Mgr., Clinical Research Qual & Edu

The Manager leads and oversees the Regulatory and Compliance Team and oversees quality and education for the entire URCC NCORP Research Base, a $40M NIH-funded national clinical trial coordinating center overseeing a national network of 800+ community oncology practices. The Research Base is part of the Department of Surgery, Division of Supportive Care in Cancer, with offices located in the Saunders Research building. This role is required to be in-office, with work hours/availability during standard business hours, within approximately 8:00 am – 5:00 pm.

Responsibilities

Leads and oversees the Regulatory and Compliance Team; Oversees quality and education for the entire URCC NCORP Research Base; Develops and tracks quality metrics to identify areas needing procedural changes and/or supplemental education; Serves as the senior regulatory and compliance leader for the URCC NCORP Research Base; Directly supervises Regulatory Specialists, Quality Assurance Specialists, Program Compliance Specialists, and Staff developing Training Programs; Leads the Research Base audit and monitoring program; Serves as the NCORP Research Base Data Safety Monitor

Requirements

Bachelor's degree and 7 years of relevant experience; CCRP - Certified Clinical Research Professional within 1 year; SOCRA - Certification In Clinical Research within 1 year

Nice to have

Master's degree preferred; 5 years of progressively responsible work experience in the administrative management of clinical research staff preferred; Proficiency in medical terminology, the clinical research process and applicable regulatory guidelines and standards preferred; Proficiency in managing multiple and competing priorities/demands 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; Fully adheres to applicable safety and/or infection control standards preferred; Exceptional interpersonal, organizational, and time management 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; Possesses a high degree of self-motivation preferred; Recognized ability to function independently preferred