CTSI Regulatory Affairs & Compliance Specialist II

Rochester, NY

GENERAL PURPOSE:

With minimum direction and considerable latitude for independent judgment, the CTSI Regulatory Affairs Specialist will be expected to manage multiple initiatives simultaneously and to keep current on national regulations and international policies that may affect regulatory affairs. The CTSI Regulatory Affairs Specialist will 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.

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.

Supervision and Direction:

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.

Remote or hybrid work environments may be available.

RESPONSIBILITIES:

  • Using knowledge of applicable laws and regulations, this individual provides 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).

  • Provides guidance and support to the research community regarding the registration and reporting requirements for all clinical research.

  • Provides one-on-one assistance for investigator-initiated trials requiring results reporting. Works with investigators to enter information into ClincalTrials.gov.

  • Develops and maintains a system to prospectively identify and track studies with required results reporting. Ensures compliance with registration and results disclosure requirements, and escalates to applicable Research Compliance and/or Institutional Officials according to UR policy.

  • Develops and conducts 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. Prepares reports to keep institutional leadership updated via reporting of compliance rates and activities. Analyzes project data and prepares data for reports and presentations inside and outside the institution. Manages and updates 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.

National workgroups:

  • Actively participates and engages in the National Clinical Trials Registration Taskforce – a monthly meeting of clinical trial registration experts at Academic Medical Centers (AMC) focusing on clinical trials registration and results reporting issues that affect AMCs. Over time, may take on leadership roles in this group.

  • Actively participates in IND & IDE workgroup – a monthly meeting of regulatory experts from Clinical and Translational Science Award hubs across the nation.

  • Develops submission plans, templates and timelines for new Investigational New Drug (IND) applications, Investigational Device Exemptions (IDE) submissions or other similar regulatory applications. Assists 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. Participates 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.

  • Assists in the maintenance and management of regulatory documentation located in internal electronic databases which support regulatory processes. Updates the database on a daily basis and runs weekly reports on regulatory metrics.

  • Works within the URMC intake process for clinician requests to use non-FDA-approved drugs for patient treatment through the Expanded Access pathway. Reaches out to relevant stakeholders for individual contributions to the URMC Expanded Access approval process.

Other responsibiliites as assigned.

QUALIFICATIONS:

  • Minimum of a bachelor’s degree in one of biological or social sciences, public health or other related discipline required.

  • Master’s degree preferred.

  • Some statistical coursework required and a minimum of three years of experience doing clinical research, working with data collection and analysis. Prior working experience in data collection methodology 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. Relevant experience in pharmaceutical or medical device industry is a plus.

  • (or equivalent combination of education and experience)

  • Proficiency with MS Word, Excel and Access is required. Proficiency with creating, managing and troubleshooting relational databases is desired but on-site training can be done. Excellent organizational skills required. Keen ability to proofread and check documents for accuracy as well as consistency is required. Ability to follow multiple, detailed directions. Knowledge of medical terminology and regulations applicable to clinical trials is required. Must have excellent time management skills including the ability to prioritize time-sensitive tasks. Must have excellent oral and written communication skills. Must be able to communicate specific research-focused material to Program Coordinators and/or PIs.

  • Certified Clinical Research Professional (CCRP) or Certified Clinical Research Coordinator (CCRC); Regulatory Affairs Certification (RAC) or Registered Quality Assurance professional (RQAP) certification preferred.

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

Pay Range

Pay Range: $62,525 - $93,766 Annually

The referenced pay range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job’s compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations.

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