Clinical Research Coordinator Apply locations: Edgewood, Kentucky Time type: Full time Posted on: Posted Yesterday Job requisition id: JR303309 Engage with us for your next career opportunity. Right Here. Job Type: Regular Scheduled Hours: 40 Job Summary: Coordinate clinical research studies for the principal investigators and promote research programs within St. Elizabeth and the community. Responsible for collaborating with physicians to open studies, educating staff and clients about current studies, and obtaining informed consents. Responsibilities include screening and enrolling subjects in studies and managing their participation according to ethical, regulatory, and protocol-specific requirements. Responsibilities also include data collection and submission as well as regulatory compliance. Demonstrate respect, dignity, kindness, and empathy in each encounter with all patients, families, visitors, and other employees regardless of cultural background. Job Description: Coordinate clinical research studies conducted by the principal investigator. Has a thorough understanding of the protocols. Educate and provide in-service to associates in the Medical Center that will be affected by the study. Collaborate with physicians to open new studies at St. Elizabeth and promote the research program within the community. Work directly with the principal investigator to design appropriate recruitment strategies, communication plans, and patient safety monitoring plans. Conduct research studies according to Office for Human Research Protections (OHRP) and US Food and Drug Administration (FDA) regulations and guidelines. Follow Good Clinical Practices, Good Laboratory Practices, St. Elizabeth Healthcare policies, and maintain related certifications. Confer with potential study participants to explain the study and obtain the study-specific, IRB-approved informed consent, as well as appropriate HIPAA Authorization before performing any study-related procedures. Review with the participant and family all study requirements including diagnostic procedures, questionnaires, and treatments. Conduct participant research visits and collect/record research-related data. Submit data to study sponsors as required and document in the patient’s medical record as appropriate. Maintain the integrity and privacy of the participant’s research protocol chart with all required source data. Initiate/coordinate drug orders, laboratory/imaging procedures, and treatments for participants based on protocol requirements. Maintain investigational device/product inventory or coordinate investigational device/product accountability with St. Elizabeth pharmacy or appropriate clinical department. Ensure compliance with protocol guidelines and requirements of regulatory agencies, including required documentation and record retention. Monitor patient’s progress and report adverse events/protocol deviations as required. Participate in quality assurance activities of the sponsor, the FDA, IRB, and other regulatory and accrediting agencies. Assist with documentation and submission for approvals, revisions, renewals, informed consents, unanticipated problems, and study closure as mandated by the study sponsors, St. Elizabeth Healthcare, and the Institutional Review Board (IRB). Obtain patient biologic specimens or work with SEH laboratory/SEH clinical nursing staff to obtain laboratory specimens (blood, urine, saliva, etc.). Maintain IATA certification for the safe handling and shipping of biologic specimens. Work with clinical departments and finance department to ensure appropriate billing/coding of study-related activity. Assist with the development of research billing grids, budgets, and monitoring of reimbursements. Perform other duties as assigned. Education, Credentials, Licenses: Bachelor’s Degree in related area of study. Specialized Knowledge: Understanding of research processes. Ability to effectively manage and prioritize multiple tasks while meeting tight deadlines. Proficiency with Excel, Word, Outlook, and PowerPoint is imperative. Ability to work effectively and in a professional manner with physicians, leadership, SEH/SEP associates, patients, external business partners, representatives of regulatory agencies, and the general public. Kind and Length of Experience: 2 years’ experience in Clinical Research. FLSA Status: Exempt Right Career. Right Here. If you're looking for the right careers in healthcare, the right place to be is at St. Elizabeth. Join us, and you'll take pride in the level of care we offer our community. About Us St. Elizabeth Healthcare is one of the oldest, largest, and most respected medical providers in the Northern Kentucky, Southeastern Indiana, and Greater Cincinnati region. Together with St. Elizabeth Physicians, the affiliated multi-specialty physician and advanced practice provider organization, we are transforming healthcare through innovative treatments, cutting-edge technology, and a heart for our community. We’re right here, sharing one mission: to improve the health of the people we serve. J-18808-Ljbffr