Updated 3 days ago

Research Coordinator III

Cleveland, OH 44102
Full-time, Part-time
$26.28 - $34.45
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Responsibilities:
  • Independently directs large, complex, multi-center clinical research protocols/programs and 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, and the development of data capture and monitoring plans.
  • May be responsible for reporting 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, and research personnel to ensure all aspects of study compliance.-
  • 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.
  • Completes and may oversee 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.
  • Oversees and monitors research data to maintain quality.
  • Understands basic concepts of study design.
  • 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 develop or 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.
  • Assists with the development of training and educational material for assigned research protocols, and documents education as needed.
  • Conducts and documents the informed consent process.
  • Assists PI with research study design and development of research protocol.
  • May submit the study to appropriate agencies in support of the research programs and assist with annual and other reporting requirements.
  • Will contribute to or assist with 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 strongly preferred.
    • Bachelor's degree 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.Certifications:
      • None Required.Complexity of Work:
        • Is self-directed in planning, prioritizing and performing job requirements with minimal supervision.-
        • Exhibits the desire to expand job knowledge and skills through training and skill development.
        • Must be able to work in a stressful environment and take appropriate action.Work Experience:
          • Minimum five years' experience as a Research Coordinator II or performing the role of a Research Coordinator II.- Bachelor's degree in health care or science related field may offset two years of experience requirement.
          • Experience in consenting patients, regulatory/IRB, and working with critical care studies 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.
Posting ID: 631145772Posted: 2021-06-16Job Title: Research Coordinator Iii