Senior Regulatory Affairs Specialist - CRO in Nashville, Tennessee, United States
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Sarah Cannon Network

Senior Regulatory Affairs Specialist - CRO

New
Nashville, TN, United States
Full-time • Days 7-10 Hrs/Wkdays Only
Quality Risk and Safety   Job ID: 61701
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Description

Introduction

As a Senior Regulatory Affairs Specialist, are you passionate about the patient experience? Our Sarah Cannon and HCA Healthcare colleagues are committed to caring for patients with purpose and integrity.  

Benefits

We are committed to providing our employees with the support they need by offering eligible colleagues an attractive benefit package that includes medical, wellbeing, dental and vision benefits along with other unique benefits including:

  • Medical, Dental, Vision, Life Insurance and Flexible Spending
  • Paid Time Off (PTO) and Personal Leave
  • 401K (100% annual match - 3% to 9% of pay based on years of service)
  • Academic Assistance and Reimbursements for Tuition and Student Loans
  • Employee Discounts including Tickets, Retail, Mental Health Apps, Education Apps, Identity Theft Protection etc.
  • HomeAuto, and Pet Insurance
  • Employee Stock Purchase Program (ESPP)
  • Short Term Long Term Disability coverage
  • Adoption Assistance
  • Legal Benefits and lots more!

Learn more about Employee Benefits

By joining our team as a Senior Regulatory Affairs Specialist, you'll find that we care for our community! Just last year, our Sarah Cannon and HCA Healthcare colleagues donated $13.8 million dollars to charitable organizations. 

Job Summary 

Our Senior Regulatory Affairs Specialist is responsible and accountable for coordinating the activities of physicians and the clinical team with respect to creating and maintaining required essential regulatory documents. This position ensures compliance with regulatory requirements. This position will work closely with the regulatory affairs management, department director and/or primary investigators to ensure compliance, improve regulatory processes, and handle multiple tasks while meeting strict deadlines. The Senior Regulatory Affairs Specialist (SRAS) will have mastered the responsibilities of the Regulatory Affairs Specialist and require little to no supervision. The Senior RAS will carry an expanded study workload. 

Duties include and are not limited to

  • You maintain our FDA and GCP required regulatory documentation for individual sites, studies, sponsors and/or other networks. Ensures all regulatory documentation is compliant with local Standard Operating Procedures (SOP’s) for format and content.
  • You will ensure that essential regulatory documents are created and maintained for all assigned studies. You will ensure that these regulatory documents are completed in a timely way to meet department and sponsor timelines.
  • You maintain updated physician credentials.
  • You modify and/or develop informed consent forms and manages protocol and consent form modifications or amendments in compliance with IRB policy and HIPAA.
  • You organize and coordinate IRB documentation for trials.
  • You will communicate with sponsors, investigators, CROs, internal leadership, and other partners to inform and to resolve problems.
  • You are our primary liaison with monitors from CRO partners and sponsors to provide documentation, resolve issues and ensure compliance.
  • You will assist internal and external audit team with regulatory related issues.
  • You will apprise management of all study and site-specific regulatory issues for guidance and follow through.
  • You archive study specific regulatory documentation and correspondence.


Qualifications needed

  • Minimum High School Diploma/GED obtained - Bachelor’s Degree or equivalent combination of education and experience may be substituted
  • Minimum 3 years’ work experience in the Regulatory Affairs Specialist role
  • Strong knowledge of scientific and clinical research terminology
  • Knowledge of IRB, FDA, and GCP guidelines
  • SOCRA Certification and/or ACRP Certification highly preferred


Sarah Cannon is the Cancer Institute of HCA Healthcare. We offer integrated cancer services with easy access to cutting-edge therapies for communities across the United States and United Kingdom. Sarah Cannon’s cancer programs include individualized patient navigation. Our nurses are oncology-trained. More than 1,200 stem cell transplants are performed yearly within the Sarah Cannon Blood Cancer Network. Through its services, Sarah Cannon provides state-of-the-art cancer care for hundreds of thousands of patients. Our cancer experts are collaborating and sharing best practices. We address every aspect of the cancer journey, from screening and diagnosis through treatment and survivorship.

HCA Healthcare has been named one of the World's Most Ethical Companies by Ethisphere Institute for over a decade.  In recent years, HCA Healthcare spent an estimated $3.7 billion in cost for the delivery 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 Affairs Specialist 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.

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Details

Quality Risk and Safety
Full-time • Days 7-10 Hrs/Wkdays Only

About HCA Healthcare

What matters most to our diverse and talented colleagues is giving people the absolute best healthcare in the most compassionate way possible.

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