Research Coordinator I

Cleveland Clinic

1d•Onsite

About The Position

Coordinates the compliant implementation and conduct of human subject research projects typically of low workload and low complexity. Assists with the coordination, implementation, and conduct of research projects ensuring adherence to research protocol requirements which may include: maintenance of regulatory documents and binders, data management, IRB submissions and communication of such to the research team. May be responsible for reporting/completion of Serious Adverse Events and/or safety log as defined per protocol as they occur and completion of Food and Drug Administration (FDA) and sponsor forms in accordance with GCP guidelines as applicable. Communicates with sponsors, monitors, research personnel to ensure all aspects of study compliance. Collaborates with study team to schedule pre-site selection visits, site initiation visits, webinars, monitoring and close-out visits. May collaborate with primary investigator, sponsor and research staff to plan, conduct and evaluate project protocols, including research subject recruitment. Monitors and reports project status. Completes regulatory documents, data capture and monitoring plans. Assists with completion of protocol related activities. As delegated, may be required to attain and maintain clinical competencies for unlicensed caregivers such as phlebotomy, vital signs, ECG, POC testing and other testing as required. Monitors research data to maintain quality. Understands basic concepts of study design. Demonstrates comprehension of assigned research protocols. Develops and maintains knowledge of research protocol to coordinate the comprehensive and compliant execution of assigned protocols. Assists with preparation for audits and response to audits. May assist in the development and maintenance of research tools, such as spreadsheets, questionnaires and/or brochures. Maintains study personnel certification records (License, CV, CITI). Maintains professional relationships, including frequent and open effective communication with internal and external customers. Documents the education and training of research personnel as needed. May participate in the conduct and documentation of the informed consent process. May contribute to research project budget development.

Requirements

Minimum two years clinical research or healthcare experience required
Demonstrated proficiency with a variety of computer-based skills, especially in the use of word processing, spreadsheets, database and presentation software, and the ability to undertake internet searches
Solid written and verbal communication skills
Must be self-directed with demonstrated ability to work in collaboration and cooperation with members of a multidisciplinary team
Within 90 days of hire, must successfully complete certification in Human Subjects Research as required by the Responsible Conduct of Research guidelines adopted by Cleveland Clinic
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
Ability to move up to 25 pounds
Follows standard precautions using personal protective equipment as required
Compliance with influenza prevention program, including annual influenza vaccination or approved exemption

Nice To Haves

Associate or bachelor's degree in health care or science related field preferred
Associate or bachelor's degree in healthcare or science field may offset experience requirement

Responsibilities

Assists with the coordination, implementation, and conduct of research projects ensuring adherence to research protocol requirements
Maintenance of regulatory documents and binders
Data management
IRB submissions and communication of such to the research team
Reporting/completion of Serious Adverse Events and/or safety log as defined per protocol
Completion of Food and Drug Administration (FDA) and sponsor forms in accordance with GCP guidelines
Communicates with sponsors, monitors, research personnel to ensure all aspects of study compliance
Collaborates with study team to schedule pre-site selection visits, site initiation visits, webinars, monitoring and close-out visits
Collaborates with primary investigator, sponsor and research staff to plan, conduct and evaluate project protocols, including research subject recruitment
Monitors and reports project status
Completes regulatory documents, data capture and monitoring plans
Assists with completion of protocol related activities
Attains and maintains clinical competencies for unlicensed caregivers such as phlebotomy, vital signs, ECG, POC testing and other testing as required
Monitors research data to maintain quality
Understands basic concepts of study design
Demonstrates comprehension of assigned research protocols
Develops and maintains knowledge of research protocol to coordinate the comprehensive and compliant execution of assigned protocols
Assists with preparation for audits and response to audits
Assists in the development and maintenance of research tools, such as spreadsheets, questionnaires and/or brochures
Maintains study personnel certification records (License, CV, CITI)
Maintains professional relationships, including frequent and open effective communication with internal and external customers
Documents the education and training of research personnel as needed
Participates in the conduct and documentation of the informed consent process
Contributes to research project budget development
Performs other duties as assigned