Regulatory Specialist
University of Colorado Anschutz Medical Campus

Job Info

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Regulatory Specialist - 28905 University Staff

Description
University of Colorado Anschutz Medical Campus

Department: Clinical Research Operations Support

Job Title: Regulatory Specialist

Position: #00806541 – Requisition: #28905

Job Summary:

The Regulatory Specialist will provide regulatory support and expertise throughout the lifecycle of projects that fall under the IND/IDE Office's oversight, primarily in the area of single patient compassionate use requests. However, the individual will have the opportunity to assist with traditional IND and IDE submissions to the FDA as well. The Regulatory Specialist should understand the various stages and components of clinical trials in order to assist in the compilation of complete submission packages to the various branches of FDA and internal institutional entities. This position works directly with the Office's Medical Directors, Principal Investigators (PIs) and collaborates with institutional partners including the Clinical Research Administrative Office, the IRB, and clinical teams.

Key Responsibilities:

• The Regulatory Specialist is primarily responsible for submission of single patient Compassionate Use Requests to various branches of FDA, and to internal entities per institutional policies.
• This position supports the Senior Regulatory Specialist as needed by ensuring all required documentation and sections/modules for submissions to FDA are complete and formatted per FDA requirements.
• This position supports the Senior Regulatory Specialist as needed by identifying missing or incomplete documentation and tracking and managing requests for outstanding documentation.
• Under the guidance of the Senior Regulatory Specialist:
• Meets regularly with the PI and study team to review content and progress of application packages to various branches of FDA
• Manages the submission of expedited and routine reports to FDA,
• Maintains version control for documentation throughout the IND/IDE's life cycle,
• Identifies and elevates barriers delaying any FDA submissions and assists with identifying solutions.
• Participates in process improvement initiatives.
• Assists in developing and providing Standard Operating Procedures, educational resources and training for IND/IDE Office team members and investigators and their research teams.
• Other relevant tasks as delegated by the supervisor or leadership.

Why Join Us:

The Office of Clinical Research Support (CROS) in the Office of the Vice Chancellor for Research (OVCR) at the University of Colorado Anschutz Medical Campus (CU Anschutz) seeks a Regulatory Specialist. CU Anschutz is a large academic medical center located in the Denver Metropolitan area with a sponsored research portfolio of more than $500 million annually. CU Anschutz seeks a qualified candidate to join the newly developed IND/IDE Office. The mission of the office is to facilitate efficient start up processes for investigator-initiated research under FDA oversight, ensure that this research is feasible and appropriately resourced, alleviate administrative burdens on investigators, and mitigate compliance risks for the institution. This will be accomplished by providing robust and tailored centralized support for investigator-initiated submissions to FDA, for projects using drugs, biologics and medical devices.

The University of Colorado offers a comprehensive benefits package that includes health insurance, life insurance, retirement plans, tuition benefits, ECO pass, paid time off – vacation, sick, and holidays and more. To see what benefits are available, please visit: https://www.cu.edu/employee-services/benefits-wellness.

Diversity and Equity:

The University of Colorado Anschutz Medical Campus is committed to recruiting and supporting a diverse student body, faculty, and administrative staff. The university strives to promote a culture of inclusiveness, respect, communication and understanding. We encourage applications from women, ethnic minorities, persons with disabilities, persons within the LGBTQ+ community and all veterans. The University of Colorado is committed to diversity and equality in education and employment.

Qualifications:

Minimum Qualifications:

A bachelor's degree in public health, public administration, social/behavioral sciences, physical sciences, nursing, healthcare, finance, accounting, business administration, business, or a directly related field from an accredited institution. 1 year of professional level clinical trial experience as a coordinator, regulatory staff, or other support position.

A combination of education and related technical/paraprofessional experience may be substituted for the bachelor's degree on a year for year basis.

Applicants must meet minimum qualifications at the time of hire.

Preferred Qualifications:

Experience in clinical trial regulatory work including submissions to institutional regulatory entities (e.g., the Institutional review board) and external entities (e.g., the Food and Drug Administration). Experience with federal regulations and process for submitting INDs and IDEs to the FDA.

Knowledge, Skills, and Abilities:

• Competencies
• Ability to communicate effectively, both in writing and orally.
• Ability to establish and maintain effective working relationships with employees at all levels throughout the institution.
• Outstanding customer service skills.
• Demonstrated commitment and leadership ability to advance diversity and inclusion.
• Able to adapt to ambiguous and/or changing situations and produce results.
• Exceptional attention to detail
• Effective collaboration and facilitation skills
• Self-motivated, willing to act with demonstrated ability to establish relationships.
• Independent judgment, strong organization and communication skills and a superior customer service focus
• Ability to critically assess a program solicitation.
• Ability to work with minimal supervision and as part of a team.
• Strong interpersonal skills (written and verbal) and high degree of professionalism.

How to Apply:

For full consideration, please submit the following document(s):

1. A letter of interest describing relevant job experiences as they relate to listed job qualifications and interest in the position
2. Curriculum vitae / Resume
3. Three to five professional references including name, address, phone number (mobile number if appropriate), and email address

Questions should be directed to: Meggan Schmidt, Meggan.Schmidt@cuanschutz.edu,

Screening of Applications Begins:

Screening of applications begins immediately and will continue until position is filled.

Anticipated Pay Range:

The starting salary range (or hiring range) for this position has been established as $54,960-$69,909.

The above hiring range represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting. This position may be eligible for overtime compensation depending on the level.

Your total compensation goes beyond the number on your paycheck. The University of Colorado provides generous leave, health plans and retirement contributions that add to your bottom line.

Total Compensation Calculator: http://www.cu.edu/node/153125

ADA Statement:

The University will provide reasonable accommodations to applicants with disabilities throughout the employment application process. To request an accommodation pursuant to the Americans with Disabilities Act, please contact the Human Resources ADA Coordinator at hr.adacoordinator@ucdenver.edu​.

Background Check Statement:

The University of Colorado Anschutz Medical Campus is dedicated to ensuring a safe and secure environment for our faculty, staff, students, and visitors. To assist in achieving that goal, we conduct background investigations for all prospective employees.

Vaccination Statement:

The University of Colorado has a requirement for COVID-19 vaccinations and full completion thereof by 9/1/21 or upon start date. Information regarding this requirement, and exemptions can be found at:

Anschutz: https://www.ucdenver.edu/docs/librariesprovider284/default-document-library/3000-general-admission/3012---covid-19-vaccination-requirement-and-compliance.pdf?sfvrsn=4e9df3ba_2

Unit-Specific Exemptions:

• Anschutz Campus – Accommodations may be granted for medical or religious reasons.

The University of Colorado seeks individuals with demonstrated commitment to creating an inclusive learning and working environment. We value the ability to engage effectively with students, faculty, and staff of diverse backgrounds.
Application Materials Required: Cover Letter, Resume/CV, List of References

Job Category: Research Services

Primary Location: Aurora Department: U0001 -- DENVER & ANSCHUTZ MED CAMPUS - 21976 - ADM AVC Clinical Res Operation

Schedule: Full-time

Posting Date: Feb 28, 2023

Unposting Date: Ongoing Posting Contact Name: Meggan Schmidt Posting Contact Email: Meggan.Schmidt@cuanschutz.edu Position Number: 00806541





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