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

Clinical Regulatory Affairs Specialist - CRO

New
Nashville, TN, United States
Full-time • Work From Home
Quality Risk and Safety   Job ID: 61705
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Description

Introduction

Are you passionate about the patient experience? At Sarah Cannon along with our HCA Healthcare colleagues, we are committed to caring for patients with purpose and integrity. Jump-start your career as a Clinical Regulatory Affairs Specialist with our Sarah Cannon Network and see what it means to care like family!

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

Come join our team as a Clinical Regulatory Affairs Specialist, and you'll see how we all care for our community! Just last year, Sarah Cannon along with our HCA Healthcare colleagues donated $13.8 million dollars to charitable organizations.

Job Summary 

Primary responsibilities include managing and planning regulatory affairs compliance for industry sponsors and/or sites in networks. This position will work closely with the regulatory affairs management, department director and/or primary investigators to ensure compliance, preparing for auditing activities while meeting strict deadlines. The Regulatory Affairs Specialist II will be a seasoned professional in the role and will require minimal supervision. The Regulatory Affairs Specialist II will maintain an expanded study workload compared to the Regulatory Affairs Specialist.

Duties include and are not limited to

  • Establishes and maintains a document management system for regulatory paper and electronic files
  • Maintains 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
  • Maintains critical documentation ensuring compliance
  • Modifies and/or develops informed consent forms and updates and manages protocol and consent form modifications or amendments in compliance with IRB policy and HIPAA
  • Organizes and coordinates IRB documentation for trials
  • Processing of Safety Notifications that meet the IRB reportable criteria
  • Assists any internal or external audit team with any regulatory related issues
  • Apprises Regulatory Affairs Manager and Network Management, if applicable, of all study and site-specific regulatory issues for guidance and follow through
  • Archives study specific regulatory documentation and correspondence
  • Attends network meetings, conference calls and monthly staff meetings as appropriate
  • Participates in educational activities and programs
  • Maintains strictest confidentiality

Qualifications needed

  • Associate Degree, or work experience in lieu of a Bachelor’s Degree (4-year program) required
  • 1 – 3 years’ work experience in healthcare, research, or other science related field
  • Knowledge of scientific and clinical research terminology is essential
  • Knowledge of IRB, FDA and GCP guidelines required
  • Two years in healthcare, research or other science related field
  • Safety experience in clinical research or other healthcare environment
  • Direct regulatory affairs experience 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 remote Clinical 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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Quality Risk and Safety
Full-time • Work From Home

About HCA Healthcare

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