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Research Coordinator II - Respiratory

req # 138064 Location Cleveland, Ohio Additional Locations Garfield Heights, Ohio; Mayfield Heights, Ohio Facilities Cleveland Clinic Main Campus|Fairview Hospital|Marymount Hospital|Hillcrest Hospital Professional Area Research and Data Department 3366 Respiratory Institute Admin-Respiratory Institute Jobcode T99498 Schedule Full Time Shift 8:00am-5:00pm

Job Details

Coordinates the compliant implementation and conduct of human subject research projects typically of medium workload and medium complexity. **Must be able to travel to other regional hospitals (Fairview, Marymount, Hillcrest). **Must be able to work weekend coverage occasionally.

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.

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.
  • Must be comfortable working with high-risk patient population.
  • Must be comfortable working with handling samples and laboratory procedures.
  • Will have MICU consenting and responsible for processing of some human samples.
  • Must be comfortable in a lab setting.

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.
  • Experience working and communicating with stakeholders/physicians on studies preferred.
  • Consenting and regulatory experience 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.
  • May require working irregular hours.
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