PROGRAM DIRECTOR II

General Responsibilities

Directs operations of a programmatic function. Operates with a high degree of independence. Responsible for program development, content and administration. Establishes program objectives, manages programmatic fiscal activities, supervises staff engaged in carrying out program activities and may require grant writing and/or other ability to secure program funding. Prepares various reports for program.

Key Duties & Responsibilities

• Manages research administration activities including preparation, coordination, and submission of grant applications, contract proposals, and supporting documentation.
• Develops budgets, justifications, and sponsor-required materials.
• Oversights regulatory and IRB operations for complex studies, including preparation and submission of IRB applications, modifications, continuing reviews, and reportable events.
• Manages single IRB processes for multi-site studies and serves as primary liaison with relying institutions.
• Ensures compliance with federal, state, and institutional regulations, including NIH, PCORI, FDA, HIPAA, and Good Clinical Practice (GCP) requirements.
• Maintains regulatory documentation such as protocols, consent forms, investigator brochures, and study records.
• Captures and submits progress reports and deliverables, including RPPRs, contract reports, and sponsor-required documentation.
• Tracks deadlines and ensures timely submission of all required materials.
• Prepares and maintains regulatory and clinical research documentation, including IND/IDE applications when applicable, safety reports, delegation logs, and study-specific records in institutional systems (e.g., IRAP, OnCore).
• Serves as liaison between faculty, the Office of Sponsored Programs, IRB, other university offices, and external collaborators to facilitate communication, resolve issues, and ensure alignment with institutional processes and sponsor expectations.
• Maintains study compliance and conducts quality assurance activities, including internal audits of regulatory files and review of study documentation to ensure accuracy and completeness.
• Maintains Other Support documentation and effort reporting for faculty with multiple funded projects and coordinates updates in accordance with sponsor requirements.
• Leads process improvement initiatives to enhance efficiency in research administration and regulatory workflows.
• Develops standard operating procedures and provides recommendations to leadership.

Salary Pay Range

$60,835 – $98,855

Minimum Requirements

• Bachelor's degree in a related field and five (5) years of related experience required.
• Work experience may NOT substitute for education requirement.

Knowledge / Skills / Abilities

• Comprehensive understanding of IRB, human subjects research, and regulatory compliance requirements.
• Familiarity with FDA regulations (IND/IDE) and clinical research documentation.
• Strong organizational, analytical, and problem-solving skills.
• Ability to manage multiple complex projects simultaneously.
• Strong written and verbal communication skills.
• Ability to work independently and collaboratively in a team environment.
• Proficiency in institutional systems and research administration software.
• Demonstrated ability to prioritize and meet deadlines in a fast-paced environment.