Reg Affairs & Compl Spec II

University of Rochester•City of Rochester, NY

12d•$64,200 - $96,200•Hybrid

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. This position has two main components: 1) guiding investigators on the preparation of regulatory documents for submission to the Food and Drug Administration (FDA) and 2) helping investigators stay compliant with Section 801 of the Food and Drug Administration Amendments Act (FDAAA). The University of Rochester has a strong portfolio of industry sponsored and Sponsor-Investigator research studies. The Regulatory Affairs Specialist is responsible for maintaining a portfolio of regulatory submissions for several aspects of clinical research. Trials of medical therapeutics and diagnostics that are not FDA approved often require additional oversight by the FDA. This position will be responsible for guiding Sponsor-Investigators on the preparation of regulatory documents which are needed before, during and after the conduct of a clinical trial. Clinical research trials are required to be registered and reported in a public database, called ClinicalTrials.gov. This position administers the program to ensure adherence to the Federal regulation relating to the registration and reporting of clinical research across the University of Rochester. This work will involve writing Standard Operating Procedures (SOPs), developing training programs and substantial communication with research program coordinators, research nurses, and/or Principal Investigators (PI) to register, update and report results for all research studies deemed applicable clinical trials. The position requires a well-organized, flexible team player with excellent project management skills, an attention to detail, appreciation of nuance, and the ability to adapt to changing regulations. Reports directly to the CTSI CTSI Director of Regulatory Affairs and Director of Research Services, and is accountable to CTSI leadership for specific assigned projects. Hybrid work environments may be available.

Requirements

Bachelor's degree and 3 years of relevant experience required
Working knowledge of FDA regulations as they relate to the management of submissions for Investigational New Drug applications (21CFR Part 312) and Investigational Device Exemptions (21CFR Part 812)
Understanding of FDA guidance documents and applicability to clinical research.
Ability to identify discrepancies in FDA application documents
A solid understanding of research regulatory requirements is essential and can be demonstrated through experience or education.
Ability to follow multiple, detailed directions.
Knowledge of medical terminology and regulations applicable to clinical trials
Excellent communication skills.
Ability to communicate specific research-focused material to Program Coordinators and/or PIs

Nice To Haves

Master's degree preferred
Prior working experience in data collection methodology preferred
Or equivalent combination of education and experience
Relevant experience in pharmaceutical or medical device industry is a plus
Proficiency with MS Word, Excel and Access preferred.
Proficiency with creating, managing and troubleshooting relational databases is desired but on-site training can be done.
Excellent organizational skills preferred.
Keen ability to proofread and check documents for accuracy as well as consistency preferred.
Must have excellent time management skills including the ability to prioritize time-sensitive tasks preferred.
Certified Clinical Research Professional (CCRP) or Certified Clinical Research Coordinator (CCRC); Regulatory Affairs Certification (RAC) or Registered Quality Assurance professional (RQAP) certification preferred

Responsibilities

Manage multiple initiatives simultaneously and keep current on national regulations and international policies that may affect regulatory affairs.
Initiate and participate in collaborations with key stakeholders within UR and at other academic research institutions relating to best practices, quality improvement projects, SOPs, work processes.
Guide investigators on the preparation of regulatory documents for submission to the Food and Drug Administration (FDA).
Help investigators stay compliant with Section 801 of the Food and Drug Administration Amendments Act (FDAAA).
Maintain a portfolio of regulatory submissions for several aspects of clinical research.
Guide Sponsor-Investigators on the preparation of regulatory documents needed before, during, and after the conduct of a clinical trial.
Administer the program to ensure adherence to Federal regulations for the registration and reporting of clinical research across the University of Rochester.
Write Standard Operating Procedures (SOPs).
Develop training programs.
Communicate with research program coordinators, research nurses, and/or Principal Investigators (PI) to register, update, and report results for all research studies deemed applicable clinical trials.
Provide guidance on interpretation for clinical trials registration requirements, including those of FDAAA, International Committee of Medical Journal Editors (ICMJE), Center for Medicare and Medicaid Services (CMS), and National Institutes of Health (NIH).
Provide guidance and support to the research community regarding the registration and reporting requirements for all clinical research.
Provide one-on-one assistance for investigator-initiated trials requiring results reporting.
Work with investigators to enter information into ClinicalTrials.gov.
Develop and maintain a system to prospectively identify and track studies with required results reporting.
Ensure compliance with registration and results disclosure requirements, and escalate to applicable Research Compliance and/or Institutional Officials according to UR policy.
Develop and conduct educational training programs related to Clinical Trials transparency to investigators, study teams, and institutional leadership on an ongoing basis.
Manage access and maintenance of ClinicalTrials.gov system for UR.
Prepare reports to keep institutional leadership updated via reporting of compliance rates and activities.
Analyze project data and prepare data for reports and presentations inside and outside the institution.
Manage and update the Program’s institutional website to ensure it has the latest information on regulatory requirements, links to recent trainings, and links to relevant publications and websites.
Actively participate and engage in the National Clinical Trials Registration Taskforce.
Actively participate in IND & IDE workgroup.
Develop submission plans, templates and timelines for new Investigational New Drug (IND) applications, Investigational Device Exemptions (IDE) submissions or other similar regulatory applications.
Assist clinical study teams in planning and preparing regulatory submissions, including but not limited to annual reports, amendments and responses to requests for information from regulatory agencies.
Participate in the timely and accurate review of clinical trial documents for completeness and compliance with applicable regulations and guidance documents before submission to the FDA.
Assist in the maintenance and management of regulatory documentation located in internal electronic databases which support regulatory processes.
Update the database on a daily basis and run weekly reports on regulatory metrics.
Work within the URMC intake process for clinician requests to use non-FDA-approved drugs for patient treatment through the Expanded Access pathway.
Reach out to relevant stakeholders for individual contributions to the URMC Expanded Access approval process.
Other responsibilities as assigned.