Denver Health and Hospital Authority (DHHA's) Research Compliance Manager (RCM) is responsible for implementing and directing a high quality, robust and visible research compliance program for the organization. The position includes responsibility for investigation and resolution of research compliance issues, maintenance of research compliance policies and procedures, providing regulatory guidance and advice on research compliance matters, conducting or coordinating focused training and education on research compliance, and participating in the Research Compliance Committee and the Quality Improvement Review Committee (QuIRC). The RCM will monitor various DHHA departmental operations as they relate to research compliance risk areas. The RCM will report to the DHHA Director of Enterprise Compliance Services and have a dotted line reporting relationship to the Chief Research Officer (CRO) and Director of Sponsored Projects and Research Office (SPARO).
Knowledge, Skills & Abilities
Education 1. Bachelor's degree required. 2. Advanced degree (e.g. Juris Doctor, Masters, PhD) preferred. Experience 1. Four years of experience working in a research or research compliance environment required. 2. Three years of experience working in one or more of the major compliance areas (human subjects' protection, care and use of animals, biosafety, radiation safety, or export control) required. 3. Experience in developing and conducting training programs related to compliance preferred. 4. Experience in a health care setting preferred. Knowledge, Skills and Abilities 1. Knowledge of Medicare Clinical Trial Policy (NCD 310.1) 2. Knowledge Regulations overseeing Clinical Trials including - 21 CFR: parts 50, 312, and 812, 45 CFR Part 46, ICH GCP E6(R1) 3. Knowledge of and experience in working with federal and state research compliance laws, regulations and sub regulatory guidance. 4. Strong commitment to research compliance and ethical compass. 5. Commitment and ability to: a. Work in a team-based environment, b. Handle patient and highly reputable researcher interactions/communication with extreme care, patience and consideration, and c. Create an environment with open channels of communication within the Organization with workforce members, patients and others. 6. Possess excellent organization, attention to detail, technical and analytical skills. Can gather relevant information systematically, break down problems into simple components and can make sound decisions. Approach problems with curiosity and open-mindedness and offer new ideas, solutions and/or options. Demonstrate discretion, diplomacy, and good judgment. 7. Initiate, develop, and maintain relationships and networks with peer research compliance officers, research compliance groups and committees (e.g., Partners HealthCare System and Alliance of Dedicated Cancer Center Research Compliance Officers and related groups). 8. Project management and change management skills; ensuring projects come to fruition from inception to completion. Certificates, Licenses and Registration Certified in Healthcare Research Compliance (CHRC) or Certified in Healthcare Compliance (CHC) preferred.
Location Administrative Offices Shift
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, efficient, high-quality academic health care system that is considered a model for the nation. The Denver Health system includes the Rocky Mountain Regional Level I Trauma Center, a 525-bed acute care medical center, Denver's 911 emergency medical response system, 8 family health centers, 15 school-based health centers, the Rocky Mountain Poison and Drug Center, the Denver Public Health Department, an HMO, and The Denver Health Foundation.
As Colorado's primary safety net institution, Denver Health is a mission-driven organization that has provided more than $3.3 billion in care for the uninsured in the last ten years. Denver Health is a leader in performance and quality improvements and remains financially secure, in part, due to its nationally recognized implementation of lean principles in healthcare. Denver Health is a major resource to the community, serving approximately 185,000 individuals and 67,000 children a year.
Located just south of 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 is committed to provide equal treatment and equal employment opportunities to all applicants and employees. Denver Health is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class."
Internal Number: 495
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.