**Description** Salary Estimate: $54891.20 - $82388.80 / year Learn more about the benefits offered ( https://careers.hcahealthcare.com/pages/employee-benefits-and-rewards ) for this job. The estimate displayed represents the typical salary range of candidates hired. Factors that may be used to determine your actual salary may include your specific skills, how many years of experience you have and comparison to other employees already in this role. The typical candidate is hired below midpoint of the range. **Introduction** Are you looking for a work environment where diversity and inclusion thrive? Submit your application for our IRB (Institutional Review Board) Coordinator opening with HCA HealthOne today and find out what it truly means to be a part of the HCA Healthcare team. **Benefits** HCA HealthOne, offers a total rewards package that supports the health, life, career and retirement of our colleagues. The available plans and programs include: + Comprehensive medical coverage that covers many common services at no cost or for a low copay. Plans include prescription drug and behavioral health coverage as well as free telemedicine services and free AirMed medical transportation. + Additional options for dental and vision benefits, life and disability coverage, flexible spending accounts, supplemental health protection plans (accident, critical illness, hospital indemnity), auto and home insurance, identity theft protection, legal counseling, long-term care coverage, moving assistance, pet insurance and more. + Free counseling services and resources for emotional, physical and financial wellbeing + 401(k) Plan with a 100% match on 3% to 9% of pay (based on years of service) + Employee Stock Purchase Plan with 10% off HCA Healthcare stock + Family support through fertility and family building benefits with Progyny and adoption assistance. + Referral services for child, elder and pet care, home and auto repair, event planning and more + Consumer discounts through Abenity and Consumer Discounts + Retirement readiness, rollover assistance services and preferred banking partnerships + Education assistance (tuition, student loan, certification support, dependent scholarships) + Colleague recognition program + Time Away From Work Program (paid time off, paid family leave, long- and short-term disability coverage and leaves of absence) + Employee Health Assistance Fund that offers free employee-only coverage to full-time and part-time colleagues based on income. Learn more about Employee Benefits (https://careers.hcahealthcare.com/pages/employee-benefits-and-rewards) **_Note: Eligibility for benefits may vary by location._** We are seeking a(an) IRB Coordinator for our team to ensure that we continue to provide all patients with high quality, efficient care. Did you get into our industry for these reasons? We are an amazing team that works hard to support each other and are seeking a phenomenal addition like you who feels patient care is as meaningful as we do. We want you to apply! **Job Summary and Qualifications** **You will be responsible for completing high level work for the management of research protocols for IRB review. Collaborate with personnel to support the implementation of the research compliance program for researchers, sponsors, IRB members and the HCA-HealthONE facilities. Conduct administrative reviews on clinical research protocol submissions. Implement procedures to ensure regulatory compliance with the Health and Human Services (HHS) departments, the Food and Drug Administration (FDA) and the Office of Human Research Protections (OHRP), and to provide regulatory guidance.** **What you will do in this role:** + **You will conduct preliminary administrative reviews on protocol study applications. You will independently collaborate with investigators to ensure that all regulatory and institutional policies are adhered to within the study submission requirements.** + **You will collaborate with the research staff personnel to ensure clinical research compliance is maintained and adequately documented for new protocol submissions, amendment revisions, protocol renewals and closures, adverse events, and protocol deviations.** + **You will generate correspondence and technical reports for investigators, sponsors, IRB board members, and other facility personnel on research protocol and compliance issues.** + **You will have the ability to utilize IRB electronic protocol submission program.** + **You will maintain software system for management of IRB protocol submissions.** + **You will negotiate administrative modifications to existing IRB applications with research staff personnel. You will provide information on technical and ethical requirements for conducting clinical research and provide assistance to researchers to bring proposals into compliance with the federal and institutional policies.** + **You will assist in the development and implementation of training and education programs for investigators and other research staff personnel in interpreting the federal regulations as related to clinical research. You will provide assistance with the development of written office procedures and training materials.** + **You will assist with routine and for-cause audits for research studies approved through the HCA-HealthONE IRB.** **What qualifications you will need:** + Bachelor’s degree in medical or research field preferred. + Research and regulatory experience preferred. + Certified IRB Professional (CIP) certification preferred, but not required. **Knowledge and Skills:** + Possess excellent writing skills for composing technical reports and correspondence. + Knowledge of compliance and regulatory components of the informed consent, protocols, and submission process. + Research process: Knowledge of compliance and regulatory components of the informed consent, protocols, and submission process. + Knowledge of the clinical research process at the research site to assist with compliance review audits. + Ability to research, comprehend, and interpret the Code of Federal Regulations. Working knowledge of the Belmont Report, the Declaration of Helsinki, and the Nuremberg Code. + Understanding of the operation of the Food and Drug Administration (FDA) and the Federal Office of Human Research Protections (OHRP). + High level of discretion when working with sponsors, investigators, and other contacts, due to the confidential information and documents managed within the department. + Good critical thinking skills. Decision making and strong organizational skills are essential. + Strong customer service skills. Ability to utilize problem-solving techniques. + Proficient in Microsoft Office applications (Word, Excel, Outlook, Power Point), Internet searches, and relevant data bases. + Ability to work independently and under pressure to follow through on issues. + Ability to communicate clearly and concisely, both verbally and in writing. + Ability to establish and maintain long-term customer relationships, building trust and respect by consistently meeting and exceeding expectations. + Ability to work effectively with other employees and external parties. As part of HCA Healthcare, we at HealthONE® (https://healthonecares.com/) serve the **metro Denver area as the largest healthcare system, with more than 11,000 employees** . Our hospitals – **The Medical Center of Aurora, North Suburban Medical Center, Presbyterian/St. Luke’s Medical Center, Rocky Mountain Hospital for Children, Rose Medical Center, Sky Ridge Medical Center, Swedish Medical Center and Spalding Rehabilitation Hospital** work together to provide a higher level of care. In addition, our system includes eight hospital freestanding emergency departments and numerous ambulatory surgery centers, eight CareNow urgent care centers and occupational medicine clinics, physician practices, medical imaging centers and AirLife Denver, which provides critical care air and ground transportation serving Colorado and surrounding states. "There is so much good to do in the world and so many different ways to do it."- Dr. Thomas Frist, Sr. HCA Healthcare Co-Founder If you find this opportunity compelling, we encourage you to apply for our Clinical Coordinator Research opening. We promptly review all applications. Highly qualified candidates will be directly contacted by a member of our team. **We are interviewing apply today!** We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.