Research Coordinator I/II

$47,528 - $47,528/Yr

Cleveland Clinic - Cleveland, OH

Full-time - Entry Level

Cleveland, OH

Ambulatory Health Care Services

About the position

The position involves coordinating the compliant implementation and conduct of human subject research projects that are typically of medium workload and medium complexity. The individual in this role will ensure adherence to research protocol requirements, which may include the maintenance of regulatory documents and binders, data management, and the submission of Institutional Review Board (IRB) applications. Effective communication with the research team regarding these submissions is essential. Additionally, the coordinator may be responsible for reporting and completing Serious Adverse Events and safety logs as defined by the protocol, as well as completing necessary forms for the Food and Drug Administration (FDA) and sponsors in accordance with Good Clinical Practice (GCP) guidelines. The role requires regular communication with sponsors, monitors, and research personnel to ensure compliance with all aspects of the study. The coordinator may act as a liaison between investigators, research personnel, outside study personnel, and central research administration offices to assist in protocol interpretation, enrollment, and safety inquiries. Collaboration with the study team is crucial for scheduling pre-site selection visits, site initiation visits, webinars, monitoring, and close-out visits. The coordinator will work closely with the primary investigator, sponsor, and research staff to plan, conduct, and evaluate project protocols, including the recruitment of research subjects. Monitoring and reporting on project status is a key responsibility, along with completing regulatory documents, data capture, and monitoring plans. The coordinator will also be involved in protocol-related activities and may need to attain and maintain clinical competencies for unlicensed caregivers, such as phlebotomy and vital signs monitoring, as required. Maintaining the quality of research data is essential, as is a solid understanding of basic study design concepts and assigned research protocols. The coordinator will assist in preparing for audits and responding to audit findings, as well as developing and maintaining research tools like spreadsheets and questionnaires. Maintaining certification records for study personnel and documenting their education and training is also part of the role. The coordinator may participate in the informed consent process and assist the principal investigator with research study design and protocol development, as well as contribute to the development of research project budgets. Other duties may be assigned as necessary.

Responsibilities

• Coordinates the implementation and conduct of research projects ensuring adherence to research protocol requirements.
• Maintains regulatory documents and binders, data management, and IRB submissions.
• Reports and completes Serious Adverse Events and safety logs as defined per protocol.
• Communicates with sponsors, monitors, and research personnel to ensure study compliance.
• Serves as a liaison between investigators, research personnel, and central research administration offices.
• Collaborates with the study team to schedule pre-site selection visits, site initiation visits, webinars, monitoring, and close-out visits.
• Works with the primary investigator, sponsor, and research staff to plan, conduct, and evaluate project protocols.
• Monitors and reports project status.
• Completes regulatory documents, data capture, and monitoring plans.
• Completes protocol-related activities.
• Attains and maintains clinical competencies for unlicensed caregivers as required.
• Monitors research data to maintain quality.
• Understands basic concepts of study design and demonstrates comprehension of assigned research protocols.
• Develops and maintains knowledge of research protocol to coordinate 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 and questionnaires.
• Maintains study personnel certification records.
• Documents the education and training of research personnel as needed.
• Participates in the conduct and documentation of the informed consent process.
• Assists PI with research study design and development of the research protocol.
• Contributes to research project budget development.
• Performs other duties as assigned.

Requirements

• High School Diploma or GED required.
• Minimum three years' experience as a Research Coordinator I or performing the role of a Research Coordinator I.
• Associate's or Bachelor's degree in health care or science related field preferred; may substitute for two years of experience requirement.
• Demonstrated proficiency with a variety of computer-based skills, especially in word processing, spreadsheets, database, and presentation software.
• Solid written and verbal communication skills.
• Self-directed with the ability to work collaboratively with a multidisciplinary team.

Nice-to-haves

• Associate's or Bachelor's degree in health care or science related field may substitute for two years of experience requirement.

Benefits

• Healthcare coverage
• Dental insurance
• Vision insurance
• Retirement plan options
• Paid time off
• Professional development opportunities