St. Elizabeth Healthcare
Location
Edgewood, Kentucky
Coordinate clinical research studies by managing subject enrollment, data collection, and regulatory compliance. Collaborate with physicians to open new studies and ensure adherence to protocol and FDA guidelines.
Requires an Associate degree with 2 years of related experience or a Bachelor's degree in a related field. Must have an understanding of research processes and the ability to maintain IATA certification.
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, patient safety monitoring plan, ensure compliance with protocol guidelines and requirements of regulatory agencies, including required documentation and record retention. Assist in coordinating study documents for review by the IRB and Sponsor. 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. Identify or assist in the screening of potentially eligible participants. Consent participants and coordinate, plan and execute study visits and provide instructions and reimbursement to participants. Conduct participant research visits and collect/record research related data. Submit data to study sponsors as required and document in the participant’s study chart as appropriate. Maintain the integrity and privacy of participant’s research protocol chart with all required source data. Demonstrate accuracy and organizational skills and the ability to follow through on requests and meet timelines. Communicate with study team and supporting clinical groups in professional and clear manner to support study activities. 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). 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. Support the data-management process for clinical research projects, including addressing data queries from data managers, project statistician, and sponsors. Performs other duties as assigned. Education, Credentials, Licenses: Associate degree in related field with 2 years related experience OR Bachelors degree in related field Specialized Knowledge: Understanding of research processes Kind and Length of Experience: Dependent upon educational background. See Education, Credentials, and Licenses. 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. 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.