Responsibilities:

• Coordinates the implementation and conduct of research projects ensuring adherence to research protocol requirements including: timely completion and communication of regulatory documents, the development of data capture and monitoring plans, reporting of Serious Adverse Events as they occur and completion of Food and Drug Administration (FDA) and sponsor forms in accordance with GCP timelines.
• 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.
• 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.
• Maintains professional relationships, including frequent and open effective communication with internal and external
• constituents.
• Assists with the development of training and educational material for assigned research protocols.
• Provides and documents education as needed.
• Conducts and documents the informed consent process.
• Potentially assists with research project budget development.
• Other duties as assigned.

Education:

• Bachelor's degree in health care or science related field preferred.
• Bachelor's degree in healthcare or science field may offset two years of clinical research experience requirement.
• 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.
• Demonstrated basic computer proficiency.
• Strong organizational, communication and interpersonal skills.
• Must be self-directed with demonstrated ability to work independently yet establish cooperative relationships with colleagues.

Certifications:

• None required.

Complexity of Work:

• Requires critical thinking skills, decisive judgment and the ability to work with minimal supervision.
• Must be able to work in a stressful environment and take appropriate action.

Work Experience:

• Minimum three years clinical research experience required.
• Bachelor's degree in healthcare or science field may offset two years of clinical research experience requirement.

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.