Research Coordinator II - Digestive Disease Institute

ccf; Cleveland (OH); On-site; USD 60,000 - 76,000; Full time

Job summary

Cleveland Clinic Health System is seeking a Research Coordinator II for the Digestive Disease Institute at the Main Campus in Cleveland. The role focuses on enrolling patients in clinical trials, conducting study visits, and collecting questionnaires related to IBD research.

You will work with a multidisciplinary team, manage regulatory documents, and ensure study compliance across regulatory requirements. This full-time position runs days, with an 8:00am–5:00pm schedule.

Qualifications

• Experience with human subject research projects and regulatory processes.
• Familiarity with IRB submissions and continuing reviews.
• Strong written and verbal communication skills.

Responsibilities

• Coordinate compliant implementation and conduct of human subject research projects.
• Maintain regulatory documents, perform data management, and IRB submissions.
• Monitor safety logs and report serious adverse events.
• Communicate with sponsors, monitors and research staff to ensure study compliance.
• Serve as liaison among investigators, study personnel, and central offices.
• Schedule visits, trainings, and site initiation/monitoring activities.
• Recruit and enroll patients, and collect study questionnaires and data.

Skills

IRB submissions

Data management

Regulatory documentation

Study coordination

Education

Associate's or Bachelor's degree in health care or science related

High School Diploma or GED with 3 years research coordination experience

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.

The policy of Cleveland Clinic Health System and its system hospitals (Cleveland Clinic Health System) is to provide equal opportunity to all of our caregivers and applicants for employment in our drug free environment. All offers of employment are followed by testing for controlled substances.

Cleveland Clinic Health System administers an influenza prevention program. You will be required to comply with this program, which will include obtaining an influenza vaccination on an annual basis or obtaining an approved exemption.

Decisions concerning employment, transfers and promotions are made upon the basis of the best qualified candidate without regard to color, race, religion, national origin, age, sex, sexual orientation, marital status, ancestry, status as a disabled or Vietnam era veteran or any other characteristic protected by law. Information provided on this application may be shared with any Cleveland Clinic Health System facility.

If applying for a Florida position, please see the following website for more information on the background screening requirements required by the Agency of Health Care Administration: https://info.flclearinghouse.com/

Please review the Equal Employment Opportunity poster.

Cleveland Clinic is pleased to be an equal employment opportunity employer.