Summary

The Department of Medicine, Section of Gastroenterology and Hepatology, is seeking an experienced Research Coordinator to oversee the day-to-day activities of clinical trials. Responsibilities include working directly with research participants to screen, enroll, and monitor patients for clinical trial compliance. The selected candidate will manage and enter data into study databases and ensure the accuracy and integrity of research records.

Additional duties include regulatory reporting and compliance, as well as preparing and submitting IRB protocols, amendments, and renewals. The Research Coordinator will also support observational studies and perform other research-related duties as assigned by the Principal Investigator (PI).

This is a full-time position requiring on-site attendance five days per week.

Job Duties

• Recruits and interviews potential study participants for both therapeutic and non-therapeutic research studies.
• Collects patient information, processes study documents, and enters data into research databases.
• Collects, processes, ships, and maintains documentation for blood and other biological specimens according to study protocol requirements.
• Plans and schedules research visits for study participants in accordance with protocol requirements.
• Maintains appropriate study documentation and tracks investigational product (IP) compliance at both the protocol and participant levels. Independently maintains study-level documentation, including regulatory binders, enrollment logs, and participant registration within the system of record.
• Serves as a liaison among the Principal Investigator (PI), sponsors, Research Manager, and OCR Research Finance to support all aspects of study operations.
• Schedules research participants for protocol-required tests and procedures, including laboratory testing, imaging studies, and other research-related assessments. Retrieves and submits results to the appropriate parties.
• Coordinates site monitoring visits with sponsors, contract research organizations (CROs), the study team, the investigational pharmacy, and the Principal Investigator.
• Facilitates study start-up activities, including drafting and preparing study-related documents required to initiate research studies at the site.
• Assists with data collection and the reporting of Serious Adverse Events (SAEs) to appropriate regulatory agencies and sponsors.
• Coordinates IRB submissions and communications with local and central IRBs.
• Orders study supplies and equipment as needed by the research team.
• Participates in regularly scheduled research team meetings and provides study updates and progress reports.
• May collaborate on the preparation of scientific abstracts and manuscripts, as appropriate.
• Gains experience working as a scribe in the Gastroenterology Clinic one day per week, based on the PI's schedule.
• Performs 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 preferred; no experience required with preferred degree.
• Experience coordinating industry-sponsored clinical trials is required.
• Proficiency in Microsoft Excel and clinical research databases, including REDCap, OnCore, and electronic data capture (EDC) systems, is required.
• Demonstrated ability to understand, implement, and adhere to clinical research protocols and study procedures.
• Spanish language proficiency is preferred but not required.
• Strong organizational and time-management skills with the ability to work independently and collaboratively as part of a team.
• Self-motivated, detail-oriented, and capable of managing multiple priorities in a fast-paced environment.
• Ability to work effectively under pressure while maintaining accuracy and professionalism.