Regulatory Affairs Coordinator (Open Rank: Entry - Senior)

University of Colorado

1d•Hybrid

About The Position

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.

Requirements

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

Nice To Haves

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)
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)

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