Clinical Research Coordinator Jobs

About The Position

Requirements

• Associate degree in a related field with two years of related experience, or a bachelor’s degree in a related field.
• Understanding of research processes.
• Ability to manage and prioritize multiple tasks while meeting tight deadlines.
• Proficiency with Excel, Word, Outlook, and PowerPoint.
• Ability to work professionally and effectively with physicians, leadership, St. Elizabeth Healthcare and St. Elizabeth Physicians associates, patients, external business partners, regulatory agency representatives, and the general public.
• Maintain related certifications, including IATA certification for safe handling and shipping of biologic specimens.

Responsibilities

• Coordinate clinical research studies conducted by principal investigators and maintain a thorough understanding of study protocols.
• Educate and provide in-service training to Medical Center associates affected by studies.
• Collaborate with physicians to open new studies and promote the research program within St. Elizabeth Healthcare and the community.
• Work with the principal investigator to develop recruitment strategies, communication plans, and patient safety monitoring plans.
• Conduct research studies in accordance with OHRP and FDA regulations and guidelines, Good Clinical Practices, Good Laboratory Practices, and St. Elizabeth Healthcare policies.
• Explain studies to potential participants and obtain IRB-approved informed consent and applicable HIPAA authorization before study-related procedures.
• Review study requirements, including diagnostic procedures, questionnaires, and treatments, with participants and their families.
• Conduct participant research visits and collect and record research-related data.
• Submit data to study sponsors and document information in patients’ medical records as appropriate.
• Maintain the integrity and privacy of research protocol charts and required source data.
• Initiate or coordinate protocol-required drug orders, laboratory and imaging procedures, and treatments.
• Maintain investigational device or product inventory or coordinate accountability with the pharmacy or appropriate clinical department.
• Ensure compliance with protocols and regulatory requirements, including documentation and record retention.
• Monitor participant progress and report adverse events and protocol deviations as required.
• Participate in quality assurance activities conducted by sponsors, the FDA, the IRB, and other regulatory or accrediting agencies.
• Assist with documentation and 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.
• Maintain IATA certification for safe handling and shipping of biologic specimens.
• Work with clinical and finance departments to ensure appropriate billing and coding of study-related activity.
• Assist with research billing grids, budgets, and reimbursement monitoring.
• Perform other duties as assigned.

Benefits

• Competitive pay and comprehensive health coverage within the first 30 days.
• Paid time off.
• Flexible work schedules.
• Retirement savings with employer match.
• Tuition reimbursement.
• Professional development opportunities.
• Wellness programs.
• Mental health programs.
• Recognition programs.
• Mentorship and internal mobility opportunities for career advancement.