Job Overview

As one of the oldest medical schools in the country, the UC College of Medicine has a reputation for training best-in-class health care professionals and developing cutting-edge procedures and research that improves the health and clinical care of patients.

The UC Department of Emergency Medicine at the University of Cincinnati has been an independent academic unit within the College of Medicine since 1984. It is responsible for the medical direction of the University of Cincinnati Medical Center, Center for Emergency Care (CEC) and the Emergency Medicine Residency Training Program.

The Department of Emergency Medicine is seeking a Clinical Research Professional who will serve as the research division's regulatory coordinator in charge of regulatory submissions to the IRB and FDA, sponsor interface, document management and research compliance. This team member will work with the clinical research professionals team that coordinates research studies in an acute care setting.

Essential Functions

• Participant Management: Recruit or assist in the recruitment of study participants based on study criteria, Consent participants into research studies, schedule and conduct participant study visits, coordinate tests and procedures with medical staff.   
• Manage investigational products including ordering, storage and return or destruction of study drugs, devices or lab supplies. 
• Accurately record clinical and study data from participant visits, entering into CRF or electronic data capture in a timely manner and ensure completeness of study records. 
• Work closely with principal investigator and other healthcare providers to ensure smooth study operations. 
• Stay current with relevant medical knowledge, clinical guidelines and therapeutic advancements related to the study’s area of focus. 
• Educate research and clinical staff on protocol details, ensuring consistent understanding and application across the study team. 
• Collaborate with investigators, clinical staff and institutional teams to design and implement study specific order sets with the EMR.  
• Act as a liaison with medical staff, university departments, ancillary departments and/or satellite facilities.
• Serve as a peer-mentor within the department, supporting management and in various responsibilities as appropriate including the development of less experienced team members.
• Contribute to the development of new processes, procedures, tools and training to enhance clinical research activities, compliance, and efficiency.
• Ensure research is conducted according to the study protocol, compliance with contract principles, federal regulations, laws and University of Cincinnati/University of Cincinnati Physicians Company (UCPC) policy and operating procedures.
• Prepare, submit, and assist with multiple levels of research documentation (i.e. IRB submissions, educational materials, reports, grant renewal reports, and study forms).
• Prepare and maintain FDA applications for investigational New Drugs (INDs). Maintain regulatory documentation.
• Assist in modifying protocols, reports and procedure manuals. 
• Writing of consents and creation of study documents.  
• Conduct adverse event reporting to both study authorities, institutional authorities and regulatory authorities. Manage office documents including training certificates, CVs, and licenses.
• Act as liaison between participants, investigators, study personnel, study sponsors and regulatory bodies.
• Prepare for site monitoring visits, audits and inspections by sponsors or regulatory bodies. 
• Perform related duties based on departmental need. This job description can be changed at any time.

Required Education

• Bachelor’s Degree in Biology, Health Sciences, or a related field.
• Five (5) years of relevant work experience and/or other specialized training can be used in lieu of education requirement.

Additional Qualifications Considered

• Master's degree.
• Experience working in an academic research setting.
• Experience with Redcap or eRegulatory.
• Clinical Research Professional Certification.

Physical Requirements/Work Environment