Manager, Conflict of Interest (COI) & Research Integrity

UT Health San AntonioSan Antonio, TX
4d

About The Position

Manages the operations of the research conflict of interest and research integrity programs to ensure compliance with federal, state, sponsor, and institutional requirements. Oversees disclosure, review, management, and monitoring of investigator conflicts and supports the research integrity officer. Responsibilities Develops continuous quality improvement strategies for the Research Administration offices’ initiatives and establishes processes that align with research regulatory compliance and accreditation standards and strategic plans. Provides program compliance oversight and guidance relative to research administration and institutional research regulatory compliance and accreditors’ benchmarks, and fiscal and reporting requirements. Develops operational timelines and milestone estimates from teams; coordinates efforts among various stakeholders; coordinates project activities; assigns tasks and provides guidance to personnel responsible for specific functions or phases of a project. Develops and maintains master timetable for research regulatory compliance and accreditation reviews and reporting. Designs and coordinates data collection activities for research regulatory compliance and accreditation reviews across institutional offices and synthesizes information for reporting to regulatory compliance and accreditation bodies. Maintains the Research Administration offices policy library and/or database; ensures Policies are up-to-date, accurate and consistent with easy access for all constituents. Management duties include interviewing, selecting, and training employees; setting and adjusting work schedules; planning and directing work; appraising productivity and efficiency, handling complaints/grievances, and disciplining when necessary. Manages the post-approval monitoring (PAM) program, supervising staff responsible for conducting compliance reviews, assessing adherence to approved protocols and management plans, and communicating findings and corrective actions to investigators and research leadership. Coordinates compliance monitoring, reporting, and continuous quality improvement initiatives, coordinates research regulatory and accreditation programs, implements and administers policies and procedures, and serves as a liaison to faculty and University stakeholders to promote ethical, transparent, and compliant research practices. Manages ongoing research regulatory compliance and accreditation processes for the Research Administration offices. Performs all other duties as assigned.

Requirements

  • Critical Thinking Skills - Ability to arrive at accurate conclusions and solutions by visualizing new potential, and by identifying, defining, and analyzing problems and situations using rational and intuitive processes.
  • The ability to attract and mobilize people’s talents and energy, uniting them around a shared purpose that advances the organization’s goals, supports its people, and strengthens the communities it serves.
  • Ability to shape others’ understanding in ways that capture interest, inform, and gain support.
  • Ability to coordinate the diverse components of the project by quality project planning, execution, and change control to achieve the required balance of time, cost, and quality.
  • Builds and maintains positive working relationships within individual work groups and across departments through open communication and collaboration; works with others to accomplish goals and objectives.
  • Demonstrates a clear understanding of all areas of the business (education, research, clinical care) – customers (students, trainees, faculty, community), resources, educational trends, and new advances – and uses skills in planning, prioritizing, decision-making, and resource allocation to drive desired results.
  • Strong organizational and planning skills.
  • Healthcare privacy and compliance knowledge and experience.
  • Experience conducting privacy and compliance-related investigations.
  • Ability to review, analyze, and interpret regulatory requirements.
  • Ability to collaborate across and within various levels of the organization.
  • Excellent customer service skills and strong willingness to take initiative.
  • Bachelor's Degree in Finance, Business Administration, Healthcare Administration, Health Information Management is required.

Responsibilities

  • Manages the operations of the research conflict of interest and research integrity programs to ensure compliance with federal, state, sponsor, and institutional requirements.
  • Oversees disclosure, review, management, and monitoring of investigator conflicts and supports the research integrity officer.
  • Develops continuous quality improvement strategies for the Research Administration offices’ initiatives and establishes processes that align with research regulatory compliance and accreditation standards and strategic plans.
  • Provides program compliance oversight and guidance relative to research administration and institutional research regulatory compliance and accreditors’ benchmarks, and fiscal and reporting requirements.
  • Develops operational timelines and milestone estimates from teams; coordinates efforts among various stakeholders; coordinates project activities; assigns tasks and provides guidance to personnel responsible for specific functions or phases of a project.
  • Develops and maintains master timetable for research regulatory compliance and accreditation reviews and reporting.
  • Designs and coordinates data collection activities for research regulatory compliance and accreditation reviews across institutional offices and synthesizes information for reporting to regulatory compliance and accreditation bodies.
  • Maintains the Research Administration offices policy library and/or database; ensures Policies are up-to-date, accurate and consistent with easy access for all constituents.
  • Management duties include interviewing, selecting, and training employees; setting and adjusting work schedules; planning and directing work; appraising productivity and efficiency, handling complaints/grievances, and disciplining when necessary.
  • Manages the post-approval monitoring (PAM) program, supervising staff responsible for conducting compliance reviews, assessing adherence to approved protocols and management plans, and communicating findings and corrective actions to investigators and research leadership.
  • Coordinates compliance monitoring, reporting, and continuous quality improvement initiatives, coordinates research regulatory and accreditation programs, implements and administers policies and procedures, and serves as a liaison to faculty and University stakeholders to promote ethical, transparent, and compliant research practices.
  • Manages ongoing research regulatory compliance and accreditation processes for the Research Administration offices.
  • Performs all other duties as assigned.
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