NCTN Clinical Research Coordinator (Open Rank)

Job Summary:

As a member of the Cancer Clinical Trials Office (CCTO) Regulatory Affairs team, this position provides professional support to Phase I-IV industry sponsored (Pharmaceutical), National Group (NCTN, ETCTN) and/or Investigator initiated clinical trials ensuring compliance with FDA regulations, Good Clinical Practice (GCP) and applicable guidelines or policies. With the increasing complexity of oncology cancer treatments, clinical trial design, as well as regulations (internal and external) this role manage the regulatory aspects of clinical trials, ensuring study-specific goals and timelines are met, coordinating regulatory documents, and submitting them to the appropriate review committees.

Clinical Trial Compliance, Monitoring & Auditing - 40%

• Develops knowledge of Good Clinical Practices, FDA Rules and Regulations in relation to clinical trials, NIH guidelines, ICH guidelines, and HIPAA regulations in relation to clinical trials.
• Assures adherence to all research standards set forth by the Food and Drug Administration (FDA), Office of Human Research Protection (OHRP), UCHealth, NCI and other pertinent regulatory agencies.
• Completes the preparation, review, and completion of Regulatory documents to ensure accuracy, and compliance with applicable regulations and site policies.
• Oversee the training of current and new investigators and staff on obtaining regulatory document signatures using DocuSign to ensure compliance with institutional requirements and 21 CFR Part 11 regulation.
• Collaborates with Regulatory Affairs Specialists during audit preparation, managing access to regulatory documents and study eBinders for auditors, and efficiently fulfilling document requests during FDA inspections. May manage the audit process for own studies.
• Coordinates Regulatory monitoring visits for assigned workload.
  
  
  
  • Oversees the Electronic compilation of lab verifications, CVs, and licenses
  • Schedules and confirms Regulatory monitoring visits
  • Manages sponsor monitor access to regulatory binders (paper and electronic versions)
  • Meets with monitors and auditors to respond to questions regarding regulatory documents and regulatory binders (paper and electronic versions)
  
  
  
  

Clinical Trial Documentation, System & Study Oversight - 60%

• Maintains low risk studies in long-term follow-up or industry studies nearing IRB closure.
  
  
  
  • Complete personnel and protocol amendments
  • Compile enrollment information to complete Continuing Review (CRV) submissions
  • Complete and submit IRB study closure submissions
  
  
  
  
• Completes personnel management tasks in Advarra eReg, including collaborating with Regulatory staff in developing and optimizing processes to accommodate future system enhancements, ensure compliance, and improve workflow efficiency.
• Completes new investigator documentation:
  
  
  
  • Determine and verify mailing address for new investigators to ensure accurate inclusion of investigator details on ICFs and 1572s.
  • Ensures new investigator COI disclosures are completed and assist new investigators as needed through this process as needed.
  • Maintains the Drs By Disease site spreadsheet as investigators are onboarded or depart our institution.
  
  
  
  
• Updates OnCore with regulatory documents and dates including but not limited to IRB closures, Continuing review information.
• Maintains OnCore Staff tab for all assigned studies.
• Coordinates all Regulatory study archiving activities to ensure records are retained in compliance with Good Clinical Practice (GCP) through detailed planning, preparation and post-archival maintenance.
• Assists in NCTN trial activities related to CTSU/lead site communications and new site investigators.
• Review CTSU broadcasts and disseminate relevant information to appropriate Regulatory Affairs Specialist to ensure compliance with NCI amendment guidelines.
• Gather and compile necessary information to complete CIRB PI worksheets for new investigators. Review, revise, and update CIRB PI worksheets for existing investigators to ensure compliance with current institutional policies. Updates may be conducted individually or on a broader scale when a global update is required.
• Stay up to date with CIRB and local institutional policies, procedures, and requirements to ensure PI worksheet compliance.
• Assists with monitoring CTEP ID status for new investigators.

Work Location:

Hybrid - This is not a remote position. This offer is contingent upon you working full-time, hybrid, on the Anschutz Medical Campus. You may be eligible to work a hybrid schedule after six months of employment. This benefit must be approved by your supervisor. In the event of departmental workload increase or special projects, you may be asked to report full-time on site until project completion.

Why Join Us:

Why work for the University?

We have AMAZING benefits and offer exceptional amounts of holiday, vacation and sick leave! The University of Colorado offers an excellent benefits package including:

• Medical: Multiple plan options
• Dental: Multiple plan options
• Additional Insurance: Disability, Life, Vision
• Retirement 401(a) Plan: Employer contributes 10% of your gross pay
• Paid Time Off: Accruals over the year
• Vacation Days: 22/year (maximum accrual 352 hours)
• Sick Days: 15/year (unlimited maximum accrual)
• Holiday Days: 10/year
• Tuition Benefit: Employees have access to this benefit on all CU campuses
• ECO Pass: Reduced rate RTD Bus and light rail service

There are many additional perks & programs with the CU Advantage.

Qualifications:

Minimum Qualifications:

• 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 year for year basis
  
  
  
  
• Required for RCC: Condition of Employment -
  
  
  
  • Individual must obtain and track continuing education regardless of whether they have an additional certification (required annual levels):
    
    
    
    • RCC- 5 CEUs per calendar year
    
    
    
    
  
  
  
  

Preferred Qualifications:

• 1 year of professional medical, clinical and/or research experience.
• Experience with human subject/clinical research regulations
• Experience working in an academic and/or medical environment.
• Experience with Clinical Trial Management System, Advarra eReg, Docusign, OneDrive

Competencies/Knowledge, Skills, and Abilities:

• 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.
• Ability to manage multiple priorities and deadlines.
• Ability to work as part of a team.
• Excellent computer skills (proficient in Microsoft Office Suite, Adobe, Excel).
• Knowledge of IRB reporting and submission requirements for amendments, personnel changes, and IRB study closures.

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 (only use if a cover letter is necessary)
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: Kimberly Hogan, kimberly.hogan@cuanschutz.edu

Screening of Applications Begins:

Applications will be accepted until finalists are identified, but preference will be given to complete applications received by April 18, 2025. Those who do not apply by this date may or may not be considered.

Anticipated Pay Range:

The starting salary range (or hiring range) for this position has been established as:

Entry: $48,446 - $61,623

Intermediate: $52,721 - $67,061

Senior: $56,995 - $72,498

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

Equal Employment Opportunity Statement:

The University of Colorado (CU) is an Equal Opportunity Employer and complies with all applicable federal, state, and local laws governing non-discrimination in employment. We are committed to creating a workplace where all individuals are treated with respect and dignity, and we encourage individuals from all backgrounds to apply.

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.