed consent and HIPAA authorization before study procedures, and review study requirements with participants and families.
Conduct participant research visits and collect, record, and submit research data; document information in medical records as appropriate and maintain source data and participant research charts securely and with integrity.
Coordinate protocol-required drug orders, laboratory and imaging procedures, and treatments; maintain investigational product inventory or coordinate product accountability with the appropriate department.
Ensure compliance with protocols and regulatory requirements, including documentation and record retention; monitor participant progress and report adverse events and protocol deviations.
Participate in quality assurance activities conducted by sponsors, the FDA, the IRB, and other regulatory or accrediting agencies.
Assist with submissions for study approvals, revisions, renewals, informed consents, unanticipated problems, and study closure.
Obtain biologic specimens or coordinate specimen collection with laboratory or clinical nursing staff, and maintain IATA certification for safe specimen handling and shipping.
Work with clinical and finance departments to support appropriate billing and coding; assist with research billing grids, budgets, and reimbursement monitoring.
Perform other duties as assigned.