- 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.
- Language required
- Language preferred
- 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.
- 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.