Clinical Research Coordinator - PRN

ccf; United States; On-site; USD 60,000 - 85,000; Part time

Job summary

Cleveland Clinic Health System in Cleveland, OH is seeking a Clinical Research Coordinator - PRN to support compliant execution of human subject research at the Cleveland Clinic Main Campus, Cancer Center Research-Cancer Institute.

The role involves coordinating studies, managing regulatory documents, and communicating with sponsors to ensure study integrity and adherence to protocols. This position is on-site with a regular daytime schedule and requires strong organizational skills.

Qualifications

• Minimum two years clinical research or healthcare experience.
• High School Diploma or GED; associate or bachelor’s degree preferred.
• Must complete Human Subjects Research certification within 90 days of hire.

Responsibilities

• Coordinate the implementation and conduct of research projects per protocol.
• Maintain regulatory documents, data management, IRB submissions and communications to the research team.
• Report Serious Adverse Events and/or safety logs as defined per protocol under GCP guidelines.
• Collaborate with study team to plan visits, monitoring, and close-out activities.
• Assist with recruitment planning and informed consent where applicable.
• Develop and maintain knowledge of research protocols and assist audits and response actions.

Skills

Clinical research experience

Data management

Regulatory compliance

IRB submissions

Education

High School Diploma or GED

Associate or Bachelor’s degree in healthcare or science

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

Clinical Research Coordinator - PRN

Location

Cleveland

Facility

Cleveland Clinic Main Campus

Department

Cancer Center Research-Cancer Institute

Job Code

D99967

Shift

Days

Schedule

8:00am-4:30am

Job Summary

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

Job Details

• Assists with the coordination, 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 guidelines as applicable.
• Communicates with sponsors, monitors, research personnel to ensure all aspects of study compliance.
• Collaborates with study team to schedule pre-site selection visits, site initiation visits, webinars, monitoring and close-out visits.
• May collaborate 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.
• Assists with completion of 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.
• 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 customers.
• Documents the education and training of research personnel as needed.
• May participate in the conduct and documentation of the informed consent process.
• May contribute to research project budget development.
• Performs other duties as assigned.

Education

High School Diploma or GED. Associate or bachelor's degree in health care or science related field preferred. Degree may offset experience requirement.

Languages

Language required. Language preferred

Certifications

None required.

Complexity of Work

Requires excellent organizational, written, and verbal communication skills. Must be able to take direction and appropriate action in a stressful environment. 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.

Work Experience

Minimum two years clinical research or healthcare experience required. Associate or bachelor's degree in healthcare or science field may offset 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.

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.

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