Senior Regulatory Affairs and Compliance Specialist

University of Rochester•City of Rochester, NY

2d•$70,600 - $105,800•Onsite

About The Position

The Senior Regulatory Affairs and Compliance Specialist provides strategic oversight of regulatory submissions, compliance, quality systems, and stakeholder engagement for clinical research studies across the University of Rochester. The role directs planning, implementation, coordination, operation, and evaluation of administrative and regulatory requirements for regulatory approval and ongoing maintenance of studies. It ensures adherence to FDA Investigational New Drug (IND) and Investigational Device Exemption (IDE) regulations and coordinates regulatory processes for new and ongoing studies. The position oversees compliance with clinical research procedures and documentation requirements from sponsors and agencies, develops and monitors standard operating procedures (SOPs), and supports audit readiness and corrective and preventive action plans. It works with principal investigators, sponsors, University offices, and administrators on study startup, contracts, negotiations, regulatory updates, and related communications. The specialist also provides leadership for clinical services and investigational products, manages regulatory submissions and ClinicalTrials.gov obligations, analyzes portfolio metrics, supports quality improvement, and develops training and certifications for study personnel.

Requirements

Bachelor's degree and 5 years of research regulatory-related experience, or an equivalent combination of education and experience.
CLASP certification required.
Ability to work with minimal direction and considerable latitude for independent judgment.
Extensive working knowledge of Good Clinical Practice guidelines applicable to study implementation, including developing and interpreting protocols in relation to required regulatory documents.
Ability to stay current with industry standards and federal regulations relevant to sponsored studies.
Excellent verbal and written communication skills.

Nice To Haves

Master's degree preferred.
Strong interpersonal, analytical, spreadsheet development and analysis, and technical skills.
Strong problem-solving ability and ability to work independently and collaboratively within a team.
Strong organizational skills, attention to detail, and ability to manage multiple projects and priorities.

Responsibilities

Coordinate regulatory processes for new and ongoing Sponsor-Investigator studies in accordance with University, state, and federal regulations and guidelines.
Assess study regulatory needs and prepare submissions and documentation for the FDA, ClinicalTrials.gov, institutional ancillary reviews, clinical trial management requirements, NIH certificates of confidentiality, and other agencies as needed.
Conduct orientation meetings with study teams and manage ongoing regulatory requirements, including protocol amendments, annual reports, FDA amendments, reporting requirements, and study closures.
Maintain the regulatory documentation database.
Oversee compliance and effectiveness of clinical research procedures and study documentation requirements across sponsors and agencies.
Ensure ongoing study processes and documentation meet internal and external audit guidelines and that essential regulatory documents are current and available for review.
Track study personnel certifications and central and local laboratory facility certifications.
Serve as primary contact for developing Quality Assurance Unit SOPs and conduct semi-annual SOP audits.
Assist in developing corrective and preventive action plans (CAPA) and submit them to the FDA as required.
Liaise with principal investigators, sponsors, Office of Counsel, ORPA, UR Ventures, and administrators on contract development and negotiations, study startup, and regulatory communications.
Develop and maintain relationships with sponsors, CROs, regulatory agencies, site coordinators, and University clinical and operational departments.
Work with the Director, Office of Regulatory Support, to review regulatory requirements against protocols for new studies as needed.
Handle site interest and qualifications surveys and review or develop new contracts with program senior management.
Provide strategic leadership and oversight for clinical services and investigational products, including adherence to IND, IDE, GCP, and institutional requirements.
Manage the institutional portfolio of Sponsor-Investigator regulatory submissions and ensure compliance with federal ClinicalTrials.gov registration and results-reporting requirements.
Collaborate with stakeholders on best practices and quality improvement projects; provide periodic portfolio metrics and data analysis and consultations from the office.
Build relationships with CRC stakeholders and facilitate consultations across CTSI services as needed.
Monitor changes in federal laws, regulations, and guidelines; communicate updates and guide analysis of their impact on study procedures.
Create training and manage training certifications so study personnel remain current on federal regulations for drugs, devices, and ClinicalTrials.gov reporting.
Take active leadership roles in the National Clinical Trials Registration Taskforce and IND & IDE workgroup.
Perform other duties as assigned.