Clinical Trials Project Manager

Job Summary:

The Clinical Research Project Manager is responsible for overseeing the protocol opening process to ensure shortest possible timelines are met for 1 to 3 different disease sites at a given time. Communicating as needed to the Sr. Project Manager of any problems in protocol opening.

Examples of Work Performed

Study Preparation (15%)

• Serves as primary contact person for clinical research studies in start-up and meets with representatives from sponsoring pharmaceutical firms or in-house staff for initial orientation to studies and for review of regulatory records. This may include the Food and Drug Administration (FDA).
• Works with regulatory specialist on study submission to PRMS and Research Administration Portal during start-up (this may include amendments prior to Site Initiation Visits).
• Manages routing of confidentially agreements (CDA) with the Clinical Research Administrations Office (CRAO).
• Plans and directs pre-study qualification visits with Sponsor and/or Contract Research Organization.
• Adds new trials to disease site schemas
• Adds new trials to VIA oncology platform

Study Project Management (70%)

• Manages routing and reviews of contract trial agreements (CTA) with the Clinical Research Administrations Office (CRAO).
• Completes OnCore specification and protocol sign-off during start-up.
• Acts as an interdepartmental liaison with UCH clinic staff (incl. investigators, nurses, clinic support staff, laboratory, pharmacy, radiology).
• Performs pre-reviews of all regulatory documents prior to IRB submission to promote quality study flow and ensure that all governing regulations are being adhered to.
• Takes responsibility for meeting internal and external timelines.
• CCTO Cancer Center Policies and Procedures in relation to conducting multiple clinical research trials and GCP.
• Manages all staff updates in OnCore in a timely and accurate manner for 1 to 3 disease sites during study start-up.
• Oversees OnCore calendar reviews and Medicare Analysis Reviews for 1-to 3 disease sites during start-up of a trial.
• Works with budget and regulatory specialist on amendment portal submissions for UCHealth during start-up.
• Submits and manages initial treatment plans through the UCHealth Beacon process and works with assigned RN for completion for 1 to 3 disease sites.
• Manages Internal Protocol Amendment Review forms or delegates responsibility as appropriate for 1 to 3 disease sites during start-up.
• Reviews budget and collaborates with budget specialist as needed during start-up.
• Helps facilitate the escalation plan with Contract Research Organizations and Sponsors as needed to keep the project moving.
• Updates OnCore fields, staff console, and internal trackers in a timely manner.
• Assists investigators with miscellaneous tasks as applicable for start-up.
• Attends clinical team meetings and SIV visits as necessary.

Administrative/Other (15%)

• Serves as role model to all Cancer Clinical Trial Office staff - remains in compliance with all training requirements, meets established deadlines, possesses a strong understanding of clinical research history, regulations, and ethics.
• Participates in cost savings/productivity strategies to meet or improve the trial budgets.
• Attends and participates in leadership and management courses for growth and skill development.
• Collaborates with Data Safety Monitoring Committee, Protocol Review Monitoring Committee, and Oncology Clinical Research Support Team on initiatives.
• Works with the Oncology Clinical Research Support Team staff on Investigator Initiated Trials reviewing protocol, IIT sign-off, and clinical toolkit.
• Provides guidance regarding FDA and Good Clinical Practice regulation to clinical and investigator staff.

Work Location:

Remote - this role is eligible to work remotely, but the employee must be in the United States.

Why Join Us:

The University of Colorado Cancer Center stands at the forefront of cancer research and patient care in Colorado. As the state's only National Cancer Institute (NCI) designated Comprehensive Cancer Center, we hold a prestigious distinction that acknowledges our exceptional contributions to the fields of research, clinical trials, prevention, and cancer control. Our guiding vision is clear: "prevent and conquer cancer. Together." At the heart of our mission is the work to "unite our community to overcome cancer through innovation, discovery, prevention, early detection, multidisciplinary care, and education.

Our more than 300 members, made up of renowned physicians and researchers, conduct patient-centered research to develop innovative, state-of-the-art technologies, and treatments. Crucial to this work is the nearly 300 staff members who help expand the reach of the CU Cancer Center. Our expertise across cancer types helps us provide world-class treatment for common cancers, while offering hope for many patients with difficult or aggressive cancers who have struggled to find treatment options elsewhere.

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.

To see what benefits are available, please visit: https://www.cu.edu/employee-services/benefits-wellness

Diversity and Equity:

At the University of Colorado Cancer Center (CU Cancer Center), we deem diversity in thought, perspective, lived experiences, and backgrounds to be essential for understanding and providing world-class health and cancer care to our diverse patient populations. We are, therefore, committed to the intentional development of a diverse, equitable, inclusive, and respectful academic community and workplace. We actively encourage individuals of all races, religions, national origins, genders, gender expressions, sexual orientations, ages, as well as veterans and individuals with disabilities to apply for positions at the CU Cancer Center.

If you are an applicant with a disability, the University will provide reasonable accommodations throughout the employment application process. Please contact the Human Resources ADA Coordinator at hr.adacoordinator@cuanschutz.edu to request an accommodation in accordance with the Americans with Disability Act.

Qualifications:

Minimum Requirements

• 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. Closely related experience in a medical, clinical, research or clinical research environment may substitute for the degree on a year-for-year basis.
• A minimum of 4 years' clinical research experience

Preferred Qualifications:

• Minimum of 2 years' Oncology experience (clinical or research)
• Minimum of 5 years' clinical, research or clinical research experience
• Experience working with Cancer Therapy Evaluation Program and PI initiated studies
• Experience working in an academic medical setting
• Experience in teaching, precepting and mentoring employees to clinical research
• Additional Certification (one of the following):
  
  
  
  • 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 multi-task.
• Understands the phases and concepts of clinical trials and the overall philosophies of conducting cooperative group research as they differ with NCI sponsored, private industry and investigator initiated clinical trials.
• Knowledge of research study budgets
• Understanding of computer systems (specifically MS Office Suite) and ability to work efficiently within various applications. Examples of work include creating treatment care plans for submission, utilizing workload management tools, and implementation or use of CTMS programs.
• 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, and NCI common toxicity definitions.
• Knowledge of basic human anatomy, physiology, and medical/pharmaceutical terminology
• Demonstrates the quick ability to learn, interpret and master complex protocol information.
• Knowledge of basic human anatomy, physiology, and medical/pharmaceutical terminology

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: alexandra.lynn@cuanschutz.edu

Screening of Applications Begins:

Applications will be accepted until finalists are identified, but preference will be given to complete applications received by November 18, 2024. 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

$67,403-78,861

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.