Regulatory Affairs Coordinator (Level I or II)

Job description

Description
University of Colorado | CU Anschutz Medical Campus

Colorado Center for Personalized Medicine

Research 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. 
The Regulatory Affairs Coordinator will maintain compliance with all internal and external policies and procedures that govern CCPM and Anschutz Medical Campus research efforts.  The position will also be responsible for knowledge of the Common Rule and HIPAA requirements and their application in an academic research setting in order to guide colleagues in their regulatory submissions.  To succeed in this position, the successful candidate must be detail-oriented and demonstrate superior organization skills to efficiently track multiple projects.  The Regulatory Affairs Coordinator must be self-motivated in order to complete tasks quickly and within set deadlines.  This position is the ‘hub’ of communication between external (study monitors, review committee coordinators, and review committee members) and internal (study staff, study managers, and investigators) contacts so exemplary communication skills (oral and written) are required.  A demonstrated ability to work effectively with a diverse population of faculty, staff, students, and research participants is essential.

Examples of Work Performed – RAC I:

  • 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:
  • 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:

    • 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
    Salary and Benefits:

    The salary range (or hiring range) for a RAC I position has been established at $47,697 - $60,670.

    The salary range (or hiring range) for a RAC II position has been established at $51,564 - $65,590.

    The above salary range (or hiring range) represents the University’s good faith and reasonable estimate of the range of possible compensation at the time of posting.

    This position is not eligible for overtime compensation.

    Your total compensation goes beyond the number on your paycheck. The University of Colorado provides generous leave, health plans and retirement contributions that add to your bottom line.

    Benefits: https://www.cu.edu/employee-services/benefits

    Total Compensation Calculator: http://www.cu.edu/node/153125

    Diversity and Equity:

    The University will provide reasonable accommodations to applicants with disabilities throughout the employment application process. To request an accommodation pursuant to the Americans with Disabilities Act, please contact the Human Resources ADA Coordinator at [email protected].

    The University of Colorado Denver | Anschutz Medical Campus is committed to recruiting and supporting a diverse student body, faculty and administrative staff. The university strives to promote a culture of inclusiveness, respect, communication and understanding. We encourage applications from women, ethnic minorities, persons with disabilities and all veterans. The University of Colorado is committed to diversity and equality in education and employment.

    The University of Colorado Denver | Anschutz Medical Campus is dedicated to ensuring a safe and secure environment for our faculty, staff, students and visitors. To assist in achieving that goal, we conduct background investigations for all prospective employees.



    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.
    Substitution: Additional experience in a related field may substitute for the bachelor’s degree on a year-for-year basis, but not for the specific years of experience.

    Minimum Qualifications - RAC II:

      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.
    Substitution: Additional experience in a related field may substitute for the bachelor’s degree on a year-for-year basis, but not for the specific years of experience.

    Preferred Qualifications:

      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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    Job No:
    Posted: 2/11/2021
    Application Due: 5/12/2021
    Work Type: Full Time
    Salary: