Under moderate supervision of the Principal Investigator, Senior Research Assistant or Manager, the Study Coordinator I is responsible for a variety of activities in support of clinical research studies. These responsibilities include recruiting and evaluating patients for studies; collecting and organizing patient data; scheduling patients for study visits; maintaining and updating data generated by the study and IRB applications
PRINCIPAL DUTIES AND RESPONSIBILITIES:
- To provide assistance on clinical research studies as per studies guidelines and protocols.
- Is responsible for the Institutional Review Board submissions and other regulatory forms as well as adhering to the timelines of the study start-up process.
- To assist with the development of the informed consent documents, source documents and other documents as applicable.
- To recruit and evaluate potential study patients. Per protocol instruction, conducts telephone interviews or schedules patients for study visits and screenings.
- To interact with patients/subjects with regards to study, including patient education, procedural instruction, and follow-up. May serve as a liaison between patient and physician.
- Is responsible for collecting data and maintaining patient information database for study. Maybe required to input data, do minimum analysis and run various reports. Maintains patient’s records as part of record keeping function.
- To understand and proficiently communicate all components of research documents, such as protocol, informed consent, investigator brochure and research instructions.
- Is responsible for mailing various study information or packets to study participants.
- To answer any phone calls and inquiries regarding study protocol. Refers participants to principal investigator or co-investigators.
- To monitor and set up any needed equipment.
- To interact with study monitors, scheduling monitoring visits as indicated and providing timely responses to study queries.
- To communicate with study participant’s clinical care providers as needed and document research visits within the electronic health record, EPIC, in compliance with institutional policies.
- To maintain inventory and orders supplies when necessary.
- To contribute to a research team environment, serving as back-up coordinator to support other studies in department, cross-training/peer-mentoring other team members and contributing to research meetings.
- All other duties as assigned.
BA or BS degree required. New graduate with relevant course or project work.
- Excellent interpersonal skills are required for working with the study participants.
- Good oral and written communication skills.
- Knowledge of clinical research protocols.
- Knowledge of computer programs, databases, etc. including excel, word, and PowerPoint.
- Excellent organizational skills and ability to prioritize a variety of tasks.
- Careful attention to detail.
- Ability to demonstrate professionalism and respect for subjects’ rights and individual needs.
- Simple statistical programming.