Introduction

Are you passionate about the patient experience? At HCA Healthcare, we are committed to caring for patients with purpose and integrity. We care like family! Jump-start your career as our Senior Regulatory Strategy Operations Manager today with Sarah Cannon Network.

Benefits

Sarah Cannon Network 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 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.
• Fertility and family building benefits through Progyny
  
• Free counseling services and resources for emotional, physical and financial wellbeing
  
• Family support, including adoption assistance, child and elder care resources and consumer discounts
  
• 401(k) Plan with a 100% match on 3% to 9% of pay (based on years of service)
  
• Employee Stock Purchase Plan
  
• Retirement readiness and rollover 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)

Learn more about Employee Benefits

Note: Eligibility for benefits may vary by location.

Come join our team as our Senior Regulatory Strategy Operations Manager. We care for our community! Just last year, HCA Healthcare and our colleagues donated $13.8 million dollars to charitable organizations. Apply Today!

Job Summary and Qualifications

You will be responsible for the orderly and efficient coordination of the regulatory responsibilities for Sarah Cannon as Sponsor of clinical trials. You will ensure that all Sponsor regulatory requirements are conducted and maintained in accordance with current FDA regulations, GCP guidelines, and internal SOP’s.

Duties include but are not limited to:

• Oversee through initiation and maintenance, the Sponsor regulatory processes and serves as primary point of contact for Sponsor-related regulatory activities
• Ensure maintenance of and as necessary the creation and submission of required FDA, IRB and GCP regulatory documentation for Sarah Cannon Sponsored clinical trials including but not limited to IND annual and update reporting, IRB routine and ad hoc reports
• Ensure all regulatory documentation is compliant with Sponsor Standard Operating Procedures (SOPs) for format and content
• Create and prepare routine reports of Sponsor regulatory affairs and trial related updates as needed
• Serve as a liaison between Sponsor affairs and site/ trial operations to maintain regulatory oversight
• Review and organize applicable regulatory documentation in preparation for and completion of FDA, IRB, Pharmaceutical Funding Partner (PFP), and internal QA audits as applicable

Qualifications needed

• Associate Degree required, Bachelor Degree highly preferred
• 2+ years’ experience with Regulatory Affairs within clinical research
• 2+ years’ experience in management of IND or IDE submissions.
• RAC, CCRP, or ACRP highly preferred

Sarah Cannon is the Cancer Instituteof HCA Healthcare. We offerintegrated cancer services with easy access to cutting-edge therapies for communitiesacross the United States and United Kingdom. Sarah Cannon’s cancer programs include individualized patient navigation. Ournurses are oncology-trained. Morethan 1,200 stem cell transplants are performed yearly within the Sarah Cannon Blood Cancer Network.Through its services, Sarah Cannonprovides state-of-the-art cancer care for hundreds of thousands of patients. Ourcancer experts are collaborating and sharing best practices. We address every aspect of the cancer journey, from screening anddiagnosis through treatment and survivorship.

HCA Healthcare has been recognized as one of the World’s Most Ethical Companies® by the Ethisphere Institute more than ten times. In recent years, HCA Healthcare spent an estimated $3.7 billion in cost for thedelivery of charitable care, uninsured discounts, and other uncompensated expenses.

"The great hospitals will always put the patient and the patient's family first, and the really great institutions will provide care with warmth, compassion, and dignity for the individual."- 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 Senior Regulatory Strategy Operations Manager 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.