Research Coordinator I

Cleveland Clinic - Cleveland, OH

Full-time - Entry Level

Cleveland, OH

10,001+ employees

Ambulatory Health Care Services

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. Cleveland Clinic is recognized as one of the top hospitals in the country. As a Research Coordinator I, you will demonstrate exceptional coordination and compliance of the implementation and conduct of human subject research projects, typically of low workload and low complexity. You will also assist with research study design and protocol development. The ideal future caregiver is someone who has clinical research experience in pediatrics, including IRB submissions and maintenance, consenting, patient visits, and monitoring visits. This role requires flexibility, self-motivation, and a keen attention to detail, thriving both independently and as part of a team. By taking this opportunity, you will join an inclusive, supportive team that strongly believes in supporting one another in both personal and career goals and promoting from within the team. At Cleveland Clinic, we know what matters most. That's why we treat our caregivers as if they are our own family, and we are always creating ways to be there for you. Here, you'll find that we offer resources to learn and grow, a fulfilling career for everyone, and comprehensive benefits that invest in your health, your physical and mental well-being, and your future. When you join Cleveland Clinic, you'll be part of a supportive caregiver family that will be united in shared values and purpose to fulfill our promise of being the best place to receive care and the best place to work in healthcare.

Responsibilities

• Assists with the coordination, implementation, and conduct of research projects ensuring adherence to research protocol requirements.
• Maintains regulatory documents and binders, data management, IRB submissions, and communication of such to the research team.
• Responsible for reporting/completion of Serious Adverse Events and/or safety log as defined per protocol as they occur.
• Completes Food and Drug Administration (FDA) and sponsor forms in accordance with GCP guidelines as applicable.
• Communicates with sponsors, monitors, and 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 and 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.
• Performs other duties as assigned.

Requirements

• High School Diploma or GED required; Associate or bachelor's degree in health care or science related field preferred.
• 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.
• 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.

Nice-to-haves

• Experience with pediatric clinical research.
• Knowledge of IRB submissions and maintenance.
• Experience with patient visits and monitoring visits.

Benefits

• Comprehensive health benefits including medical, dental, and vision insurance.
• 401k retirement savings plan with employer matching.
• Paid time off and holidays.
• Tuition reimbursement for further education.
• Employee wellness programs and mental health support.