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Clin Research Reg Spt Spec II

urmc.rochester.edu Logo

University of Rochester

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Location:
United States of America , Rochester

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Contract Type:
Not provided

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Salary:

24.91 - 34.87 USD / Hour

Job Description:

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 Responsibility:

  • Responsible for the coordination and oversight of regulatory requirements of clinical research protocols
  • Develops increased learned skills, flexibility in performing duties, and assumes responsibility for a portfolio of clinical research protocols under the direction of the Principal Investigator (PI) and senior leaders
  • Prepares all regulatory documentation, document filing, tracking, and maintenance
  • 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

Requirements:

  • 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
  • Ability to effectively manage a higher volume of protocols 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
  • 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

Additional Information:

Job Posted:
February 20, 2026

Employment Type:
Fulltime
Work Type:
On-site work
Job Link Share:

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