IRB Compliance Coordinator

This job posting is no longer active.

Description

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.

IRB Compliance Coordinator 

Do you have the career opportunities as an IRB Compliance Coordinator you want with your current employer? We have an exciting opportunity for you to join HealthOne which is part of the nation's leading provider of healthcare services, HCA Healthcare.

Benefits

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

Note: Eligibility for benefits may vary by location.

Our teams are a committed, caring group of colleagues. Do you want to work as a(an) Clinical Research Coordinator where your passion for creating positive patient interactions are valued? If you are dedicated to caring for the well-being of others, this could be your next opportunity. We want your knowledge and expertise!

Job Summary and Qualifications

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.

DUTIES INCLUDE BUT ARE NOT LIMITED TO:

• · Conduct preliminary administrative reviews on protocol study applications. Independently collaborate with investigators to ensure that all regulatory and institutional policies are adhered to within the study submission requirements.
• · 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.
• · Generate correspondence and technical reports for investigators, sponsors, IRB board members, and other facility personnel on research protocol and compliance issues.
• · Ability to utilize IRB electronic protocol submission program.
• · Maintain software system for management of IRB protocol submissions.
• · Negotiate administrative modifications to existing IRB applications with research staff personnel. 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.
• · 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. Provide assistance with the development of written office procedures and training materials.
• · Assist with routine and for-cause audits for research studies approved through the HCA-HealthONE IRB.
• · Practice and adhere to the “Code of Conduct” philosophy and “Mission and Value Statement.”
• · Other duties as assigned.

What qualifications you will need:

EDUCATION

· Bachelor’s degree in medical or research field preferred.

EXPERIENCE

· Research and regulatory experience preferred.

CERTIFICATE/LICENSE 

 Certified IRB Professional (CIP) certification preferred, but not required.

This role requires you to be fully vaccinated for COVID-19 based on local, state and /or federal law or regulations (unless a medical or religious exemption is approved).

As part of HCA Healthcare, we at HealthONE® 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.

"Bricks and mortar do not make a hospital. People do."- Dr. Thomas Frist, Sr.
HCA Healthcare Co-Founder

If you are looking for an opportunity that provides satisfaction and personal growth, we encourage you to apply for our Clinical Research Coordinator opening. We promptly review all applications. Highly qualified candidates will be contacted for interviews. Unlock the possibilities and 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.

Apply