Clinical Research Regulatory Specialist II

Benefits

Qualifications

• •Liaises with other required stakeholders and committees, such as HURC, IBC, Cell lab/BMT Nurse Manager, Faculty, DWG, etc
• •Maintains CITI and Conflict of Interest (COI) certification and renewal as 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
• •Proficient in MS Office (e.g
• •4 more items(s)

Responsibilities

• •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
• •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
• •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
• •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
• •29 more items(s)