Program Manager III – LRI Compliance Education Office Human Subjects Research

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.