Cancer Clinical Trials Office (CCTO) and Community Outreach and Engagement Professional - 31251 University Staff

Description
University of Colorado Anschutz Medical Campus

Department: Cancer Center

Job Title: Cancer Clinical Trials Office (CCTO) and Community Outreach and Engagement Professional

Position #674193: – Requisition #:31251

Job Summary:

This position is responsible for leading and providing communication between the Community Outreach and Engagement Office (COE) and the Cancer Clinical Trials Office (CCTO). One of the key responsibilities is to direct communication and collaboration between the CCTO Regulatory Compliance and Quality Program Manager, the CCTO Senior Regulatory Manager, CCTO Clinical team, and members of the COE team to ensure efficiencies and regulatory compliance within the underrepresented minorities (URM) program.

Key Responsibilities:

40% Collaboration and Communication Facilitation between COE Office and CCTO:

• Facilitate communication and collaboration between the COE Office team/COE Navigator and CCTO leadership team to help streamline the process of underrepresented minorities (URM) patient referrals and URM participation in CCTO clinical trials.
• Work across departments to develop and maintain a successful workflow to increase enrollment and clinical trial participation and retention for URMs.
• Represent CCTO at COE team meetings to increase cohesiveness between COE departmental initiatives and CCTO operations.
• Represent CCTO on CU Cancer Center Diversity Equity and Inclusion (DEI) Committee.
• Participate in URM Task Force meetings to propose and follow through on agenda items and initiatives from the CCTO and the CU Cancer Center DEI Committee.
• Coordinate subgroup initiatives with DEI Committee members, CCTO Regulatory Manager(s), CCTO Clinical Research Managers and CCTO Supervisor(s) to develop, implement and maintain CCTO guidance documents for processes that involve URM research subjects.

40% Compliance and Education

• Subject Matter Expert in FDA Regulations and GCP (Good Clinical Practice) guidelines to lead the development and implementation of standard practices for URMs.
• Subject Matter Expert in consenting processes for non-English speaking research subjects and keeping up to date on the requirements set forth by different IRBs including COMIRB, WCG IRB, CIRB, and others as applicable.
• Coordinate initial and ongoing training of Clinical staff on the consenting of non-English speaking subjects.
• Provide input on CU Cancer Center SOPs that include URMs.
• Provide input on CCTO Guidance Documents that include URMs

20% Data Collection and Tracking

• Facilitate the tracking of patients coming from outside community hospital clinics who participate in oncology clinical trials. This includes gathering data on retention and helping evaluate any barriers to participation that are identified by COE Patient Navigator, and/or CCTO Staff.
• Develop and maintain a database to track URM research subject information and participation in CCTO studies.

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 needs. We reserve the right to add or delete duties and responsibilities at the discretion of the supervisor and/or hiring authority.

Work Location:

Hybrid – This role is eligible for a hybrid schedule, working primarily remote and on campus as-needed for in-person meetings.

Why Join Us:

The University of Colorado Cancer Center is Colorado's only National Cancer Institute (NCI) designated Comprehensive Cancer Center, a distinction recognizing its outstanding contributions to research, clinical trials, prevention, and cancer control. 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." Our more than 300 renowned physicians and researchers conduct patient-centered research to develop innovative, state-of-the-art technologies, and treatments. Our expertise across cancer types helps us provide world-class treatment for common cancers, while offering hope for many patients with difficult or aggressive tumors who have struggled to find treatment options elsewhere.

The University of Colorado offers a comprehensive benefits package that includes health insurance, life insurance, retirement plans, tuition benefits, ECO pass, paid time off – vacation, sick, and holidays and more. To see what benefits are available, please visit: https://www.cu.edu/employee-services/benefits-wellness.

Diversity and Equity:

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, persons within the LGBTQ+ community and all veterans. The University of Colorado is committed to diversity and equality in education and employment.

