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University of Colorado Research Services Professional in Aurora, Colorado

Description

* Applications are accepted electronically ONLY at www.cu.edu/cu-careers

  • University of Colorado | Anschutz Medical Campus

School of Medicine/VCHA/CCPM

Regulatory Affairs Coordinator (Level I, II, or III)

Position #00772611 – Requisition #18381

The University of Colorado | Anschutz Medical Campus is a public research university serving more than 18,000 students. We award nearly 4,000 degrees each year, including more graduate and professional degrees than any other Colorado institution. With our solid academic reputation, award-winning faculty and renowned researchers, we offer more than 140 highly rated degree programs through 13 schools and colleges. The university receives over $400 million in research awards each year. In addition to the wide array of health-related programs and facilities offered at CU Anschutz in Aurora, Colo. a significant number of undergraduate and graduate degree programs are taught at CU Denver, our comprehensive campus in the heart of downtown Denver—one of America’s most vibrant urban centers. CU Denver is located steps from the Denver Center for Performing Arts and the LoDo District affording our students, faculty and staff access to a broad array of academic, professional, community, recreational and cultural outlets.

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.

The University of Colorado | Anschutz Medical Campus is seeking applications for a Regulatory Affairs Coordinator (Level I, II, or III). This is a full-time, University Staff (non-classified) position.

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 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 institution-wide CCPM Biobank clinical research study.

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.

Professional Field: Regulatory Affairs

Supervision Received: Regulatory and Compliance Manager

Supervision Exercised: None

Examples of Work Performed (All Levels):

  • Serves as regulatory contact person for ongoing clinical 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 clinical 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:

o Colorado Multiple Institutional Review Board (COMIRB)

o Western Institutional Review Board (WIRB)

o NCI Central Institutional Review Board (CIRB)

o Protocol Review and Monitoring System (PRMS)

o Hospital Research Support Services (UCH-RSS)

o University of Colorado Hospital Clinical Trials Office (CTO)

o Relevant regulatory, compliance and privacy officers of the University of Colorado, UCHealth, Children’s Hospital Colorado, and other partners

  • 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.

  • 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.

  • Assists researchers in the development of protocols that leverage both data and specimens from the CCPM Biobank.

Additional Duties for Regulatory Affairs Coordinator II:

  • Assists in the completion of initial Institutional Biosafety (IBC) applications.

  • Provides shadowing of daily tasks for new members of the Regulatory Affairs team.

  • Serves as back up coverage during RAC absences.

  • Assists researchers in developing internal and external collaborative research studies.

  • Drafts and edits grant proposal sections.

Additional Duties for Regulatory Affairs Coordinator III:

  • Provides education on relevant policies and procedures.

  • Develops and maintains standard operating procedures for research activities.

  • Potentially meets with representatives from the FDA for review of records.

  • Completes required documents for all submissions specific to trials requiring Institutional Biosafety Committee (IBC) oversight.

  • Completes required documents for all submissions specific to trials requiring FDA approval.

  • Assists with training for new members of the Regulatory Affairs team.

  • Serves as back up coverage during RAC absences.

  • Contribute to the development of regulatory and compliance procedures for new partners.

Salary and Benefits:

The hiring salary for this position is negotiable and commensurate with skills and experience. This position is not eligible for overtime compensation.

The University of Colorado offers a full benefits package. Information on University benefits programs, including eligibility, is located at https://www.cu.edu/employee-services at https://www.jobsatcu.com/hr/postings/true .

Diversity and Equity:

Please click here for information on disability accommodations: http://www.ucdenver.edu/about/departments/HR/jobs/Pages/JobsatCUDenver.aspx

The University of Colorado | 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 | 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 for Regulatory Affairs Coordinator I:

  • Bachelor’s Degree in any field from an accredited college or university

Substitution: Work experience in a related field may substitute for the degree on a year for year basis

Preferred Qualifications for Regulatory Affairs Coordinator I:

  • One year of professional medical, clinical and/or research experience

  • Experience working with NIH, Industry, and Investigator Initiated research studies

  • Experience working in an academic and/or medical environment

Minimum Qualifications for Regulatory Affairs Coordinator II:

  • Bachelor’s Degree in any field from an accredited college or university

  • One year of Regulatory Affairs experience

Substitution: Work experience in a related field may substitute for the degree on a year for year basis.

Preferred Qualifications for Regulatory Affairs Coordinator II:

  • Two or more years of professional medical, clinical and/or research experience.

  • Experience working with academic Institutional Review Boards or FDA.

Minimum Qualifications for Regulatory Affairs Coordinator III:

  • Bachelor’s Degree in any field from an accredited college or university

  • Two years of professional medical, clinical and/or research experience. At least two years of Regulatory Affairs experience is required.

Substitution: Work experience in a related field may substitute for the degree on a year for year basis.

Preferred Qualifications for Regulatory Affairs Coordinator III:

  • A relevant postgraduate qualification.

  • Regulatory Affairs Certification or Clinical Research Certification.

  • Three or more years of professional medical, clinical, and/or research experience in a complex academic setting.

Knowledge, Skills, and Abilities for all Levels:

  • Ability to communicate effectively, both orally and in writing.

  • Ability to establish and maintain effective working relationships with employees at all levels throughout the Anschutz Medical Campus.

  • Outstanding customer service skills.

  • Attention to detail

  • Committed to fostering an environment that is inclusive and diverse.

  • Ability to problem solve, and manage multiple priorities and deadlines.

  • Ability to work as part of a team

  • Excellent computer skills (proficient in Windows, MS Word, Excel, PowerPoint)

Additional Knowledge, Skills, and Abilities for Regulatory Affairs Coordinator II:

  • Understanding of research standards as set forth by FDA, OHRP, UCHealth, and University of Colorado.

Job: Research Services

Primary Location: Aurora

Job Category Research Services

Department U0001 -- DENVER & ANSCHUTZ MED CAMPUS

Schedule Full-time

Posting Date Feb 18, 2020

Unposting Date Ongoing

Posting Contact Name Sandra Logue

Posting Contact Email Sandra.logue@cuanschutz.edu

Posting Number 00772611

Req ID: 18381

The University of Colorado does not discriminate on the basis of race, color, national origin, sex, age, pregnancy, disability, creed, religion, sexual orientation, gender identity, gender expression, veteran status, political affiliation, or political philosophy. All qualified individuals are encouraged to apply.

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