Clinical Research Regulatory Coordinator III - University of Rochester

GENERAL PURPOSE: The Clinical Research Regulatory Coordinator (CRRC) III is an experienced Clinical Research Professional responsible for providing leadership in planning, implementing, monitoring, and evaluating multiple clinical research protocols. Under the ultimate responsibility of the Principal Investigator (PI) and/or Clinical Research Regulatory Manager, the CRRC III is responsible for performing the regulatory requirements of clinical research protocols and the day to day operations of the start-up or maintenance phase of all assigned protocols. S/he will monitor and maximize adherence to research standards, regulatory guidelines, and approved operational procedures; work closely with study team members and other staff/faculty/study sites to ensure regulatory compliance. S/he will mentor less experienced Clinical Research Regulatory Coordinators and participate in the broader CTO operations and objectives. JOB DUTIES AND RESPONSIBILITIES: 1. Prepares all regulatory documentation, document filing, tracking and maintenance. Responsibilities include: Study Start-Up: + Documents new study in REDCap tracking system. Maintains all logs, including OnCore system, according to University of Rochester (UR) and department Standard Operating Procedures (SOPs). Collects all regulatory documents required to submit to the Disease Working Group (DWG) and Protocol Review & Monitoring Committee (PRMC) and collates essential regulatory documents within Complion system. Prepares/drafts Informed Consent Form (ICF) and inserts institutional language; ensuring language 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 Manager. Prepares and tracks/guides submission to Institutional Review Board (IRB) (CIRB, RSRB, Commercial IRB), FDA, ClinicalTrials.gov, etc. Study Maintenance: + 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. Communication and liaison with study team, Sponsors and all stakeholders: Responsibilities include: Study Start-Up: + Liaises with Sponsor regarding activation requirements and timelines. Liaises with other required stakeholders and committees (HURC, IBC, Cell lab/BMT Nurse Manager, Faculty, DWG, etc.). Coordinates official internal activation. Study Maintenance: + Informs study coordinators and physicians when re-consents are required. + Liaises with Sponsor regarding maintenance of protocols. Assists in training less experienced research personnel in research competencies, UR and department SOPs and protocol specific training. Assumes the trainer role for proficiency in use of UR-specific research software needed for their clinical research studies. 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. Professional Development: + Obtains and/or maintains clinical research certification. + 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 **QUALIFICATIONS:** Bachelor's Degree required or equivalent combination of education and experience. 3 years clinical research or relevant work experience required or equivalent combination of education and experience. Fluent English language skills (oral and written) required. Preferred knowledge, skills and abilities: Ability to mentor and provide training to junior members of the team; Ability to effectively manage moderately complex research protocols/procedures; Possesses a high degree of self-motivation; recognized ability to function independently; Proficient in managing multiple and competing priorities/demands; Detailed-oriented in record keeping and research documentation; Fully adheres to applicable safety and/or infection control standards; Understands and follows data integrity standards and processes; Thorough knowledge of and established track record in assuring GCP, Responsible Conduct of Research standards, applicable safety standards, OSHA guidelines, throughout study implementation; Strong interpersonal, communication (verbal and written), and organizational skills; Ability to build collaboration among research team members, laboratory staff, patients and families, clinical services (requires tact, sensitivity, clarity, flexibility, empathy for patients); Proficient in MS Office (e.g. Word, Excel, and PowerPoint), email, internet. Clinical Research Certification by the Association of Clinical Research Professionals (ACRP) required or Society of Clinical Research Associates (SOCRA) or Certification in Healthcare Research Compliance (CHRC) (or obtain certification within 12 months of appointment). The University of Rochester is committed to fostering, cultivating, and preserving a culture of equity, diversity, and inclusion to advance the University’s mission to Learn, Discover, Heal, Create – and Make the World Ever Better. In support of our values and those of our society, the University is committed to not discriminating on the basis of age, color, disability, ethnicity, gender identity or expression, genetic information, marital status, military/veteran status, national origin, race, religion/creed, sex, sexual orientation, citizenship status, or any other status protected by law. This commitment extends to the administration of our policies, admissions, employment, access, and recruitment of candidates from underrepresented populations, veterans, and persons with disabilities consistent with these values and government contractor Affirmative Action obligations. **How To Apply** All applicants must apply online. _EOE Minorities/Females/Protected Veterans/Disabled_ **Location:** School of Medicine & Dentistry **Full/Part Time:** Full-Time **Opening:** Full Time 40 hours Grade 053 Cancer Center/Clin Trials Office