Qualifications:

Minimum Qualifications:

• Bachelor's degree with a preferred emphasis in business, health administration, communications, biological or social science, or any other field of study related to the work assignment.
  • Substitution: Closely related experience in a medical, clinical, research, or clinical research environment may substitute for the degree on a year-for-year basis.
• Three (3) years of clinical research experience in a clinical research setting.

Preferred Qualifications:

• Experience with URM population programs
• Oncology regulatory and/ or clinical experience
• Experience writing standard operating procedures and guidance documents.
• Experience leading small working groups.
• Experience working simultaneously with various departments.
• Experience working in an academic medical setting.
• Working knowledge of short form consenting process
• Experience in teaching, and mentoring peers in clinical research

Conditions of Employment:

Certification is required within 12 months of hire (one of the below):

• CCRC – Certified Clinical Research Coordinator
• CCRP – Certified Clinical Research Professional
• CCRA – Certified Clinical Research Associate

Knowledge, Skills, and Abilities

• Excellent interpersonal communication, organizational skills, and ability to problem solve and manage multiple priorities and deadlines.
• Ability to work independently.
• Ability to establish and maintain effective working relationships with employees at all levels throughout the institution.
• Outstanding customer service skills
• Demonstrated commitment and leadership ability to advance diversity and inclusion.
• Demonstrates a quick ability to learn and adapt in a dynamic research environment.
• Knowledge of Federal Regulations and Good Clinical Practice(GCP) guidelines for consenting and enrolling non-English speaking human subjects in research trials.
• Knowledge of IRB requirements for consenting of non-English speaking subjects (COMIRB, CIRB, WCG IRB, and others as applicable).
• Understands the phases and concepts of clinical trials and the overall philosophies of conducting National Clinical Trials Network (NCTN) research as they differ from NCI sponsored, private industry and investigator-initiated clinical trials.
• Understanding of computer systems (specifically MS Office Suite, Adobe and Advarra OnCore) and ability to work efficiently within various applications. Examples of work include working within SIP and Advarra OnCore to perform regulatory tasks and/or develop guidelines for use of computer systems.
• Knowledge of Good Clinical Practices, FDA Regulations in relation to clinical trials, NIH guidelines, ICH guidelines, and HIPAA regulations in relation to clinical trials.

Applicants must meet minimum qualifications at the time of application.

How to Apply:

For full consideration, please submit the following document(s):

1. A letter of interest describing relevant job experiences as they relate to listed job qualifications and interest in the position.
2. Curriculum vitae / Resume
3. Three to five professional references, including name, address, phone number (mobile number if appropriate), and email address.

Questions should be directed to: jill.lee@cuanschutz.edu

Screening of Applications Begins:

Applications will be accepted until finalists are identified, but preference will be given to complete applications received by September 30, 2023. Those who do not apply by this date may or may not be considered.

Anticipated Pay Range:

The beginning of the salary range for this position is $65,812. The actual salary will be determined by the candidate's qualifications.

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 may be eligible for overtime compensation, depending on the level.

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.

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

ADA Statement:

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@cuanschutz.edu​.

Background Check Statement:

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.

Vaccination Statement:

CU Anschutz strongly encourages vaccination against the COVID-19 virus and other vaccine preventable diseases. If you work, visit, or volunteer in healthcare facilities or clinics operated by our affiliated hospital or clinical partners or by CU Anschutz, you will be required to comply with the vaccination and medical surveillance policies of the facilities or clinics where you work, visit, or volunteer, respectively. In addition, if you work in certain research areas or perform certain safety sensitive job duties, you must enroll in the occupational health medical surveillance program.
Application Materials Required: Cover Letter, Resume/CV, List of References

Job Category: Research Services

Primary Location: Aurora Department: U0001 -- DENVER & ANSCHUTZ MED CAMPUS - 20066 - SOM-U of Colo Cancer Center

Schedule: Full-time

Posting Date: Sep 20, 2023

Unposting Date: Ongoing Posting Contact Name: Jill Lee Posting Contact Email: jill.lee@cuanschutz.edu Position Number: 00674193





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