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Job Location (Full Address):

265 Crittenden Blvd, Rochester, New York, United States of America, 14642

Opening:

Worker Subtype:

Regular

Time Type:

Full time

Scheduled Weekly Hours:

40

Department:

400990 Clin & Trans Science Institute

Work Shift:

UR - Day (United States of America)

Range:

UR URG 111

Compensation Range:

$64,200.00 - $96,200.00

Responsibilities:

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.

Hybrid work environments may be available.

ESSENTIAL FUNCTIONS

• 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-FDAapproved 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.

MINIMUM EDUCATION & EXPERIENCE

• Bachelor's degree and 3 years of relevant experience required
• Master's degree preferred
• Prior working experience in data collection methodology preferred
• Or equivalent combination of education and experience

KNOWLEDGE, SKILLS AND ABILITIES

• 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; preferred.
• 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; preferred.
• 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.
• Ability to follow multiple, detailed directions. Knowledge of medical terminology and regulations applicable to clinical trials preferred.
• Must have excellent time management skills including the ability to prioritize time-sensitive tasks preferred.
• Must have excellent communication skills. Must be able to communicate specific research-focused material to Program Coordinators and/or PIs preferred.

LICENSES AND CERTIFICATIONS

• 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 an inclusive and welcoming culture 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 characteristic protected by federal, state, or local law (Protected Characteristics). This commitment extends to non-discrimination in the administration of our policies, admissions, employment, access, and recruitment of candidates, for all persons consistent with our values and based on applicable law.