Research Coordinator II - Regulatory (DDI)

Benefits

Qualifications

• •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
• •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
• •Follows standard precautions using personal protective equipment as required
• •6 more items(s)

Responsibilities

• •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.,timelycompletion and communication of regulatory documents, the development of data capture andmonitoringplans, 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 toassistin protocol interpretation,enrollmentand safety questions
• •Collaborate with primaryinvestigators,sponsorsand research staff to plan,conductand evaluate project protocols, including research subject recruitment
• •Monitor andreportproject status
• •Complete regulatory documents, datacaptureand monitoring plans
• •Develop andmaintainknowledge of researchprotocolsto coordinate the comprehensive and compliant execution of assigned protocols
• •Assistwith preparation for audits and response to audits
• •Assistwith the development of training and educational material for assigned research protocols
• •Provide and document education as needed
• •Conduct and document the informed consent process
• •Assistwith research project budget development as needed
• •14 more items(s)