Regulatory Affairs Coordinator (Level I or II)
- Employer
- University of Colorado Anschutz Medical Campus
- Location
- Denver, CO
View more
- Administrative Jobs
- Academic Affairs, International Programs
- Employment Type
- Full Time
- Institution Type
- Four-Year Institution
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Description
University of Colorado | CU Anschutz Medical CampusColorado Center for Personalized MedicineResearch Services Professional - Regulatory Affairs Coordinator (Level I or II)Position #00781209 – Requisition #20164 * Applications are accepted electronically ONLY at www.cu.edu/cu-careers *The University of Colorado Anschutz Medical Campus seeks individuals with demonstrated commitment to creating an inclusive learning and working environment. We value the ability to engage effectively with students, faculty and staff of diverse backgrounds.The University of Colorado | Anschutz Medical Campus is seeking applications for a Regulatory Affairs Coordinator (Level I or II). This is a full-time, University Staff (non-classified) position.The University of Colorado Anschutz Medical Campus is a public education, clinical and research facility serving 4,500 students, and a world-class medical destination at the forefront of life-changing science, medicine, and healthcare. CU Anschutz offers more than 42 highly rated degree programs through 6 schools and colleges, and receives over $500 million in research awards each year. We are the single largest health professions education provider in Colorado, awarding nearly 1,450 degrees annually. Powered by our award-winning faculty, renowned researchers and a reputation for academic excellence, the CU Anschutz Medical Campus drives innovation from the classroom to the laboratory to the delivery of unparalleled patient care. Read CU Anschutz Quick Facts here. The University of Colorado’s Colorado Center for Personalized Medicine (CCPM) is a multi-institutional collaboration that pulls together disciplines and institutions across the University of Colorado Anschutz Medical Campus. The CCPM aims to uncover advancements in genetics and genomics that can improve diagnoses and develop medical solutions that are tailored to individuals. The overarching mission is to link extensive patient data to ‘omics’ information (genomics, proteomics etc.) to promote development of optimal prognostic and diagnostic tools for the clinical setting. The academic home for faculty in the CCPM is the Division of Biomedical Informatics & Personalized Medicine (BIPM).Job Summary:As an important member of the Colorado Center for Personalized Medicine (CCPM) Regulatory Affairs team, the Regulatory Affairs Coordinator will work with investigators across the CCPM, BIPM and Anschutz Medical Campus to facilitate ground breaking research endeavors. The successful candidate will be responsible for providing ongoing regulatory management and oversight for investigator-led research studies. The position will assist CCPM leadership and faculty with planning, organizing, and managing the administrative activities related to the submission of research protocols and amendments. This will include ongoing regulatory compliance for the CCPM-BIPM Faculty.Specific duties may include:Colorado Multiple Institutional Review Board (COMIRB) Western Institutional Review Board (WIRB) NCI Central Institutional Review Board (CIRB) Protocol Review and Monitoring System (PRMS) Hospital Research Support Services (UCH-RSS) University of Colorado Hospital Clinical Trials Office (CTO) Relevant regulatory, compliance and privacy officers of the University of Colorado, UCHealth, Children’s Hospital Colorado, and other partners Examples of Work Performed – RAC II:
Qualifications
Minimum Qualifications - RAC I:
Job Category: Research Services
Primary Location: Aurora
Schedule: Full-time
Posting Date: Feb 10, 2021
Unposting Date: Ongoing
University of Colorado | CU Anschutz Medical CampusColorado Center for Personalized MedicineResearch Services Professional - Regulatory Affairs Coordinator (Level I or II)Position #00781209 – Requisition #20164 * Applications are accepted electronically ONLY at www.cu.edu/cu-careers *The University of Colorado Anschutz Medical Campus seeks individuals with demonstrated commitment to creating an inclusive learning and working environment. We value the ability to engage effectively with students, faculty and staff of diverse backgrounds.The University of Colorado | Anschutz Medical Campus is seeking applications for a Regulatory Affairs Coordinator (Level I or II). This is a full-time, University Staff (non-classified) position.The University of Colorado Anschutz Medical Campus is a public education, clinical and research facility serving 4,500 students, and a world-class medical destination at the forefront of life-changing science, medicine, and healthcare. CU Anschutz offers more than 42 highly rated degree programs