Research Coordinator - Rotroff

19 May 2024

Vacancy expired!

Job 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 timelines.
  • 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.
  • 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 constituents.
  • Documents the education and training of research personnel as needed.
  • Conducts and documents 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.
  • 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 clinical research 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.
  • 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.

Competencies (Complexity of Work):

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

Work Experience:

  • Minimum three years clinical research experience required. Bachelor's degree in healthcare or science field may offset two years of clinical research experience requirement.

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.

Coordinates the compliant implementation and conduct of human subject research projects typically of medium workload and medium complexity.

  • ID: #41173231
  • State: Ohio Cleveland 44195 Cleveland USA
  • City: Cleveland
  • Salary: TBD
  • Job type: Full Time
  • Showed: 2022-05-19
  • Deadline: 2022-07-17
  • Category: Et cetera