Senior Regulatory Affairs and Compliance Specialist

As a community, the University of Rochester is defined by a deep commitment to Meliora - Ever Better. Embedded in that ideal are the values we share: equity, leadership, integrity, openness, respect, and accountability. Together, we will set the highest standards for how we treat each other to ensure our community is welcoming to all and is a place where all can thrive.

Job Location (Full Address):

265 Crittenden Blvd, Rochester, New York, United States of America, 14642

Opening:

Worker Subtype:

Regular

Time Type:

Full time

Scheduled Weekly Hours:

40

Department:

400990 Clin & Trans Science Institute

Work Shift:

UR - Day (United States of America)

Range:

UR URG 112

Compensation Range:

$70,600.00 - $105,800.00

Responsibilities:

Responsible for strategic oversight, complex regulatory submissions and compliance, quality system management, and high-level stakeholder interaction, the Senior Regulatory Affairs and Compliance specialist directs the planning, implementation, coordination, operation, and evaluation of administrative and regulatory requirements leading to regulatory approval and regulatory maintenance of clinical research studies across the university. Ensures strict adherence to FDA Investigational New Drug (IND) and Investigational Device Exemption (IDE) regulations. Coordinates regulatory processes for new and ongoing studies. Oversees compliance with and effectiveness of Clinical Research procedures and study documentation requirements from multiple sponsors and agencies. Establishes and monitors standard operating procedures (SOPs). Liaises with Principal Investigators (PIs), sponsors, and administrators to assist with program contract development, financial negotiations, and sponsor receivables.

ESSENTIAL FUNCTIONS

• Coordinates regulatory processes for new and ongoing SponsorInvestigator studies following university, state and /or federal regulations and guidelines. Evaluates study regulatory needs based on grant requirements and prepares documents and submissions to the FDA and for submission to ClinicalTrials.gov, institutional ancillary review requirements, clinical trial management requirements, National Institutes of Health (NIH) certificates of confidentiality, and other agencies as needed. Conducts orientation meetings with various teams particular to each study. Manages ongoing regulatory requirements for active studies, including but not limited to protocol amendments, annual reports and amendments to the FDA, and oversees study closures. Responsible for reporting requirements. Manages maintenance of regulatory documentation database.
• Oversees compliance with and effectiveness of Clinical Research procedures and study documentation requirements from multiple sponsors and agencies. Ensures process and documentation of ongoing studies meet all internal and external audit guidelines. Ensures regulatory and other essential documents are current and on file for regulatory review. Maintains and tracks study personnel certification and current central and local lab facility certifications. Serves as primary contact for developing Quality Assurance Unit standard operating procedures (SOP). Conducts semi-annual SOP audits to verify procedures and equipment's accuracy and ensure compliance with institutional and sponsor requirements. Assists with developing corrective and preventative action plans (CAPA) and submits to FDA as required.
• Liaises with principal investigators, sponsors, Office of Counsel, ORPA, UR Ventures and administrators to assist with program contract development and negotiations, study startup, and communication of regulatory updates. Develops and maintains relationships with sponsors, CROs, regulatory agencies, site coordinators, and other
• University clinical and operational areas/departments. Works with the Director, Office of Regulatory Support to review regulatory  requirements against protocol on new studies as needed.  Handles site interest/qualifications surveys and reviews/develops new contracts with program senior management. 
• Provides strategic leadership and comprehensive oversight for clinical services and investigational products, ensuring strict adherence to FDA
• Investigational New Drug (IND) and Investigational Device Exemption (IDE) regulations, Good Clinical Practice (GCP) guidelines, and institutional policies. Key responsibilities include: managing institutional portfolio of Sponsor-Investigator regulatory submissions, ensuring adherence to federal regulations regarding ClinicalTrials.gov study registration and results reporting, and collaborating with key stakeholders for best practices and quality improvement projects. Provides periodic metrics and data analysis of all ongoing projects in the portfolio and consultations from the office.
• Develops relationships with CRC stakeholders, understands the range of services and facilitates consultations across a range of CTSI services when needed. Stays abreast of the constantly changing federal laws, regulations and guidelines and communicates new regulatory information to the project team and guides analysis for consideration of impact on study procedures. Creates trainings and manages training certifications for study personnel to ensure team members are current on federal regulations governing drugs, device and study reporting in ClinicalTrials.gov.    
• Takes on active leadership roles in National Clinical Trials Registration Taskforce and IND & IDE workgroup. 
• Other duties as assigned.

MINIMUM EDUCATION & EXPERIENCE

• Bachelor's degree and 5 years research regulatory related experience required
• Master's degree preferred
• Or equivalent combination of education and experience

KNOWLEDGE, SKILLS AND ABILITIES

• Ability to act with minimal direction and considerable latitude for independent judgment required
• Extensive working knowledge of Good Clinical Practice guidelines applicable to study implementation, including development and interpretation of protocol as it relates to the required regulatory documents, required
• Ability to keep current with industry standards and federal regulations relevant to sponsored studies required
• Excellent verbal and writing skills required
• Strong interpersonal, analytical, spreadsheet development and analysis, and technical skills preferred
• Strong problem-solving ability, and ability to work both independently and collaboratively within a team preferred
• Strong organizational skills, attention to detail, and ability to manage multiple projects and priorities preferred

LICENSES AND CERTIFICATIONS

• CLASP certification required

The University of Rochester is committed to fostering, cultivating, and preserving an inclusive and welcoming culture to advance the University’s Mission to Learn, Discover, Heal, Create – and Make the World Ever Better. In support of our values and those of our society, the University is committed to not discriminating on the basis of age, color, disability, ethnicity, gender identity or expression, genetic information, marital status, military/veteran status, national origin, race, religion, creed, sex, sexual orientation, citizenship status, or any other characteristic protected by federal, state, or local law (Protected Characteristics). This commitment extends to non-discrimination in the administration of our policies, admissions, employment, access, and recruitment of candidates, for all persons consistent with our values and based on applicable law.