Detailed knowledge of substantial body of regulatory information, including but not limited to OHRP, FDA, HIPPA. Management and training of professional staff with leadership abilities that ensure communication and compliance from all entities. Skilled and well educated in performing audits, needs assessments and use of resources and appropriate resource management. Knowledge and experience with clinical, research reports and regulatory documents.

SCHOOL	MAJOR	YEAR	DEGREE
University of Denver	Legal Affairs in Healthcare Leadership	2018	Master Degree
University of Denver	Communications	2014	Bachelor Degree

Highlights:

Companies I like:

Research Institutions, Clinical Research

• Management
• Policies and Procedures
• Protocol
• Research
• Leadership
• Compliance
• Assessments
• Health Insurance Portability And Accountability Act
• Resource Management
• Training

• Manage day-to-day operations of IRB department including development of policies, procedures, guidance manuals and Federal Wide Assurance compliance • Oversee clinical and behavioral studies for compliance with FDA and OHRP federal regulations • Work directly with principal investigators to ensure protocol compliance • Hire and manage staff including managers, supervisors and analyst team members • Manage educational opportunities, expectations and motivation of staff within their respective roles • Support principal investigators, committees and faculty on interpretation of federal regulations and institutional policies • Establish and maintain IRB agreements and processes that support agreements including SOP development • Direct performance of routine and directed audits and monitoring, investigations of scientific misconduct and other compliance concerns via compliance hotline • Established and implemented compliance hotline resources and oversight • Developed workshop initiatives and performance evaluations • Serve as liaison and report directly to senior leadership and governmental entities • Conduct workshops for investigators and staff of CITI course • Contract administration