Research Coordinator III
Job posting number: #7085246 (Ref:138967)
Posted: September 14, 2021
Application Deadline: Open Until Filled
- Independently directs large, complex, multi-center clinical research protocols/programs and coordinates the 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, and the development of data capture and monitoring plans.
- May be responsible for reporting 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.
- Communicates with sponsors, monitors, and research personnel to ensure all aspects of study compliance.
- Serves as a liaison between investigators, research personnel, outside study personnel and central research administration offices to assist in protocol interpretation, enrollment and safety questions.
- 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.
- Completes and may oversee 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.
- Oversees and monitors research data to maintain quality.
- Understands basic concepts of study design.
- 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 develop or 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.
- Assists with the development of training and educational material for assigned research protocols, and documents education as needed.
- Conducts and documents the informed consent process.
- Assists PI with research study design and development of research protocol.
- May submit the study to appropriate agencies in support of the research programs and assist with annual and other reporting requirements.
- Will contribute to or assist with 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 strongly preferred.
- Bachelor’s degree may offset two years of 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.
- Continually demonstrates competency with defined requirements for the position as established by Cleveland Clinic.
- None Required.
Complexity of Work:
- Is self-directed in planning, prioritizing and performing job requirements with minimal supervision.
- Exhibits the desire to expand job knowledge and skills through training and skill development.
- Must be able to work in a stressful environment and take appropriate action.
- Minimum five years’ experience as a Research Coordinator II or performing the role of a Research Coordinator II. Bachelor's degree in health care or science related field may offset two years of experience requirement.
- 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.
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