Summary

The Department of Medicine, Section of Gastroenterology and Hepatology, is seeking an experienced Research Coordinator to support and manage daily research activities within the Hepatology program. This role works closely with a multidisciplinary research team and collaborates directly with Dr. Prasun K. Jalal.

The Research Coordinator will be responsible for screening, enrolling, and monitoring research participants to ensure adherence to clinical trial protocols. Additional responsibilities include data management, maintaining accurate and timely entries in study databases, and performing regulatory tasks, such as preparing and submitting IRB protocols, amendments, and renewals. The position will also contribute to the conduct of observational studies and support overall regulatory compliance for the research program.

Job Duties

• Recruits and interviews potential study participants in non-therapeutic and therapeutic studies. 
• Collects patient information; processes documents and enters information into a database. 
• Collect, process, ship, and maintain paperwork for blood and/or biological specimens according to procedures outlined in study protocol.
• May perform EKGs/ECGs, and obtain vital signs for study participants. (Employees may be required to receive on the job training of  EKGs/ECGs prior to performing on study participants.)
• Plan and schedule upcoming research visits for study subjects, according to protocol requirements. 
• Maintains appropriate documentation. Tracks IP compliance at the protocol-and subject level. Independently maintain appropriate study-level documentation including regulatory binders, enrollment logs, patient registration in the system of record, etc.
• Liaises with PI, Sponsor, Research Manager and OCR Research Finance to support all aspects of study activity.
• Schedules research participant for tests and procedures such as laboratory tests, imaging, and other studies specific for the research protocol. Retrieves and submits test results to appropriate party.
• Coordinate Site Monitoring visits with  sponsor,CRO, study team, investigational pharmacy, and Principal Investigator.
• Facilitate the study start up process, including: Draft multiple study documents to initiate the study start up process at the site.
• Assist with data collection and reporting of Serious Adverse Events to appropriate regulatory agencies and sponsors.
• Coordinate IRB applications to local/central IRB. 
• Order supplies and equipment.
• Help in manuscript preparation and publication.
• Performs other job duties as assigned.

Minimum Qualifications

• High School diploma or GED.
• Three years of relevant experience.

Preferred Qualifications

• Bachelor’s degree in a related field or equivalent relevant experience. No experience required with preferred degree.
• Strong preference for candidates pursuing medical school or those who hold a medical degree.
• Experience with clinical trial drug studies.
• Proficiency in Excel and experience using research databases.
• Ability to understand and follow patient study protocols.
• Spanish language skills are a plus but not required.