University of Rochester · 3 hours ago
Clin Research Reg Spt Spec II
Rochester, New York Metropolitan Area
Full-time
Onsite
Entry Level
$24.91/hr - $34.87/hr
1+ years expThe University of Rochester is dedicated to a culture of equity and accountability and is seeking a Clinical Research Regulatory Support Specialist II. This role involves coordinating and overseeing regulatory requirements for clinical research protocols while ensuring compliance with Good Clinical Practice and federal regulations.
Health CareMedicalUniversities
Responsibilities
Responsible for the coordination and oversight of regulatory requirements of clinical research protocols
Prepares all regulatory documentation, document filing, tracking, and maintenance
Documents new study in tracking system
Maintains all logs, including OnCore, according to University of Rochester (UR) and department Standard Operating Procedures (SOPs)
Collects all regulatory documents required to submit to the DWG and PRMC and collates essential regulatory documents within Complion
Prepares/drafts ICF and insert institutional language, ensuring language is consistent with protocol
Enters and loads all required documents to OnCore and Complion
Coordinates and validates the delegation log with the applicable DWG clinical research staff
Prepares and tracks submission to Institutional Review Board (IRB) (CIRB, RSRB, Commercial IRB), FDA, ClinicalTrials.gov, etc
Maintains regulatory records and necessary correspondence records
Submits IRB approval letters and approved consent forms to sponsors as required to ensure studies remain active
Prepares all protocol annual reviews, addenda, revisions, memos, safety reports, and consent form revisions for submission to the regulatory committees
Assists with coordinating center functions as they relate to on-site and other site(s) participation in clinical trials and affiliate participation
Prepares, submits, tracks, and responds to all regulatory (FDA and IRB) requirements, including safety and ongoing reporting for other participating site(s)
Prepares and submits progress reports and renewals to the IRB and sponsors
Acts as a liaison with study team, sponsors, and all stakeholders
Liaises with sponsor regarding activation requirements and timelines
Liaises with other required stakeholders and committees, such as HURC, IBC, Cell lab/BMT Nurse Manager, Faculty, DWG, etc
Coordinates official internal activation
Informs study coordinators and physicians when re-consents are required
Liaises with Sponsor regarding maintenance of protocols
Assists Clinical Research Coordinators and investigators with study document management and tracking
Complies with Good Clinical Practice and the Code of Federal Regulations
Keeps current with all federal, state, sponsor, and institutional policies and laws, standard operating procedures, and guidelines
Keeps current with industry standards, best practices, and trends in therapeutic areas relevant to research studies
Maintains requisite skills and mandatory training in safety, equality, responsible conduct of research, continuing education, and research competencies
Maintains CITI and Conflict of Interest (COI) certification and renewal as required
Gains knowledge in medical research terminology
Continues to gain proficiency in UR-specific research software needed to manage clinical research protocols
Assumes personal responsibility for keeping up with new developments in the field, related literature, and relevant clinical standards
Assists in helping others in same
Participates in protocol-related training as required
Other duties as assigned
Qualification
Required
Bachelor's degree and 1 year of relevant experience required
Or equivalent combination of education and experience
Fully adheres to applicable safety and/or infection control standards required
Understands and follows data integrity standards and processes required
Preferred
Ability to effectively manage a higher volume of protocols
Ability to effectively manage moderately complex research protocols/procedures
Possesses a high degree of self-motivation
Recognized ability to function independently
Proficient in managing multiple and competing priorities/demands
Detailed-oriented in record keeping and research documentation
Thorough knowledge of and established track record in assuring GCP, Responsible Conduct of Research standards, applicable safety standards, OSHA guidelines, throughout study implementation
Strong interpersonal, communication, and organizational skills
Ability to build collaboration among research team members, laboratory staff, patients and families, clinical services (requires tact, sensitivity, clarity, flexibility, empathy for patients)
Proficient in MS Office (e.g. Word, Excel, and PowerPoint), email, internet
Company
University of Rochester
The University of Rochester is a private research university located in Rochester, New York.
10001+ employees
Funding
Current Stage
Late StageTotal Funding
$20.43MKey Investors
National Science FoundationUnitedHealthcareSociety to Improve Diagnosis in Medicine
2023-09-25Grant· $18M
2023-07-26Grant· $0.07M
2022-09-20Grant· $0.05M
Leadership Team
David Linehan
Chief Executive Officer
Recent News
2025-12-04
Company data provided by crunchbase