Research Coordinator II - Digestive Disease Institute

ccf; Oklahoma; On-site; USD 65,000 - 90,000; Full time

Job summary

Cleveland Clinic Main Campus in Cleveland is seeking a Research Coordinator II for the Digestive Disease Institute. You will enroll patients into clinical trials, conduct study visits, and collect questionnaires, focusing on inflammatory bowel disease (IBD).

Join a world-class team dedicated to advancing care, research, and education while supporting participants through complex protocols. The role involves coordinating regulatory documents, data management, IRB submissions, and communication

Responsibilities

• Coordinate compliant implementation and conduct of human subject research projects.
• Maintain regulatory documents and binders, conduct data management, complete IRB submissions and communicate with the research team.
• Report and complete serious adverse events and/or safety logs.
• Communicate with sponsors, monitors and research personnel to ensure all aspects of study compliance.
• 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.
• Schedule pre-site selection visits, site initiation visits, webinars, monitoring and close‑out visits.
• Plan, conduct and evaluate project protocols and research subject recruitment.
• Monitor and report project status and research data.
• Complete regulatory documents, data capture, monitoring plans and protocol‑related activities.
• Assist with preparing and responding to audits and maintaining research tools.
• May assist in the development and maintenance of research tools, such as spreadsheets, questionnaires and/or brochures.
• Document 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.
• Perform other duties as assigned.

Job description

At Cleveland Clinic Health System, we believe in a better future for healthcare. And each of us is responsible for honoring our commitment to excellence, pushing the boundaries and transforming the patient experience, every day.

We all have the power to help, heal and change lives - beginning with our own. That's the power of the Cleveland Clinic Health System team, and The Power of Every One.

Job Title

Research Coordinator II - Digestive Disease Institute

Location

Cleveland

Facility

Cleveland Clinic Main Campus

Department

DDSI Clinical Research Unit-Digestive Disease Institute

Job Code

T99498

Shift

Days

Schedule

8:00am-5:00pm

Job Summary

Job Details

Join Cleveland Clinic's Main Campus where research and surgery are advanced, technology is leading‑edge, patient care is world class and caregivers are family. Here, you will work alongside a passionate and dedicated team, receive endless support and appreciation, and build a rewarding career with one of the most respected healthcare organizations in the world.

Groundbreaking research and discoveries happen every day at Cleveland Clinic, and each team member contributes to our mission of caring for life, advancing health research, and educating those who serve. As a Research Coordinator II, your role is essential for enrolling patients into clinical trials, conducting study visits, and collecting questionnaires with important study‑related information, with a particular focus on IBD - Inflammatory Bowel Disease (ulcerative colitis, Crohn's disease, etc.). While the numerous responsibilities can sometimes be challenging to juggle, your team will support you in enhancing your skills and exploring new avenues of treatment. Join a culture dedicated to advancing healthcare and making a meaningful impact on patients' lives.

A caregiver in this role works days from 8:00 a.m. -- 5:00 p.m. (may vary)

A caregiver who excels in this role will:

• Coordinate the compliant implementation and conduct of human subject research projects.
• Maintain regulatory documents and binders, conduct data management, complete IRB submissions and communicate with the research team.
• Report and complete serious adverse events and/or safety logs.
• Communicate with sponsors, monitors and research personnel to ensure all aspects of study compliance.
• 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.
• Schedule pre-site selection visits, site initiation visits, webinars, monitoring and close‑out visits.
• Plan, conduct and evaluate project protocols and research subject recruitment.
• Monitor and report project status and research data.
• Complete regulatory documents, data capture, monitoring plans and protocol‑related activities.
• Assist with preparing and responding to audits and maintaining research tools.
• May assist in the development and maintenance of research tools, such as spreadsheets, questionnaires and/or brochures.
• Document 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.
• Perform other duties as assigned.

Minimum qualifications for the ideal future caregiver include:

• High School Diploma or GED and three years of experience as a Research Coordinator I or performing the role of a Research Coordinator I
• OR Associate's or Bachelor's degree in health care or science related and one year of experience as a Research Coordinator I or performing the role of a Research Coordinator I
• Proficiency with a variety of computer-based skills, especially in the use of word processing, spreadsheets, database and presentation software
• Solid written and verbal communication skills

Preferred qualifications for the ideal future caregiver include:

• Associate or Bachelor's degree in health care or science related field
• Prior experience in FDA-regulated clinical trials dealing with INDs/GCP
• Prior experience with IRB submissions (initial, amendments, continuing reviews, closures, etc.)
• Prior experience with compliant clinical trial regulatory binder requirements and continuous improvement
• Prior experience scheduling/completing clinical trial study visits/continuous education of patients in the processes of research/adherence to protocol
• Prior experience with the informed consent process and continuous improvement process

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.

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