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Regulatory Coordinator

Company: Sarah Cannon Network
Location: Nashville
Posted on: November 11, 2019

Job Description:

Description SHIFT: No Weekends

SCHEDULE: Full-time

Sarah Cannon--is theresearch arm of HCA---s global cancer enterprise. Focused on advancing therapiesfor patients, it is one of the world---s leading clinical research organizationsconducting community-based clinical trials in oncology, cardiology andorthopedics through affiliations with a network of more than 1,000 physiciansacross the United States and United Kingdom.--

We believe our success is dependent on a healthywork environment where staff members are the core of advancing therapies forpatients and accelerating drug development. We apply the same compassion andcommitment we have for our patients to our co-workers and colleagues andpromote an entrepreneurial culture.--
Benefits:
We offer you an excellent total compensation package, including competitive salary, excellent benefit package and growth opportunities. We believe in our team and your ability to do excellent work with us. Your benefits include 401k, PTO medical, dental, flex spending, life, disability, tuition reimbursement, employee discount program, employee stock purchase program and student loan repayment. We would love to talk to you about this fantastic opportunity.
--
Summary of Key Responsibilities:
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.

Duties and Responsibilities:
Duties include but are not limited to:

  • Processes regulatory document signature request through electronic signature platform--
  • Tracks documents pending site regulatory signatures--
  • Provide site level regulatory support to the Clinical Operations--- sites and internal department managers in relation to the status of start-up and ongoing regulatory maintenance--
  • 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 updated physician credentials for network participants and other critical documentation ensuring compliance--
  • Triages site requests for regulatory support and identifies correct pathway for issue resolution----Qualifications Competencies:
    • Knowledge:A body of information needed to perform tasks; May be obtained through education,training or experience
      • Medical and clinical research terminology
      • MS Office--
        • --Skills: The proficiency to perform a certain task--
          • Interpersonal and communication skills--
          • Organizational skills
            • Abilities:--An underlying, enduring trait useful for performing duties
              • Works within deadlines--
              • Requires interpersonal, communication, and organizational skills--
                Education:Minimum Required: Associates Degree (2 yr program)Preferred: Bachelor's College Degree (4 yr program)
                Experience:
                • Customer focused experience--
                • Direct related regulatory experience--
                  Do you want to be a part of a teamworking together to fight cancer?

                  We are excited to speak with youabout this phenomenal opportunity. Apply to hear more.--We are anequal opportunity employer and value diversity at our company. We do notdiscriminate on the basis of race, religion, color, national origin, gender,sexual orientation, age, marital status, veteran status, or disability status.

                  Notice Our Company---s recruiters are here to help unlock the next possibility within your career and we take your candidate experience very seriously. During the recruitment process, no recruiter or employee will request financial or personal information (Social Security Number, credit card or bank information, etc.) from you via email. The recruiters will not email you from a public webmail client like Gmail or Yahoo Mail. If you feel suspicious of a job posting or job-related email, contact us at--privacy@hcahealthcare.com

                  Company Description:

                  HCA Healthcare is a collaborative healthcare network, driven by physicians, nurses and colleagues helping each other champion the practice of medicine to give people a healthier tomorrow. With a comprehensive network of more than 270,000 people across approximately 1,800 care facilities, our scale enables us to deliver great outcomes for our patients, provide superior nursing care and be a preferred place for physicians to practice medicine. We never stop in our pursuit of insights and care advances based on the knowledge and data we gain from approximately 30 million patient encounters a year. Every day, we raise the bar to improve the way healthcare is delivered, not just in our facilities, but everywhere. We---re committed to improving more lives in more ways, and above all else, we are committed to the care and improvement of human life.

Keywords: Sarah Cannon Network, Nashville , Regulatory Coordinator, Other , Nashville, Tennessee

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