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Being the heartbeat of Denver means our heart reflects something bigger than ourselves, something that connects us all:

Humanity in action, Triumph in hardship, Transformation in health.

Department

• Develop, implement, and maintain centralized clinical trial SOPs (5%)
• Provide training of investigators and clinical trials staff in the development, conduct and analysis of clinical trials (5%)
• Ensure that trials are conducted in accordance with federal, state and institutional regulations, including billing compliance (5%)
• Facilitate all FDA regulatory audits (5%)
• Assist PIs with Investigational New Drug (IND) and Investigational Device Exemption (IDE) applications when applicable (5%)
• Provide an essential layer of oversight and training for an increasingly large and complex clinical trials operation (15%)
• Oversee clinical trial portfolio management in conjunction with leadership to reflect the research goals, patient resource management and CTS resource allocation (10%)
• Supervise and train CTS staff to provide for the efficient and compliant conduct of clinical research trials (10%)
• Assisting leadership in aligning and developing CTS resources to match with DH research goals (5%)
• Conduct Medicare Cost Analysis Quality Assurance checks (5%)
• Directly supervise CTS staff (15%)
• Oversee the maintenance and any new implementations of a Clinical Trials Management System (CTMS) (5%)
• Oversee the maintenance and any new implementations of TriNetX (5%)
• Work closely with the Epic Research Analyst to develop and implement Epic Research advancements (5%)
• Other duties as assigned (0%)

• Bachelor's Degree Bachelor degree in related field or a combination of education and experience required. Required

• 4-6 years Six years of research administration experience, with at least 3 years of clinical trial experience preferred. Required

• Proficiency with MS Office Suite.
• Knowledge of financial mechanism that relates to clinical trials.
• Collecting and analyzing complex data.
• Ability to prioritize and perform a variety of duties independently.
• Project management.
• Knowledge of Medicare Clinical Trial Policy (NCD 310.1). Knowledge Regulations overseeing Clinical Trials including – 21 CFR: parts 50, 312, and 812, 45 CFR Part 46, ICH GCP E6(R1)
• CCRA, CCRC, CCRP, or equivalent credential required.

Shift

Work Type

Salary

Benefits

• Competitive pay

• Outstanding benefits

• Education opportunities

• Shared leadership and advancement opportunity

• State-of-the-art facilities

• Immediate retirement plan matching

• Professional clinical advancement program

• Participation in evidence-based projects

• Public Service Loan Forgiveness (PSLF) eligible employer

• National Health Service Corps (NHCS) and Colorado Health Service Corps (CHSC) eligible employer

Our Values

• Respect

• Belonging

• Accountability

• Transparency

All job applicants for safety-sensitive positions must pass a pre-employment drug test, once a conditional offer of employment has been made.

Denver Health is an integrated, high-quality academic health care system considered a model for the nation that includes a Level I Trauma Center, a 555-bed acute care medical center, Denver's 911 emergency medical response system, 10 family health centers, 19 school-based health centers, Rocky Mountain Poison & Drug Safety, a Public Health Institute, an HMO and The Denver Health Foundation.

As Colorado's primary, and essential, safety-net institution, Denver Health is a mission-driven organization that has provided billions in uncompensated care for the uninsured. Denver Health is viewed as an Anchor Institution for the community, focusing on hiring and purchasing locally as applicable, serving as a pillar for community needs, and caring for more than 185,000 individuals and 67,000 children a year.

Located near downtown Denver, Denver Health is just minutes away from many of the cultural and recreational activities Denver has to offer.

We strongly support diversity in the workforce and Denver Health is an equal opportunity employer (EOE).

Denver Health values the unique ideas, talents and contributions reflective of the needs of our community. For read more about our commitment to diversity visit: https://www.denverhealth.org/for-professionals/careers/diversity-and-inclusion

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About Denver Health

Take your career to the next level at Denver Health, where we offer a robust benefits package and endless opportunities for growth. Denver Health is a nationally-ranked, locally-trusted, premier healthcare institution located in the heart of Denver, Colorado.Twenty-five percent of all Denver residents, or approximately 150,000 individuals, receive their health care here. We are known as an integrated health care system that encompasses multidisciplinary academic specialties, a community health system, a level I adult trauma center, pediatric emergency and urgent care center home to Denver Public Health and many of the nation's leaders in medicine.Denver Health is an Equal Opportunity Employer At Denver Health we pride ourselves on our commitment to diversity. Equal opportunity is a fundamental principle of Denver Health. As an equal opportunity employer, Denver Health is committed to recruit, hire, promote and administer all human resource actions in a non-discriminatory manner. Denver Health is committed to providing equal opportunities in all business practices and to all persons regardless of age, race, color, national origin, genetic information, religion, sex, pregnancy, disab...ility, sexual orientation, gender identity, gender expression, marital status or veteran status (collectively “protected status”). Denver Health strives to maintain a work environment that is free from unlawful harassment and discrimination and will not tolerate any such conduct by employees or directed at employees within the scope of their employment. Read the full Human Resources Employee Principles and Practices policy.

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