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University of Colorado Protocol Review & Monitoring Coordinator in Aurora, Colorado

Description

University of Colorado | CU Anschutz Medical Campus

School of Medicine, The Cancer Center

Protocol Review and Monitoring Coordinator

Research Services Intermediate Professional

Position #779821 – Requisition #19602

* 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) Protocol Review and Monitoring 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 at http://www.oriencancer.org/ (ORIEN), 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

This position is responsible for the collection, interpretation, and documentation of clinical research data to facilitate the protocol monitoring responsibilities of the Protocol Review and Monitoring System (PRMS) at UCCC. An approved PRMS is a requirement of all NCI-designated cancer centers and assures appropriate scientific merit review and monitoring of all clinical research protocols.

Professional Field

Research Compliance and Regulatory Administration

Examples of Work Performed

  • Abstracts and records all research data pertaining to the accurate monitoring of scientific progress and underrepresented populations enrolled on UCCC studies, to facilitate evaluation by PRMS leadership

  • Query data from available electronic platforms (i.e. TriNetX®, OnCore®) to evaluate the feasibility of conducting new studies submitted to PRMS

  • Act as liaison between PRMS and Study Teams

  • To ensure proper protocol decision documentation is collected and filed

  • To reconcile team records with PRMS records and communicate any discrepancies found

  • Coordinates and meets data deadlines

  • Updates clinical trial management system(s) and performs data Quality Assurance checks as appropriate

  • Create training process documents

  • Completes administrative tasks requested by Supervisor, as necessary

  • Coordinates and facilitates PRMS meetings and arranges conference room details and conference call information.

  • Serves as administrative PRMS representative to internal and external audiences regarding PRMS activities.

This description is a summary only and is describing the general level of work being performed, it is not intended to be all-inclusive. The duties of this position may change from time to time and/or based on business need. We reserve the right to add or delete duties and responsibilities at the discretion of the supervisor and/or hiring authority.

Salary and Benefits:

The salary range begins at $46,609.

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 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 Qualifications

  • Bachelor’s Degree focused in biological, medical science or business such as Nursing, Biology, Public Health, Business Administration or related fields of study.

  • One (1) year of medical, clinical and/ or research experience

Substitution: Professional level work experience may be substituted for the education requirement on a year for year basis.

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

Preferred Qualifications

  • Research experience (oncology is a plus)

  • Experience with OnCore and/ or TriNetX a plus

  • Experience working with NCI, Industry and Investigator-Initiated trials.

  • Experience working in an academic and/or medical environment.

Knowledge, Skills, Abilities

  • Ability to problem solve and multi-task

  • Well-organized and extremely detail oriented

  • Able to interpret and master complex research protocol information

  • Intermediate to Advanced Microsoft Office skills (MS Word, Excel, Outlook)

  • Ability to work independently, but remain consistent with the PRMS requirements established by the NCI and the interpretation of those requirements by the UCCC leadership

  • Excellent interpersonal and communication skills, both written and verbal; proficient typing skills

  • Ability to manage competing deadlines and re-shift focus as necessary; is open to new ideas and methods; is able to work independently and as part of a team

  • Ability to work with faculty across the campus and external partners

  • Is responsible for exercising discretion and personal accountability in a wide range of areas including day to day administrative functions.

  • Possesses knowledge of Good Clinical Practices Manual, FDA Rules and Regulations in relation to clinical trials, NIH guidelines, ICH guidelines and HIPAA regulations in relation to the conduct of clinical trials

Job: Research Services

Primary Location: Aurora

Job Category Research Services

Department U0001 -- DENVER & ANSCHUTZ MED CAMPUS

Schedule Full-time

Posting Date Nov 19, 2020

Unposting Date Ongoing

Posting Contact Name Deborah McCollister

Posting Contact Email Deborah.mccollister@cuanschutz.edu

Posting Number 00779821

Req ID: 19602

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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