Manager Clinical Research Informatics Jobs in Kentucky

Clinical Research Coordinator

Coordinate clinical research studies for the principal investigators and coordinate and promote the research program within St. Elizabeth and the community. Responsible for collaborating with physicians to open studies, educating staff about current studies, educating clients about 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 regulatory compliance. Demonstrate respect, dignity, kindness, and empathy in each encounter with all patients, families, visitors, and other employees regardless of cultural background.

Job Duties:

• Coordinate clinical research studies conducted by the principal investigator.
• Perform study conduct in accordance with the protocol, manual of operations, and standard operating procedures (SOPs).
• Collaborate with physicians to open new studies at St. Elizabeth and to promote the research program within the community.
• Work directly with principal investigator to assist in the design of recruitment strategies, communication plan, and patient safety monitoring plan.
• 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 study data to study sponsors as required and enter in patient's medical record as appropriate.
• Maintain the integrity and privacy of 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 departments.
• Administer investigational study medication and document in the medical record or coordinate the administration of investigational medication by clinical personnel.
• 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).
• 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, the IRB, and other regulatory and accrediting agencies.
• Performs duties within the scope of the appropriate state Nurse Practice Act and conducts research studies according to the Office for Human Research Protections (OHRP) and US Food and Drug Administration (FDA) regulations and guidelines. Follows Good Clinical Practices, Good Laboratory Practices, St Elizabeth Healthcare policies, and maintains related certifications.
• Obtains patient biological specimens or works with SEH laboratory / SEH clinical nursing staff to obtain laboratory specimens (blood, urine, saliva, etc.). Maintains IATA certification for the safe handling and shipping of biologic specimens.
• Works with clinical departments and finance departments to ensure appropriate billing/coding of study related activity. Assists with development of research billing grids, budgets, and monitoring of reimbursements.
• Performs other duties as assigned.

Minimum Requirements:

• Education, Credentials, Licenses: Bachelor's degree in nursing. If eligible, must have a Compact (multi-state) License in their primary state of residence.
• Specialized Knowledge: Ability to effectively manage and prioritize multiple tasks while meeting tight deadlines.
• Kind and Length of Experience: 2 Years of Nursing Experience

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.