Research Coordinator III - Ophthalmology Retina/Uveitis

Cleveland Clinic

12d•Onsite

About The Position

Join Cleveland Clinic’s Main Campus where research and surgery are advanced, technology is leading-edge, patient care is world class and caregivers are family. Here, you will work alongside a passionate and dedicated team, receive endless support and appreciation, and build a rewarding career with one of the most respected healthcare organizations in the world. The Research Coordinator III is embedded within the clinical research department and supports clinical trials across multiple ophthalmology subspecialties including glaucoma, cornea, ocular oncology, neuro-ophthalmology and plastics. This role collaborates closely with physicians, sponsors and monitors to support the successful conduct of research studies. Responsibilities include screening, enrolling and consenting patients for clinical trials, preparing and maintaining IRB submissions and sponsor-required regulatory binders, ensuring readiness for monitoring visits and audits and collecting and entering study data in accordance with protocol requirements while maintaining HIPAA and research compliance. The coordinator also schedules patient visits, manages investigational drug and device trials and supports special projects including multi-center studies and investigation into new drug and device protocols. A caregiver in this position works between 7:30am to 4:00pm.

Requirements

High School Diploma or GED and five years of experience as a Research Coordinator II or performing the role of a Research Coordinator II OR Bachelor’s Degree in a healthcare or science-related field and three years of experience
Demonstrated proficiency with a variety of computer-based skills (word processing, spreadsheets, databases and presentation software)
Understanding of the basic concepts of study design

Nice To Haves

Associate’s or Bachelor’s Degree in a healthcare or science-related field

Responsibilities

Demonstrate exceptional coordination and compliance of the implementation and conduct of human subject research projects.
Assist with research study design and protocol development as applicable.
Independently direct large, complex, multi-center clinical research protocols/programs and coordinate the implementation and conduct of research projects, ensuring adherence to research protocol.
Report Serious Adverse Events and/or safety as they occur and complete Food and Drug Administration (FDA) and sponsor forms in accordance with GCP guidelines.
Communicate with sponsors, monitors and research personnel to ensure all aspects of study compliance.
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 caregivers to plan, conduct and evaluate project protocols, including research subject recruitment.
Monitor and report project status.
Complete regulatory documents, data capture and monitoring plans.
Complete and oversee protocol related activities.
As delegated, attain and maintain clinical competencies for unlicensed caregivers, such as phlebotomy, vital signs, ECG, POC testing and other testing as required.
Oversee and monitor research data to maintain quality.
Develop and maintain knowledge of research protocols to coordinate the comprehensive and compliant execution of assigned protocols.
Assist with the preparation for audits and response to audits.
Develop or assist in the development and maintenance of research tools, such as spreadsheets, questionnaires and/or brochures.
Maintain study personnel certification records (License, CV, CITI).
Conduct and document the informed consent process.
Assist the PI with research study design and development of research protocol.
Submit the study to appropriate agencies in support of the research programs and assist with annual and other reporting requirements.
Contribute to or assist with research project budget development.