Clinical Research Reg Spt Spec I
About The Position
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. Responsibilities: Coordinates and oversees regulatory requirements of clinical research protocols. Prepares all regulatory documentation, document filing, tracking and maintenance. Maintains regulatory records and necessary correspondence records. Prepares all protocol annual reviews, addenda, revisions, memos, safety reports, and consent form revisions for submission to regulatory committees.
Requirements
- Bachelor's degree 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
- Understands and follows simple research protocols and procedures required
- Strong interpersonal, communication, and organizational skills preferred
- Highly collaborative, works well in teams preferred
- Proficient in MS Office (e.g. Word, Excel, and PowerPoint), email, internet preferred
Responsibilities
- Coordinates and oversees 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.
- Prepares/drafts ICF and inserts institutional language, ensuring language consistent with protocol.
- Enters and loads all required documents to OnCore and Complion.
- Coordinates and validates delegation log with the applicable DWG 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, including 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 staff 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.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Number of Employees
5,001-10,000 employees
