Research Coordinator I - Enterprise Biorepository
Coordinates the compliant implementation and conduct of human subject research projects typically of low workload and low complexity.
The ideal candidate demonstrates excellence in customer service, communication and attention to detail in the implementation and conduct of human subject research projects. The primary focus of the position is the Cleveland Clinic BioRepository and will require on-site duties at Cleveland Clinic’s Main Campus as well as other sites within the Health System.
For more information about the BioRepository, please visit: www.clevelandclinic.org/biorepository.
- 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.
- 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.
Complexity of Work:
- Requires excellent organizational, written, and verbal communication skills.
- Must be able to take direction and appropriate action in a stressful environment.
- 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.
- A high degree of dexterity to produce materials on a computer.
- Requires normal or corrected vision and hearing to normal range.
- Extensive sitting and frequent walking, occasional lifting or carrying up to 25 pounds.
- May have some exposure to communicable diseases or body fluids.
- May require working irregular hours.
Personal Protective Equipment:
- Follows standard precautions using personal protective equipment as required.