Research Coordinator II – Regulatory (DDI)

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Job Title

Research Coordinator II – Regulatory (DDI)

Location

Weston

Facility

Krupa Center Weston

Department

Research Administration-Research Innov and Educ

Job Code

000540

Shift

Days

Schedule

8:30pm-5:00pm

Job Summary

Job Details

Join the Cleveland Clinic Florida team at the Krupa Center in Weston, where you will work alongside highly skilled and compassionate caregivers and board-certified family practice physicians to provide patient-first healthcare. Cleveland Clinic is consistently recognized as one of the top hospitals in the nation, offering quality preventive care, management of chronic conditions and comprehensive services for the entire family. At Cleveland Clinic, you will receive strong support and recognition, collaborate with dedicated professionals and build a rewarding career with one of the world’s most respected healthcare organizations.

As a Research Coordinator II, your role is crucial in documenting data, maintaining timely reports, preparing audits, and ensuring compliance within the department. In this role, you will provide dedicated regulatory support across the DDI research portfolio, ensuring compliance, accuracy, and consistency in all regulatory processes. Core responsibilities include 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, and supporting investigators, trainees, and coordinators with regulatory documentation and training. While the numerous responsibilities can be difficult to manage at times, your team will encourage you to enhance your skills and find your place within the Cleveland Clinic system.

A caregiver in this role works days from 8:30 a.m. -- 5:00 p.m.

A caregiver who excels in this role will:

• 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.

• constituents.

• 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.

Minimum qualifications for the ideal future caregiver include:

• 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

Preferred qualifications for the ideal future caregiver include:

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

• IRB experience

Physical Requirements:

• Ability to perform work in a stationary position for extended periods

• Ability to operate a computer and other office equipment

• Ability to communicate and exchange accurate information

• In some locations, ability to move up to 25 pounds

Personal Protective Equipment:

• Follows standard precautions using personal protective equipment as required.

The policy of Cleveland Clinic Health System and its system hospitals (Cleveland Clinic Health System) is to provide equal opportunity to all of our caregivers and applicants for employment in our drug free environment. All offers of employment are followed by testing for controlled substances.

Cleveland Clinic Health System administers an influenza prevention program. You will be required to comply with this program, which will include obtaining an influenza vaccination on an annual basis or obtaining an approved exemption.

Decisions concerning employment, transfers and promotions are made upon the basis of the best qualified candidate without regard to color, race, religion, national origin, age, sex, sexual orientation, marital status, ancestry, status as a disabled or Vietnam era veteran or any other characteristic protected by law. Information provided on this application may be shared with any Cleveland Clinic Health System facility.

If applying for a Florida position, please see the following website for more information on the background screening requirements required by the Agency of Health Care Administration: https://info.flclearinghouse.com/

Please review the Equal Employment Opportunity poster.

Cleveland Clinic is pleased to be an equal employment opportunity employer.