What are the responsibilities and job description for the Research Coordinator I position at OneTen?
Job Summary:
Join the Cleveland Clinic team, where you will work alongside passionate caregivers and provide patient-first healthcare. At Cleveland Clinic, you will work alongside passionate and dedicated caregivers, receive endless support and appreciation, and build a rewarding career with one of the most respected healthcare organizations in the world.
As a Research Coordinator, you will coordinate the compliant implementation and conduct of human subject research projects, typically of medium workload and medium complexity. You will get to join a multi-disciplinary, talented team and work on studies that impact future patient diagnoses and treatments. This role offers individuals the ability to contribute to our mission of innovation by being a part of and helping to develop research studies. Our studies are new and first of their kind for several reasons and we continue to innovate within research within our field.
The future caregiver is someone who:
• Has previous human subjects research experience (preferred).
• Has written and verbal communication skills.
• Has organizational and multitasking skills.
• Can work independently.
This is a rewarding opportunity that offers growth-oriented projects, mentorship, support, and resources. There are many opportunities for growth and development in research. Cleveland Clinic has a robust research education program, and we encourage caregivers to learn new skills that will benefit their work and their careers.
At Cleveland Clinic, we know what matters most. That is 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 will 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 will 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 roles.
Responsibilities:
- 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.
- Performs other duties as assigned.
Education:
- High School Diploma or GED. Associate's or Bachelor's degree in health care or science related field preferred. Degree may offset experience requirement.
- 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.
Languages:
- Language required
- Language preferred
Certifications:
- None required.
Complexity of Work:
- Requires excellent organizational, written, and verbal communication skills.
- Must be able to take direction and appropriate action in a stressful environment.
Work Experience:
- Minimum two years clinical research or healthcare experience required.
- Associate's or Bachelor's degree in healthcare or science field may offset experience requirement.
- 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.
Physical Requirements:
- 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
Personal Protective Equipment:
- Follows standard precautions using personal protective equipment as required.
