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About the Role

The Regulatory Specialist acts as the primary regulatory liaison with agencies such as IRB, government agencies, and Sponsors. This role is responsible for ensuring the work of over 1000 clinical research professionals is compliant, complete, and accurate according to research protocols, SOPs, and federal requirements. The position oversees all regulatory submissions and compliance for a large, complex operation funded by an NIH grant, involving a national network of community oncology practices and thousands of healthcare professionals.

Responsibilities

Acts as primary regulatory liaison with agencies such as IRB, government agencies and Sponsors.
Works closely with Research Base cross-functional teams in preparation of study documents for submissions of new protocols, study protocol amendments, annual continuing reviews of approved studies, as well as unanticipated events to the Sponsor and IRB.
Performs final edits and proofreading of protocol submission package documents.
Prepares and sends protocol documents for submission.
Coordinates, tracks and monitors information regarding protocol submissions and documents required for the NCORP sites.
Reviews regulatory and other site records such as Federal Wide assurance and site level approvals to ensure our clinical research sites and personnel are adhering to Research Base SOPs, the approved clinical research protocol, and to all applicable federal regulations.
Develops and maintains standard operating procedures in collaboration with Program Managers, Administrative leadership, and MPIs of the Research Base.
Updates and maintains ClinicaTrials.gov records.
Updates and maintains conflict of interest records.
Develops, updates and maintains protocol templates.
Acts as regulatory representative for NCORP Research Base as primary point of contact for over 800 community sites across approximately 30 NCORP community partner programs.
Participates in meetings with regulatory/audit team, project teams and Institutional Review Board meetings.
Disseminates updates from pertinent meetings to multiple teams within the Research Base and the Division.
Oversees, organizes, tracks rostering and membership requests.
Perform other project coordination activities as directed by the Program Manager, Administrative leadership, or MPIs of the URCC NCORP Research Base.
Assists or leads sections for URCC NCORP progress report reporting and grant submissions for concepts and the overall URCC NCORP Research Base.
Other duties as assigned.

Requirements

Bachelor's degree and 3 years of relevant experience required or equivalent combination of education and experience.
Fully adheres to applicable safety and/or infection control standards required.
CCRP - Certified Clinical Research Professional by the Association of Clinical Research Professionals (ACRP) within 1 year required or SOCRA - Certification In Clinical Research within 1 year required or CHRC - Certified in Healthcare Research Compliance within 1 year required.

Skills

Ability to mentor and provide training to junior members of the team preferred.
Ability to effectively manage moderately complex research protocols/procedures preferred.
Possesses a high degree of self-motivation preferred.
Recognized ability to function independently preferred.
Proficient in managing multiple and competing priorities/demands preferred.
Detailed-oriented in record keeping and research documentation preferred.
Understands and follows data integrity standards and processes preferred.
Thorough knowledge of and established track record in assuring GCP, Responsible Conduct of Research standards, applicable safety standards, OSHA guidelines, throughout study implementation preferred.
Strong interpersonal, communication, and organizational skills preferred.
Ability to build collaboration among research team members, laboratory staff, patients and families, clinical services (requires tact, sensitivity, clarity, flexibility, empathy for patients) preferred.
Proficient in MS Office (e.g. Word, Excel, and PowerPoint), email, internet preferred.

Location

601 Elmwood Ave, Rochester, New York, United States of America, 14642

Work Type

Full time
Regular

Experience Level

3 years of relevant experience

Education Level

Bachelor's degree

Salary/Compensations

$29.33 - $41.06

About the Company

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.

Equal Opportunity

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.