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.Education:
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.Certifications:
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.Work Experience:
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.
Experience in consenting patients, regulatory/IRB, and working with critical care studies strongly preferred.Physical Requirements:
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.