Research Coordinator II – Regulatory (DDI)

Cleveland Clinic•Weston, FL

1d•Onsite

About The Position

As a Research Coordinator II at Cleveland Clinic Florida's Krupa Center in Weston, you will play a crucial role in documenting data, maintaining timely reports, preparing audits, and ensuring compliance within the department. This position provides dedicated regulatory support across the DDI research portfolio, ensuring accuracy and consistency in all regulatory processes. Key responsibilities include preparing and submitting IRB applications, maintaining regulatory binders, serving as the primary liaison with the IRB and Compliance office, ensuring protocol adherence, and supporting investigators, trainees, and coordinators with regulatory documentation and training. You will work within a highly skilled and compassionate team dedicated to patient-first healthcare, contributing to one of the nation's top hospitals.

Requirements

High School Diploma or GED and three years of experience as a Research Coordinator I or performing the role of a Research Coordinator I OR Associate's or Bachelor's degree in health care or science related and one year of experience as a Research Coordinator I or performing the role of a Research Coordinator I
Proficient with computer-based skills such as word processing, spreadsheets, database and presentation software
Understand basic concepts of study design

Nice To Haves

Associate or Bachelor's degree in health care or science related field
IRB experience

Responsibilities

Documenting data, maintaining timely reports, preparing audits, and ensuring compliance within the department.
Provide dedicated regulatory support across the DDI research portfolio, ensuring compliance, accuracy, and consistency in all regulatory processes.
Preparation and submission of IRB applications such as new studies, amendments, renewals, and closures.
Maintenance of regulatory binders for all active and pipeline studies.
Serving as the primary liaison with the IRB and Compliance office.
Ensuring protocol adherence across all DDI studies.
Supporting investigators, trainees, and coordinators with regulatory documentation and training.
Coordinate the implementation and conduct of research projects, ensuring adherence to research protocol requirements (e.g., timely completion and communication of regulatory documents, the development of data capture and monitoring plans, reporting of Serious Adverse Events, completion of Food and Drug Administration (FDA) and sponsor forms, etc.).
Serve as a liaison between investigators, research personnel, outside study personnel and central research administration offices to assist in protocol interpretation, enrollment and safety questions.
Collaborate with primary investigators, sponsors and research staff to plan, conduct and evaluate project protocols, including research subject recruitment.
Monitor and report project status.
Complete regulatory documents, data capture and monitoring plans.
Develop and maintain knowledge of research protocols to coordinate the comprehensive and compliant execution of assigned protocols.
Assist with preparation for audits and response to audits.
Assist with the development of training and educational material for assigned research protocols.
Provide and document education as needed.
Conduct and document the informed consent process.
Assist with research project budget development as needed.