Summary

The Department of Medicine, Section of Gastroenterology and Hepatology, is looking for an experienced Research Coordinator to coordinate day to day activities of gastroenterology/hepatology related research activities. The candidate will work with a team and alongside Dr. Maya Balakrishnan. Duties and responsibilities include working directly with research patients on screening, enrolling, and monitoring for clinical trial compliance. The candidate will manage and enter data into study databases. Duties will also include regulatory reporting and compliance, as well as writing IRB protocols, including amendments and renewals. Duties will also include involvement in observational trials. The position is full-time, 5 days a week.

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.
• Other duties as assigned.

Minimum Qualifications

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

Preferred Qualifications

• Bachelor's degree in a related field. No experience required with preferred degree.
• Ability to speak Spanish.
• Clinical trial drug experience.
• Must be experienced with Excel spreadsheets and research databases.
• Must have the ability to understand and implement patient studies and protocols.
• Organized, self-motivated, teamwork, works well under pressure, multitasking.