Clin Rsearch Reg Spt Spc II

University of Rochester • City of Rochester, NY

6d • $52,300 - $73,300 • Onsite

About The Position

The Clinical Research Regulatory Support Specialist II oversees research activities at affiliated National Community Oncology Research Program (NCORP) sites nationwide, ensuring compliance with Research Base standard operating procedures, approved clinical research protocols, Clinical Trials Monitoring Branch (CTMB) guidelines, and federal regulations. The role serves as Lead Auditor for the NCORP Research Base and works with the Manager, Clinical Research Quality & Education on quality assurance and auditing activities. The program supports multi-site cancer control and cancer care delivery clinical trials across a national network of more than 800 community oncology practices, with a portfolio of prospective, cohort, and longitudinal Phase II–III randomized clinical trials.

The specialist develops and updates SOPs, independently creates training and educational materials, and maintains spreadsheets tracking program metrics. The role educates Research Base personnel and external scientific collaborators on quality assurance practices and regulatory compliance, and may provide coverage for the manager and Regulatory Specialists. It also supports regulatory submissions and Data Safety Monitoring Committee reporting.

This is an in-office position in the Saunders Research building, with availability during standard business hours, approximately 8:00 a.m. to 5:00 p.m. Occasional work outside standard business hours may be required. Travel is currently limited to approximately one or two meetings or conferences annually, though travel for on-site monitoring visits may be needed when remote inspection is not possible.

Requirements

• Bachelor's degree and one year of relevant experience, or an equivalent combination of education and experience.
• Five years of experience in clinical trials research and at least three years of experience in monitoring, auditing, quality assurance, or quality improvement.
• Knowledge of Good Clinical Practice, clinical trial protocol planning, implementation, coordination, evaluation, and reporting is strongly preferred.
• Ability to adhere to applicable safety and infection control standards.
• Understanding of and adherence to data integrity standards and processes.
• Fluency in English and excellent written and verbal communication skills; professionalism when interacting with faculty, leadership, and research personnel.
• Proficiency in Microsoft Office, including Word, Excel, and PowerPoint, as well as email and internet use is preferred.
• Work in the office during standard business hours, approximately 8:00 a.m. to 5:00 p.m.; occasional work outside those hours may be required.
• Some travel may be required, including approximately one or two meetings or conferences annually and potential on-site monitoring visits when remote inspection cannot be completed.

Nice To Haves

• Master’s degree with major coursework in an appropriate health, social, or technical field.
• Ability to manage a higher volume of protocols and moderately complex research protocols or procedures.
• High degree of self-motivation and ability to function independently.
• Proficiency in managing multiple and competing priorities.
• Strong attention to detail in recordkeeping and research documentation.
• Thorough knowledge and established track record in assuring GCP, Responsible Conduct of Research standards, applicable safety standards, and OSHA guidelines throughout study implementation.
• Strong interpersonal, communication, and organizational skills.
• Ability to build collaboration among research team members, laboratory staff, patients and families, and clinical services, with tact, sensitivity, clarity, flexibility, and empathy.
• Demonstrated leadership skills and knowledge of clinical research protocol planning, implementation, coordination, evaluation, and reporting.
• Proficiency in medical terminology, clinical research processes, and applicable regulatory guidelines and standards.
• Clinical research certification from an accredited organization, such as ACRP or SOCRA.

Responsibilities

• Establish and coordinate monitoring visit schedules for more than 30 off-site NCORP affiliates in accordance with CTMB Guidelines; notify sites, assemble audit teams, arrange visit details, and prepare audit materials.
• Review regulatory documentation, informed consent forms, drug accountability records, and selected subject cases before audits.
• Lead remote and in-person audits of affiliate sites to assess compliance with NCI and CTMB guidelines and Good Clinical Practice (GCP).
• Verify regulatory documentation and informed consent requirements, pharmacy operations and recordkeeping, drug accountability and inventory control, and source data compliance with protocol requirements.
• Prepare quality assurance and regulatory documentation, including SOPs, spreadsheets, process documents, training materials, and summary documents.
• Serve as backup for the Data Safety Coordinator and assist with preparing and reviewing study progress reports for the Data Safety Monitoring Committee.
• Support Regulatory Specialists and provide regulatory backup for submissions of new concepts, new protocols, protocol amendments, annual IRB renewals, study closures, and reportable events to the NCI and/or IRB, as applicable.
• Provide coverage for the Manager, Clinical Research Quality & Education and Regulatory Specialists as needed.
• Perform other duties as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level