Sr. Clin Research Reg Supt Spec-TAR
University of RochesterAbout the role
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, 14642Opening:
Worker Subtype:
RegularTime Type:
Time as Reported / Per DiemScheduled Weekly Hours:
As Scheduled
Department:
400119 Surgery-Cancer ControlWork Shift:
UR - Day (United States of America)Range:
UR URG 110 HCompensation Range:
$29.33 - $41.06The referenced pay range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job's compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations.
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 o
Apply for this role
Generate a tailored application kit with a matched cover letter, interview prep, and CV highlights — in under 60 seconds.
Apply Now →Generate Application KitFree account required — sign up in 30s