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University of Colorado Regulatory Affairs Coordinator (Open Rank) in Aurora, Colorado

Description

University of Colorado | CU Anschutz Medical Campus

School of Medicine, The Cancer Center

Research Services Professional (Entry, Intermediate, or Senior – Open Rank)

Regulatory Affairs Coordinator (Level I, II, or III – Open Rank)

Position #706009 – Requisition #19874

* 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 Cancer Center has an opening for a full-time University Staff (unclassified) Regulatory Affairs Coordinator 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. at https://www.cuanschutz.edu/docs/librariesprovider15/default-document-library/2019-facts-brochure_web.pdf

The University of Colorado (CU) Cancer Center headquartered at the Anschutz Medical Campus and part of the CU School of Medicine. It is Colorado’s only National Cancer Institute-designated comprehensive cancer center at http://www.cancer.gov/researchandfunding/extramural/cancercenters , a distinction recognizing its outstanding contributions to research, clinical trials, prevention and cancer control. CU Cancer Center’s clinical care sites are UCHealth, University of Colorado Hospital and Children’s Hospital Colorado are ranked nationally by U.S. News and World Report.

The CU Cancer Center is a member of the prestigious National Comprehensive Cancer Network® at http://www.nccn.org/ , an alliance of the nation’s leading cancer centers working to establish and deliver the gold standard in cancer clinical guidelines. CU Cancer Center also is a member of the Oncology Research Information Exchange Network (ORIEN) at http://www.oriencancer.org/ , a unique research partnership among North America’s top cancer centers leveraging multiple data sources and matching patients to targeted treatments. CU Cancer Center includes six institutional partners made up of approximately 300 researchers and physicians at three state universities and three healthcare delivery institutions.

The CU Cancer Center’s vision is to “prevent and conquer cancer. Together .” We do this through our mission statement of “uniting our community to overcome cancer through innovation, discovery, prevention, early detection, multidisciplinary care and education.”

Nature of Work

As an important member of the Cancer Clinical Trials Office (CCTO) Regulatory Affairs team, this position works with Phase I-IV industry sponsored (Pharmaceutical), Cooperative Group (NCTN) and/ or Investigator initiated clinical trials in accordance with FDA Regulations, Good Clinical Practice (GCP) and applicable guidelines or policies. The successful candidate will be responsible for providing regulatory management and oversight for clinical trials. Specific duties may include writing accurate informed consent forms, submissions to applicable review committees (PRMS, IRB of record, UCHealth Research Administration), completion of Regulatory documents (Form 1572, Financial Disclosure forms), protocol amendment submissions and semi-annual or annual IRB continuing reviews.

This position is also responsible for knowledge of Unanticipated Problem reporting in order to guide clinical colleagues in their submission requirements. In order to succeed in this position, this detail-oriented individual must be able to demonstrate superior organizational skills in order to successfully track multiple tasks occurring in parallel. This incumbent must be self-motivated in order to complete tasks quickly and within set deadlines. This position is 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.

Professional Field: Regulatory Affairs

Supervision Received: Regulatory Affairs Supervisor

Supervision Exercised: None

Examples of Work Performed for All Levels

  • Serves as regulatory contact person for ongoing clinical research studies and meets with representatives from sponsoring pharmaceutical firms or in-house staff for initial orientation to studies and for review of regulatory records.

  • Writes clear and accurate consent/ HIPAA documents.

  • Completes consents, applications and other required forms as per the applicable Institutional Review Board (IRB).

  • Submits, tracks and processes protocol amendments for National Clinical Trials Network (NCTN) studies within the required 90 day period.

  • Submits complete and accurate clinical research applications to all required regulatory bodies for the conduct of clinical research at the University of Colorado Cancer Center. 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)

  • Completes and submits continuing reviews, amendments, and other protocol-specific documents.

  • Completes and submits accurate federal forms, consents, HIPAA Authorizations, and obtains required approvals specific to the Denver VA medical Center.

  • Navigates applicable NCTN websites. This may include Clinical Trials Support Unit (CTSU), Southwest Oncology Group (SWOG) and NRG Oncology (NSABP, RTOG, GOG).

  • Updates OnCore with regulatory documents and dates.

Additional Duties for RAC 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 in document collection and site regulatory communication for multi-center clinical trials.

Additional Duties for RAC III

  • Potentially meets with representatives from Food and Drug Administration (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.

  • Collects documents and site regulatory communication for multi-center clinical trials

Additional Skills for RAC II

  • Understanding of research standards as set forth by FDA, OHRP, UCH, UCD and NCI.

Salary and Benefits:

The salary range (or hiring range) for this position has been established at $43,830.

The salary of the finalist(s) selected for this role will be set based on a variety of factors, including but not limited to, internal equity, experience, education, specialty and training.

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 at https://www.cu.edu/employee-services/benefits-wellness

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 hr.adacoordinator@ucdenver.edu.

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 Requirements for RAC I

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

  • Work Experience: One or more years of professional medical, clinical and/or research experience.

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

Preferred Qualifications for RAC I

  • At least 1 year of Regulatory experience.

  • Experience working with NCI, Industry, and Investigator Initiated clinical trials

  • Experience working in an academic and/or medical environment

Minimum Requirements for RAC II

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

  • Work Experience: Two or more years of professional research experience (One year must be oncology and/or academic regulatory experience)

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

Additional Preferred Qualifications for RAC II

  • Experience with submissions to the FDA for IND or IDE.

Minimum Requirements for RAC III

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

  • Work Experience: Three or more years of professional regulatory experience. At least two years of regulatory experience in oncology or a complex academic setting is required.

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

  • Certification Required for RAC III: Condition of Employment – Clinical Research Certification (i.e.,Certified Clinical Research Coordinator (CRC), Certified Clinical Research Professional (CCRP), Certified Clinical Research Associate (CCRA). Maintenance of this Certification requires at least 15 Continuing Education Units (CEUs) per year.

Additional Preferred Qualifications for RAC III

  • Working knowledge of FDA Regulations and OHRP Guidance – how they apply to oncology clinical trials

Required: Applicants must meet minimum qualifications at the time of hire.

PLEASE NOTE: Candidates will be responsible for travel expenses related to the interview process and any relocation expenses, if applicable.

Knowledge, Skills, and Abilities for all Levels

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

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

  • 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 comp

Job: Research Services

Primary Location: Aurora

Job Category Research Services

Department U0001 -- DENVER & ANSCHUTZ MED CAMPUS

Schedule Full-time

Posting Date Jan 11, 2021

Unposting Date Ongoing

Posting Contact Name Sherri Wilke

Posting Contact Email sherri.wilke@cuanschutz.edu

Posting Number 00706009

Req ID: 19874

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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