Senior Clinical Research Regulatory Support 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):

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

Opening:

Worker Subtype:

Regular

Time Type:

Full time

Scheduled Weekly Hours:

40

Department:

400119 Surgery-Cancer Control

Work Shift:

UR - Day (United States of America)

Range:

UR URG 110 H

Compensation Range:

$29.33 - $41.06

Responsibilities:

This position represents the Research Base to all regulatory bodies. The Regulatory Specialist is also responsible for ensuring that the work of over 1000 clinical research professionals, as it pertains to regulatory compliance, is complete, accurate, and done in a timely manner as defined by our research protocols, SOPs, and federal requirements.

The URCC NCORP Research Base is a large, complex, and dynamic operation involving many investigators, cross-functional teams, and laboratories. This program is funded by a $36 million NIH grant and provides the infrastructure to conduct large multi-site cancer control and cancer care delivery clinical trials within our national network. The Research Base’s network is comprised of over 800 community oncology practices and thousands of oncologists, advanced practice providers, pharmacists, administrators, research nurses, clinical research coordinators, data managers, regulatory specialists, and quality assurance staff nationwide. The Research Base portfolio includes prospective, cohort, and longitudinal Phase II – III randomized clinical trials. This position oversees all regulatory submissions and regulatory compliance and requires a high attention to detail.

Some travel may be required but is currently limited to approximately 1 to 2 meetings or conferences annually. Travel may periodically be required to perform on-site monitoring visits throughout our national network if the inspection is unable to be completed remotely.

ESSENTIAL FUNCTIONS

Regulatory Submissions

• 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.

Regulatory Compliance

• 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

Regulatory Liaison

• 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 as the
• Disseminates updates from pertinent meetings to multiple teams within the Research Base and the Division (as needed)
• Oversees, organizes, tracks rostering and membership requests

Regulatory/Auditing/Data Safety and Monitoring Program Responsibilities

• 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.

MINIMUM EDUCATION & EXPERIENCE

• Bachelor's degree and 3 years of relevant experience required
• Or equivalent combination of education and experience

KNOWLEDGE, SKILLS AND ABILITIES

• Fully adheres to applicable safety and/or infection control standards required
• 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

LICENSES AND CERTIFICATIONS

• 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

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.