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Responsibilities:

• 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.

Education:

• High School Diploma or GED.  Associate or bachelor's degree in health care or science related field preferred.  Degree may offset experience requirement.

Languages:

• Language required.
• Language preferred

Certifications:

• 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.
• 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.

Work Experience:

• Minimum two years clinical research or healthcare experience required.
• Associate 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.

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.

The policy of Cleveland Clinic Health System and its system hospitals (Cleveland Clinic Health System) is to provide equal opportunity to all of our caregivers and applicants for employment in our drug free environment. All offers of employment are followed by testing for controlled substances.

Cleveland Clinic Health System administers an influenza prevention program. You will be required to comply with this program, which will include obtaining an influenza vaccination on an annual basis or obtaining an approved exemption.

Decisions concerning employment, transfers and promotions are made upon the basis of the best qualified candidate without regard to color, race, religion, national origin, age, sex, sexual orientation, marital status, ancestry, status as a disabled or Vietnam era veteran or any other characteristic protected by law. Information provided on this application may be shared with any Cleveland Clinic Health System facility. 

If applying for a Florida position, please see the following website for more information on the background screening requirements required by the Agency of Health Care Administration: https://info.flclearinghouse.com/

Please review the Equal Employment Opportunity poster. 

Cleveland Clinic is pleased to be an equal employment opportunity employer.