Prisma Health

Regulatory Coordinator, Research

Prisma Health

Greenville, SC, USA
Full-TimeDepends on ExperienceSenior LevelMasters
Job Description

Are you passionate about ensuring compliance in medical research? Do you thrive in a fast-paced, dynamic environment? Prisma Health is seeking a highly motivated Regulatory Coordinator to join our team. As a leading healthcare organization, we are dedicated to improving the lives of our patients through innovative research initiatives. In this role, you will play a crucial role in ensuring that all research studies are conducted ethically and in accordance with regulatory requirements. If you have a keen attention to detail, strong communication skills, and a desire to make a positive impact in the medical field, we want to hear from you!

  1. Oversee and manage the regulatory compliance of all medical research studies conducted at Prisma Health.
  2. Ensure that all research studies are conducted ethically and in accordance with regulatory requirements, including but not limited to FDA regulations and Institutional Review Board (IRB) guidelines.
  3. Develop and maintain a thorough understanding of current regulations and guidelines related to medical research.
  4. Serve as a liaison between the research team, IRB, and other regulatory bodies to ensure timely and accurate submission of all required documents and reports.
  5. Facilitate the preparation and submission of research protocols, informed consent forms, and other necessary documents to regulatory bodies.
  6. Conduct regular audits to ensure compliance with regulatory requirements and identify areas for improvement.
  7. Collaborate with research teams to ensure that all research documents and records are accurate, complete, and up-to-date.
  8. Monitor and track progress of research studies to ensure timely completion of required regulatory activities.
  9. Communicate any changes in regulations or guidelines to research teams and provide guidance for implementation.
  10. Maintain accurate and organized records of all regulatory documents and correspondence.
  11. Train and educate research team members on regulatory requirements and best practices for compliance.
  12. Participate in continuous quality improvement efforts to enhance the regulatory compliance process.
  13. Stay updated on new and emerging regulations and guidelines related to medical research and incorporate them into the compliance process.
Where is this job?
This job is located at Greenville, SC, USA
Job Qualifications
  • Bachelor's Degree In A Related Field Such As Healthcare Administration, Public Health, Or Clinical Research.

  • Minimum Of 2-3 Years Experience In Regulatory Affairs Or Research Coordination, Preferably In A Healthcare Setting.

  • Knowledge Of Federal And State Regulations Governing Clinical Research, Including Fda Regulations And Good Clinical Practice (Gcp) Guidelines.

  • Experience With Electronic Data Capture Systems And Regulatory Document Management.

  • Strong Attention To Detail And Ability To Manage Multiple Projects And Deadlines Simultaneously.

Required Skills
  • Quality Assurance

  • Project Management

  • Data Analysis

  • Training Development

  • Compliance monitoring

  • Document Preparation

  • Protocol Review

  • Audit Preparation

  • Regulatory Guidance

  • Irb Submissions

  • Research Ethics

  • Investig

Soft Skills
  • Communication

  • Conflict Resolution

  • Emotional Intelligence

  • Leadership

  • Time management

  • creativity

  • flexibility

  • Teamwork

  • Adaptability

  • Problem-Solving

Compensation

According to JobzMall, the average salary range for a Regulatory Coordinator, Research in Greenville, SC, USA is $45,000-$65,000 per year. This can vary depending on factors such as experience, education, and the specific industry or company the individual is working in.

Additional Information
Prisma Health is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate based upon race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.
Required LanguagesEnglish
Job PostedSeptember 19th, 2024
Apply BeforeMay 22nd, 2025
This job posting is from a verified source.Β 
Reposted

Apply with Video Cover Letter Add a warm greeting to your application and stand out!

About Prisma Health

Prisma Health is the largest not-for-profit health organization in South Carolina, serving more than 1.2 million patients annually. 32,000 team members are dedicated to supporting the health and well-being of people.

Frequently asked questions

Get interviewed today!

JobzMall is the worldβ€˜ s largest video talent marketplace.Itβ€˜s ultrafast, fun, and human.

Get Started