Research Coordinator I - Medicine - Gastroenterology and Hepatology

Job Duties

• Recruits and interviews potential study participants for both therapeutic and non-therapeutic research studies.
• Collections patient information, processes study documents, and enters data into research databases.
• Collections, 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.
• Cohorts 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.
• Aids in data collection and the reporting of Serious Adverse Events (SAEs) to appropriate regulatory agencies and sponsors.
• Cohorts IRB submissions and communications with local and central IRBs.
• Orders study supplies and equipment as needed by the research team.
• Schedules regularly scheduled research team meetings and provides study updates and progress reports.
• Might 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

• A high school diploma or GED.
• Three years of relevant experience.

Preferred Qualifications

• A 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.