through 6 schools and colleges, and receives over $500 million in research awards each year. We are the single largest health professions education provider in Colorado, awarding nearly 1,450 degrees annually. Powered by our award-winning faculty, renowned researchers and a reputation for academic excellence, the CU Anschutz Medical Campus drives innovation from the classroom to the laboratory to the delivery of unparalleled patient care. Read CU Anschutz Quick Facts here. The University of Colorado’s Colorado Center for Personalized Medicine (CCPM) is a multi-institutional collaboration that pulls together disciplines and institutions across the University of Colorado Anschutz Medical Campus. The CCPM aims to uncover advancements in genetics and genomics that can improve diagnoses and develop medical solutions that are tailored to individuals. The overarching mission is to link extensive patient data to ‘omics’ information (genomics, proteomics etc.) to promote development of optimal prognostic and diagnostic tools for the clinical setting. The academic home for faculty in the CCPM is the Division of Biomedical Informatics & Personalized Medicine (BIPM).Job Summary:As an important member of the Colorado Center for Personalized Medicine (CCPM) Regulatory Affairs team, the Regulatory Affairs Coordinator will work with investigators across the CCPM, BIPM and Anschutz Medical Campus to facilitate ground breaking research endeavors. The successful candidate will be responsible for providing ongoing regulatory management and oversight for investigator-led research studies. The position will assist CCPM leadership and faculty with planning, organizing, and managing the administrative activities related to the submission of research protocols and amendments. This will include ongoing regulatory compliance for the CCPM-BIPM Faculty.Specific duties may include:
- developing appropriate informed consent forms,
- filing submissions to applicable review committees (Protocol Review and Monitoring System (PRMS), Institutional Review Board (IRB) of record, UCHealth Research Administration),
- completing regulatory documents (Financial Disclosure forms),
- submitting protocol amendments and semi-annual/annual IRB continuing review documents.
- Serves as regulatory contact person for ongoing research studies and meets with representatives from sponsors or in-house staff for initial orientation to studies and for review of regulatory records.
- Oversees review of all regulatory documents prior to IRB submission in order to promote quality study flow and ensure that all governing regulations are adhered to.
- Drafts clear, concise, and accurate consent/ HIPAA documents.
- Ensures adherence to research standard operating procedures, ICH/GCP guidelines, US Food and Drug Administration (FDA), and OHRP regulations, and any other additional institutional, state, federal or local regulatory requirements or research standards.
- Submits complete and accurate research applications to all required regulatory bodies for the conduct of research at the University of Colorado. This may include, but is not limited to, the following:
- Completes and submits continuing reviews, amendments, and other protocol-specific documents.
- Completes and submits accurate consents, IRB documents, federal forms, HIPAA Authorizations, and obtains, where necessary, required approvals specific to the Denver VA medical Center.
- Updates OnCore with regulatory documents and dates, as needed.
- Assist faculty with ancillary research agreements/Material transfer agreement that need routing to the Clinical Research Office or the Office of Grants and Contracts.
- Works with appropriate University of Colorado and UCHealth personnel to maintain the necessary legal and regulatory compliant processes related to enrollment of participants and the collection and storage of data and specimens for the CCPM Biobank
Qualifications
Minimum Qualifications - RAC I:
- Bachelor’s Degree in Business Administration, Communication or a related field from an accredited college or university.One year of Regulatory Affairs experience and professional medical, clinical and/or research experience.
- Bachelor’s Degree in Business Administration, Communication or a related field from an accredited college or university.One year of professional medical, clinical and/or research experience. One additional year of Regulatory Affairs experience.
- Experience working with academic Institutional Review Boards or FDA.Experience working with NIH, Industry, and Investigator Initiated research studiesExperience working in an academic and/or medical environmentUnderstanding of research standards as set forth by FDA, OHRP, UCHealth, and University of Colorado.
Job Category: Research Services
Primary Location: Aurora
Schedule: Full-time
Posting Date: Feb 10, 2021
Unposting Date: Ongoing
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