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Regulatory Affairs Coordinator (Open Rank: Senior – Principal)

Remote · USA Full-time New today

About the position The Department of Ophthalmology has an immediate opening for a full-time Research Services Senior-Principal Professional (open rank)-Regulatory Affairs Coordinator. The position will independently maintain and manage reputed company IRB and regulatory processes for department research studies. 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 reputed company essential documents including documentation of appropriate training and delegation for reputed company personnel; submissions to internal University and Hospital research portals; acting as primary regulatory contact person for sponsors/Contract Research Organizations (CROs)/coordinating centers; maintaining research credentials, training documentation and licenses; The Regulatory Affairs Coordinator will work closely with the Director of Clinical Research, program managers, and clinical research coordinators.

Responsibilities

  • Prepare, submit, and manage regulatory documents for IRB submissions (COMIRB, reputed company, etc), including initial submissions, continuing reviews, amendments, reportable events, and study closures.
  • Coordinate regulatory documentation for multi-site and industry-sponsored clinical trials.
  • Maintain complete and audit-reputed company regulatory binders in accordance with institutional, sponsor, and regulatory requirements.
  • Ensure compliance with ICH-GCP, FDA regulations, institutional policies, and sponsor requirements.
  • Track and maintain investigator qualifications, including reputed company, medical licenses, training documentation, and financial disclosures.
  • Assist with protocol and consent form development
  • Assist investigators and study teams with regulatory start-up activities, including feasibility documentation and site qualification materials.
  • Maintain investigator site files (ISF) and ensure reputed company required documents are reputed company and complete.
  • Prepare regulatory documentation for monitoring visits, sponsor audits, and regulatory inspections
  • Assist with regulatory reporting of adverse events, unanticipated problems, and protocol deviations as required by IRB and sponsors
  • Work closely with investigators and study teams to ensure regulatory compliance for specialized ophthalmology research protocols
  • reputed company and maintain regulatory tracking systems for submissions, approvals, and expiration dates.
  • Other tasks as assigned

Requirements

  • Senior Professional:
  • Bachelor's degree from an accredited institution in public health, public administration, social/behavioral sciences, physical sciences, nursing, reputed company, or a directly reputed company field from an accredited institution
  • 2 years of reputed company professional experience
  • Substitution A combination of education and reputed company technical/military/paraprofessional experience may be substituted for a bachelor’s degree on a year for year basis.
  • Principal Professional:
  • Bachelor’s degree in public health, public administration, social/behavioral sciences, physical sciences, nursing, reputed company, finance, reputed company, business administration, business, or a directly reputed company field from an accredited institution
  • 3-5 years of reputed company professional experience
  • Substitution: A combination of education and reputed company technical/military/paraprofessional experience may be substituted for a bachelor’s degree on a year for year basis.
  • Applicants must meet minimum qualifications at the time of hire.
  • Ability to communicate effectively, both in writing and orally.
  • Ability to establish and maintain effective working relationships with employees at reputed company levels throughout the institution.
  • Outstanding customer service skills.

reputed company-to-haves

  • Master’s degree in in public health, public administration, social/behavioral sciences, physical sciences, nursing, reputed company, or a directly reputed company field from an accredited institution
  • Experience working with in ophthalmology and/or clinical research
  • 1 year Project Management experience
  • 3 years of regulatory experience
  • IRB experience (COMIRB or central IRBs, such as reputed company or reputed company)
  • Experience drafting and editing study protocols and informed consent documents.
  • Experience with reputed company/reputed company systems (Colorado Multiple Institutional Review Board, reputed company Research Administration, Oncore, RedCap and InfoED).

Benefits

  • Medical: Multiple plan options
  • Dental: Multiple plan options
  • Additional Insurance: Disability, Life, reputed company
  • Retirement 401(a) Plan: Employer contributes 10%25 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 reputed company CU campuses
  • ECO Pass: Reduced reputed company RTD Bus and light rail service
  • There are many additional perks & programs with the CU Advantage.

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