Research Coordinator III - Pulmonary Hypertension
Company: Cleveland Clinic
Location: Cleveland
Posted on: June 26, 2022
Job Description:
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.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.Demonstrates exceptional coordination and
compliance of the implementation and conduct of human subject
research projects typically with a high workload and high
complexity. Assists with research study design and protocol
development as applicable.
Keywords: Cleveland Clinic, Cleveland , Research Coordinator III - Pulmonary Hypertension, Healthcare , Cleveland, Ohio
Didn't find what you're looking for? Search again!
Loading more jobs...