Job Summary:

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.