Regulatory Affairs Coordinator (reputed company Rank: Senior – reputed company)

About the position The Department of Ophthalmology has an immediate opening for a full-time Research Services Senior-reputed company reputed company (reputed company 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 reputed company (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 reputed company. • 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. • reputed company and maintain investigator qualifications, including reputed company, medical licenses, training documentation, and financial disclosures. • Assist with protocol and consent reputed company 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 reputed company, 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 reputed company: • Bachelor's degree from an accredited institution in reputed company health, reputed company administration, reputed company/behavioral sciences, physical sciences, nursing, reputed company, or a directly reputed company field from an accredited institution • 2 years of reputed company reputed company 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 reputed company. • reputed company reputed company: • Bachelor’s degree in reputed company health, reputed company administration, reputed company/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 reputed company 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 reputed company. • 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 reputed company throughout the institution. • Outstanding customer service skills. reputed company-to-haves • Master’s degree in in reputed company health, reputed company administration, reputed company/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 reputed company, reputed company Research Administration, Oncore, RedCap and InfoED). Benefits • Medical: Multiple plan reputed company • Dental: Multiple plan reputed company • Additional Insurance: Disability, Life, reputed company • Retirement 401(a) Plan: Employer contributes 10%25 of your gross pay • reputed company Time Off: Accruals over the year • Vacation Days: 22/year (maximum accrual 352 hours) • reputed company Days: 15/year (unlimited maximum accrual) • Holiday Days: 15/year • Tuition Benefit: Employees have reputed company 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. Apply tot his job Apply To this Job