Clin Research Reg Spt Spec II

Job Location: 601 Elmwood Ave, Rochester, New York, United States, 14642

Full-time, 40 scheduled weekly hours

Compensation Range: $25.14 - $35.24 per hour

Responsibilities

• Coordinates and oversees regulatory requirements of clinical research protocols.
• Develops increased learned skills and flexibility in performing duties, assuming 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 and 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 Informed Consent Form (ICF) and inserts institutional language, ensuring consistency 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 and 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 and 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 the same field and participates in protocol-related training as required.
• Performs 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.