Responsibilities:

• Develops, implements, manages and maintains operational systems and activities.

• Serves as a liaison with all levels of the organization and outside community.

• Manages multiple priorities and projects with competing deadlines.

• Allocates time to meet completion requirements.

• Serves as a coach and mentor for other positions in the department.

• Reviews and monitors adherence to Human Resources policies and corporate compliance procedures.

• Responds to inquiries regarding research studies involving human subjects.

• Develops and presents comprehensive training programs for researchers conducting human subject research studies, including specialization in specific study types

• Leads project related to human subjects research compliance, including preparation and maintenance of educational materials/resources and standard operating procedure development

• Works with Investigators to open, close, or transfer IRB protocols, review appropriate data storage, and provide consultation regarding applicable legal agreement.

• Assists with questions involving ClinicalTrials.gov and monitors for compliance

• Tracks elements of the Institute's human subjects research program, including IRB approved projects, training, protocol deviations, etc.

• Documents risk mitigation efforts, generates metrics, and assists with drafting reports.

• Assists with preparation for and response to audits

• Acts as human subjects research education liaison with local and remote research locations

• Leads meetings, organizes meeting agendas and supporting materials, and records meeting minutes in a timely manner.

• Assists with maintaining an up-to-date website and on-boarding platforms

• Other duties as assigned.

Education:

• Bachelor's degree in Business Administration, Healthcare Administration or related field.

• Master's degree preferred.

Certifications:

• May be required for specific positions as per policy or regulation.

Complexity of Work:

• Requires critical thinking skills, decisive judgment and the ability to work with minimal supervision.

• Must be able to take appropriate action in a stressful environment.

• Demonstrated team, leadership, organizational, financial management and problem solving skills.

• Knowledge of statistical and financial analysis, primary research and business plan development.

• Strong presentation, communication and training skills required for most positions.

Work Experience:

• Minimum of five years of related experience; healthcare setting preferred.

• Offset: Master's degree and four years of experience.

Preferred Qualifications:

• Five years minimum experience conducting and/or managing human subjects research studies preferred.

• Significant knowledge of current regulations related to human subjects research and research compliance preferred.

• Experience working with databases, writing standard operating procedures or other technical documentation preferred.

• Experience developing and giving presentations and providing training, which requires ability to present in a classroom or virtual setting (public speaking skills) preferred.

Physical Requirements:

• Ability to communicate and exchange accurate information.

• Ability to perform work in a stationary position for extended periods.

• Ability to work with physical records or operate a computer or other office equipment.

• In some locations, ability to travel throughout the hospital system.

• In some locations ability to move up to 25 lbs.

Personal Protective Equipment:

• Follows Standard Precautions using personal protective equipment as required for procedures.

Pay Range

Minimum hourly: $33.46

Maximum hourly: $51.03

The pay range displayed on this job posting reflects the anticipated range for new hires. While the pay range is displayed as an hourly rate, Cleveland Clinic recruiters will clarify whether the compensation is hourly or salary. A successful candidate's actual compensation will be determined after taking factors into consideration such as the candidate's work history, experience, skill set, and education. This is not inclusive of the value of Cleveland Clinic's benefits package, which includes among other benefits, healthcare/dental/vision and retirement.

Cleveland Clinic Health System is pleased to be an equal employment employer: Women / Minorities / Veterans / Individuals with Disabilities