"Regulatory Affairs Coordinator (Open Rank: Entry - Senior)"

Regulatory Affairs Coordinator (Open Rank: Entry - Senior)

University of Colorado Anschutz Medical Campus

Department: Neurology

Job Title: Regulatory Affairs Coordinator (Open Rank: Entry - Senior)

Position #: 00845718 - Requisition #39225

Job Summary:

The Department of Neurology has an immediate opening for a full-time Regulatory Affairs Coordinator. The position will independently maintain and manage all IRB and regulatory processes for multi-site sponsored research studies relying on a central IRB. Primary duties will include, but not be limited to: submissions to the Institutional Review Board (IRB) of record including amendments, unanticipated problems, continuing reviews, and study closures; maintenance of the investigator site file/regulatory binder and all essential documents including documentation of appropriate training and delegation for all personnel; submissions to internal University and Hospital research portals; acting as primary regulatory contact person for sponsors/Contract Research Organizations (CROs)/coordinating centers; and training UCD Neurology Clinic Research personnel to promote good clinical practice (GCP) and compliance with all applicable regulations. The Regulatory Affairs Coordinator will work closely with the Senior Clinical Research Regulatory Manager, subspecialty program managers, and clinical research coordinators.

Key Responsibilities:

• Facilitate completion of initial essential regulatory documents (FDA 1572, Financial Disclosure forms, PI signature pages, etc)
• Create/organize regulatory binder and/or electronic files for new studies and maintain regulatory binder and/or electronic files throughout the course of the study, file/update all required documents and ongoing training/certifications appropriately
• Oversee training logs and delegation of duties logs, working with study coordinator to ensure completion prior to enrollment and ongoing accurate maintenance throughout the study
• Maintain documentation of all relevant training
• Prepare for and manage regulatory portion of industry study monitor visits, addressing all regulatory action items
• Create informed consent documents for new studies and update informed consent documents as needed throughout the study
• Facilitate process for investigator receipt and evaluation of external IND safety reports
• Other duties as assigned

Work Location:

Hybrid - this role is eligible for a hybrid schedule of 3 days per week on campus and as needed for in-person meetings.

Why Join Us:

The University of Colorado Anschutz Medical Campus is the largest academic health center in the Rocky Mountain region at the forefront of transformative education, science, medicine, and healthcare. The campus includes the University of Colorado health professional schools, multiple centers, and institutes and two nationally ranked hospitals, UCHealth University of Colorado Hospital and Children's Hospital Colorado, which treat nearly 2 million patients each year. All interconnected, these organizations collaboratively improve the quality of patient care they deliver, research they conduct and health professionals they train.

Why work for the University?

We have AMAZING benefits and offer exceptional amounts of holiday, vacation and sick leave! The University of Colorado offers an excellent benefits package including:

• Medical: Multiple plan options
• Dental: Multiple plan options
• Additional Insurance: Disability, Life, Vision
• Retirement 401(a) Plan: Employer contributes 10% of your gross pay
• Paid Time Off: Accruals over the year
• Vacation Days: 22/year (maximum accrual 352 hours)
• Sick Days: 15/year (unlimited maximum accrual)
• Holiday Days: 15/year
• Tuition Benefit: Employees have access to this benefit on all CU campuses
• ECO Pass: Reduced rate RTD Bus and light rail service

There are many additional perks & programs with the CU Advantage.

Qualifications:

Minimum Qualifications:

Entry Professional:

• A bachelor's degree in public health, public administration, social/behavioral sciences, physical sciences, nursing, healthcare, or a directly related field from an accredited institution
• Substitution: A combination of education and related technical/paraprofessional experience may be substituted for the bachelor's degree on a year for year basis.

Intermediate Professional:

• A bachelor's degree in public health, public administration, social/behavioral sciences, physical sciences, nursing, healthcare, or a directly related field from an accredited institution
• Substitution: A combination of education and related technical/paraprofessional experience may be substituted for the bachelor's degree on a year for year basis.
• One (1) year professional experience in a clinical research setting with regulatory responsibilities

Senior Professional:

• A bachelor's degree in public health, public administration, social/behavioral sciences, physical sciences, nursing, healthcare, or a directly related field from an accredited institution
• Substitution: A combination of education and related technical/paraprofessional experience may be substituted for the bachelor's degree on a year for year basis.
• Two (2) years of regulatory experience (central IRB or local IRB)

Applicants must meet minimum qualifications at the time of hire.

Preferred Qualifications:

• Experience working with Principal Investigators (PIs)
• 1 year Project Management experience
• 3 years of regulatory experience
• IRB experience (COMIRB or central IRB, such as WCG or Advarra)
• Protocol writing
• Experience with University of Colorado/UCHealth systems (Colorado Multiple Institutional Review Board, UCHealth Research Administration, Oncore, InfoED, and Neurology NeuroCRAFT, Veeva).
• Experience with clinical trial management systems and web-based protocol submission systems.
• Experience with administrative duties, such as drafting documents and correspondence, preparing reports, proofreading, operating general office equipment (i.e. copy machine, fax machine, scanner)

Knowledge, Skills and Abilities:

• Experience working with Principal Investigators (PIs)
• 1 year Project Management experience
• 3 years of regulatory experience
• IRB experience (COMIRB or central IRB, such as WCG or Advarra)
• Protocol writing
• Experience with University of Colorado/UCHealth systems (Colorado Multiple Institutional Review Board, UCHealth Research Administration, Oncore, InfoED, and Neurology NeuroCRAFT, Veeva).
• Experience with clinical trial management systems and web-based protocol submission systems.
• Experience with administrative duties, such as drafting documents and correspondence, preparing reports, proofreading, operating general office equipment (i.e. copy machine, fax machine, scanner)

Conditions of Employment:

• Willing and able to work occasional extended hours to meet work location needs

Anticipated Pay Range:

• Entry Professional: $50,996 - $64,867
• Intermediate Professional: $55,495 - $70,590
• Senior Professional: $59,995 - $76,314

The above salary range (or 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.