Dir, Research Compliance

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Job Location (Full Address):

220 Hutchison Rd, Rochester, New York, United States of America, 14620

Opening:

Worker Subtype:

Regular

Time Type:

Full time

Scheduled Weekly Hours:

40

Department:

100050 Research & Project Admin

Work Shift:

UR - Day (United States of America)

Range:

UR URG 118

Compensation Range:

$140,350.00 - $210,525.00

Responsibilities:

GENERAL SUMMARY
Provides oversight, administration, and direction for high-risk and high-priority financial research compliance functions. Directs the Office of Research Compliance for clinical research billing compliance, sponsored program financial compliance, and development and oversight of the mandatory certification program for research administrators. Identifies and seeks to improve deficiencies in standard operating procedures and provides strategic direction in the areas noted above. Applies knowledge of federal regulations and University policies to all aspects of the essential tasks.

ESSENTIAL FUNCTIONS

• Supervises staff to review and approve the billing plans/budgets for all clinical research studies and ensure harmonization exists among all study documents.
• Ensures any problematic terms are addressed prior to approval.
• Identifies billing risk areas through consultation with peer institutions, internal knowledge of UR-specific risks, and consultation with UR department study personnel.
• Prepares monthly audit samples of transactions for such identified risk areas.
• Oversees audits on the samples and ensures corrective actions for identified errors are resolved.
• Communicates risk mitigation approach to senior leadership and necessary committees.
• Ensures all study calendars built in the system reflect approved billing plans and are successfully activated before study commencement.
• Communicates with department study personnel to ensure the study records and calendars are in an acceptable condition for such activations.
• Collaborates with leadership regarding strategic initiatives to expand the functionality of systems, including creating prototypes, testing prototypes, launching the final product, and communicating/educating research personnel regarding the initiatives.
• Leads the Continuous Learning for Administrators of Sponsored Programs (CLASP) required educational course for research administrators, including keeping the curriculum/course content current, identifying dates, classrooms, and registration, co-instructing all mandatory modules, scheduling and writing course content.
• Monitors individuals’ compliance with minimum continuing education requirements.
• Leads the periodic detailed analysis and investigative communications and follow-up for deemed sponsored project risk areas.
• Creates mandatory faculty and staff training when necessary.

Other duties as assigned.

MINIMUM EDUCATION & EXPERIENCE

• Bachelor's degree and 10 years of relevant experience required
• Or equivalent combination of education and experience
• 5 years' experience with sponsored programs required
• 3 years' experience as a formal instruction at college level or above required
• Experience in accounting or auditing preferred

KNOWLEDGE, SKILLS AND ABILITIES

• Knowledge of third-party financial compliance regulations for research and clinical trial billing required
• Knowledge of University structure, systems, processes, policies and procedures required
• Excellent communication skills and organization skills required

LICENSES AND CERTIFICATIONS

• Certified Public Accountant (CPA) upon hire preferred or
• Certified Internal Auditor (CIA) upon hire preferred or
• CHC - Certified Healthcare Compliance upon hire preferred or
• CHRC - Certified in Healthcare Research Compliance upon hire preferred

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