This position does include a weekend on-call component. You will be on-call 1-2 times per month, and it is scheduled in advance.

Work schedule start and end times may fluctuate at times based on workload and patient admissions.

Some travel to Fairview Hospital or Hillcrest Hospital may be required at times.

Responsibilities:

• 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.
• 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. 
• Communicates with sponsors, monitors, research personnel to ensure all aspects of study compliance.  
• May serve 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 study team to schedule pre-site selection visits, site initiation visits, webinars, monitoring and close-out visits. 
• 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 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 assist PI with research study design and development of the research protocol.
• May contribute to 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 preferred. 
• Bachelor’s degree in healthcare or science field 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. Education preference.

Languages:

• Language required
• Language preferred

Certifications:

• None required.

Complexity of Work:

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

Work Experience:

• Minimum three years’ experience as a Research Coordinator I or performing the role of a Research Coordinator I. Associate's or Bachelor's degree in health care or science related field may offset two years of 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.
• May require working irregular hours.

Personal Protective Equipment:

• Follows standard precautions using personal protective equipment as required.