Regulatory Affairs Coordinator *****Applicationsare accepted electronically ONLY at www.cu.edu/cu-careers.* ** ** University of Colorado Denver lAnschutz Medical Campus School of Medicine, University ofColorado Cancer Center Regulatory Affairs Coordinator(Research Services Professional) Position #680338 Requisition 14406 ** ** The University of Colorado CancerCenter has an opening for a full-time, University Staff (unclassified) RegulatoryAffairs Coordinator (Research Services Professional) position. The University of Colorado AnschutzMedical Campus ranks among the top institutions nationally in clinical care,education and research. Its 230-acre campus, designed to enhance collaborationand interprofessional education, hosts the College of Nursing; the Schools ofDental Medicine, Medicine, Pharmacy, and Public Health; the Graduate School; aHealth Sciences Library; and two hospitals. Strategically located contiguous tothe campus are a biosciences research park and the soon-to-be-completedVeterans Hospital. CU Anschutz offers two undergraduate degrees, 35 graduatedegrees, and five first- professional programs. More than 4,000 students learnalongside faculty members who also make meaningful medical discoveries andprovide expert clinical care through 1.5 million patient-visits annually. A hubfor research and innovation, CU Anschutz receives over $400 million in researchawards each year and has filed 1,300 patent applications and formed 53 newcompanies since 2002. ReadCU Anschutz Quick Facts here. Nature of Work: The University of Colorado Cancer Center, located atthe Anschutz Medical Campus, is Colorados only National Cancer Institute-designatedcomprehensive cancer center, a distinction recognizing its outstandingcontributions to research, clinical trials, prevention and cancer control. CU Cancer Centers clinical partner for adultcare, University of Colorado Hospital is ranked in the top 15 hospitalsnationwide by U.S. News and World Report and Childrens Hospital Colorado isranked 8th by the same organization in Pediatric Cancer Care. The CU CancerCenter is a member of the prestigious National Comprehensive Cancer Network®, analliance of the nations leading cancer centers working to establish anddeliver the gold standard in cancer clinical guidelines. CU Cancer Center also is a member of theOncology Research Information Exchange Network (ORIEN), a unique researchpartnership among North Americas top cancer centers leveraging multiple datasources and matching patients to targeted treatments. CU Cancer Center is a consortium ofapproximately 261 researchers and physicians at three state universities andthree clinical institutions, all working toward its vision to prevent and curecancer while being a global model for patient care delivery, interdisciplinaryresearch, and training. As an important member of the Cancer Clinical TrialsOffice (CCTO) Regulatory Affairs team, this position works with Phase I-IVindustry sponsored (Pharmaceutical), Cooperative Group (NCTN) and/ orInvestigator initiated clinical trials in accordance with FDA Regulations, GoodClinical Practice (GCP) and applicable guidelines or policies. The successful candidate will be responsiblefor providing regulatory management and oversight for clinical trials. Specific duties may include writing accurateinformed consent forms, submissions to applicable review committees (PRMS, IRBof record, UCHealth Research Support Services), completion of Regulatorydocuments (Form 1572, Financial Disclosure forms, one page CVs), protocolamendment submissions and semi-annual or annual IRB continuing reviews. This position is also responsible for knowledge ofUnanticipated Problem reporting in order to guide clinical colleagues in theirsubmission requirements. In order tosucceed in this position, this detail-oriented individual must be able todemonstrate superior organizational skills in order to successfully trackmultiple tasks occurring in parallel. This incumbent must be self-motivated in order to complete tasks quicklyand within set deadlines. This positionis the hub of communication between external (review committee coordinators,review committee members, study monitors) and internal (clinical study staff,investigators, clinical managers) contacts so superior communication skills(oral and written) are required. _Examples of Work Performed: _ * Servesas regulatory contact person for ongoing clinical research studies and meetswith representatives from sponsoring pharmaceutical firms or in-house staff forinitial orientation to studies and for review of regulatory records. * Writesclear and accurate consent/ HIPAA documents. * Completesconsents, applications and other required forms as per the applicableInstitutional Review Board (IRB). * Submits,tracks and processes protocol amendments for National Clinical Trials Network(NCTN) studies within the required 90 day period. * Submitscomplete and accurate clinical research applications to all required regulatorybodies for the conduct of clinical research at the University of ColoradoCancer Center. This may include, but isnot limited to, the following: * ColoradoMultiple Institutional Review Board (COMIRB) * WesternInstitutional Review Board (WIRB) * NCICentral Institutional Review Board (CIRB) * ProtocolReview and Monitoring System (PRMS) * HospitalResearch Support Services (UCH-RSS) * Universityof Colorado Hospital Clinical Trials Office (CTO) * Completesand submits continuing reviews, amendments, and other protocol-specificdocuments. * Completesand submits accurate federal forms, consents, HIPAA Authorizations, and obtainsrequired approvals specific to the Denver VA medical Center. * Navigatesapplicable NCTN websites. This mayinclude Clinical Trials Support Unit (CTSU), Southwest Oncology Group (SWOG)and NRG Oncology (NSABP, RTOG, GOG). * UpdatesOnCore with regulatory documents and dates. Salary and Benefits: Thehiring salary for this position begins at $43,266 and is commensurate withskills and experience. Your total compensation goes beyond thenumber on your paycheck. The University of Colorado provides generous leave,health plans and retirement contributions that add to your bottom line. Benefits: . Total Compensation Calculator: Minimum Qualifications: * BachelorsDegree in any field from an accredited college or university. * One ormore years of medical, clinical and/or research experience. Substitution: Work experience in a related field maysubstitute for the degree on a year for year basis, but not for the specificexperience. Preferred Qualifications: * Atleast 1 year of Regulatory experience. * Experienceworking with NCI, Industry, and Investigator Initiated clinical trials. * Experienceworking in an academic and/or medical environment. Competencies/Knowledge, Skills, andAbilities: * Abilityto problem solve and multi-task. * Abilityto work independently. * Basicunderstanding of research specific to Human Subject Research protection, GoodClinical Practice and IRB requirements. * Goodcommand of the English language, both written and verbal. * Proficientin Windows, MS Word, Excel, PowerPoint. * Excellentcustomer service skills. * Demonstratedcommitment and leadership ability to advance diversity and inclusion. Diversity and Equity: The University will provide reasonable accommodations to applicants withdisabilities throughout the employment application process. To request an accommodation pursuant to theAmericans with Disabilities Act, please contact the Office of Equity by emailat equity_ada@ucdenver.edu or by phone at (303) 315-2567. The University of Colorado Denver | Anschutz Medical Campus is committedto recruiting and supporting a diverse student body, faculty and administrativestaff. The university strives to promote a culture of inclusiveness, respect,communication and understanding. We encourage applications from women, ethnicminorities, persons with disabilities and all veterans. The University ofColorado is committed to diversity and equality in education and employment. The University of Colorado Denver | Anschutz Medical Campus is dedicatedto ensuring a safe and secure environment for our faculty, staff, students andvisitors. To assist in achieving that goal, we conduct backgroundinvestigations for all prospective employees. **Primary Location: **Aurora **Work Locations: ** **Job: **Research Services **Organization: **Regents of the University of Colorado **Schedule: **Full-time **Job Posting: **Aug 20, 2018