Manager, Regulatory Support

Core Job Summary

The Manager, Regulatory Support establishes, manages, and meets the milestones of clinical studies in compliance with applicable clinical and regulatory standards related to human subject protocols. This role ensures training and mentoring of all RSQA clinical research monitors. Additionally, the incumbent provides clinical monitoring oversight for CRO vendors.

Core Job Functions

• Oversees a team of RSQA clinical research monitors for investigational site monitoring and study activities.
• Identifies study issues and implements solutions, including identifying and involving the appropriate decision-makers.
• Anticipates data needs and implements tools for effective study management.
• Assists in database design and data reports.
• Facilitates the development of site training documentation and materials.
• Assists in the creation and maintenance of print and web-based policy and procedure manuals.
• Contributes to the development and writing of clinical protocols, case report forms, and other study documents for investigational studies.
• Counsels on quality control and regulatory issues to research sites and investigators via on-site visits.
• Evaluates quality and completeness of data, and participant safety documentation, and ensures compliance with research regulations and protocols.
• Maintains records of monitoring activities, and prepares reports, responses, and follow-up activities.
• Generates monitoring reports and follow up letters of findings, and tracks corrections to resolution.
• Provides expert consultation on quality control and regulatory issues to research sites and investigators via on-site visits.
• Advises appropriate institutional officials of deficiencies and recommends necessary corrective actions, with follow up to ensure that needed actions have been implemented.
• Conducts internal and external audit preparations.
• Remains in compliance with federal, state, and local regulations, and extramural agencies' requirements.
• Assists with the preparation and presentation of educational programs to groups and individuals in the University research community.
• Provides regulatory support to principal investigators and research teams.
• Assists in the creation and maintenance of a CAPA (corrective action preventive action) system.
• Maintains RSQA related databases, and electronic and paper audit files.
• Assists with the preparation of annual reports of RSQA, summarizing efforts taken and changes to be implemented at both University and department levels.
• Establishes and continuously assesses the effectiveness of the internal controls within the unit and compliance with University policies and procedures.
• Ensures employees are trained on controls within the function and on university policy and procedures.

Core Qualifications

• Education: Bachelor’s degree in relevant field required.
• Experience: Minimum 5 years of relevant experience required.
• Knowledge, Skills and Abilities:
  • Operational Management: Optimizes day-to-day operations and processes for efficiency and effectiveness.
  • Organizational Development: Ability to implement strategies to improve organizational effectiveness, engagement, and manage change.
  • Financial Oversight: Knowledge of financial operations and management.
  • Team Leadership: Ability to create and maintain a cohesive and productive team environment, build positive working relationships and work collaboratively with others.
  • Technical Proficiency: Skilled in using office software, technology, and relevant computer applications.
  • Communication: Strong verbal and written communication skills to convey ideas clearly and persuasively.

Pay

The University of Miami offers competitive salaries and a comprehensive benefits package including medical, dental, tuition remission and more.

Schedule

Full time Employee Type: Staff