Clinical Research Coordinator

Clinical Research Coordinator

Coordinate clinical research studies for the principal investigators and coordinates and promotes 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 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.

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 to promote the research program within the community. Work directly with principal investigator to design appropriate recruitment strategies, communication plan, and patient safety monitoring plan.

Conducts research studies according to 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.

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 documents in the 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 department.

Ensure compliance with protocol guidelines and requirements of regulatory agencies, including required documentation and record retention. Monitor patient's progress and reports adverse events/protocol deviations as required. Participating in quality assurance activities of the sponsor, the FDA, IRB, 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, the Institutional Review Board (IRB).

Obtains, patient biologic 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 department 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.

Education, Credentials, Licenses: Associate degree in related field with 2 years related experience or Bachelor's degree in related field

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: Dependent upon educational background.

FLSA Status: Exempt

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