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Stellan Henderson
IRB Compliance Coordinator
Summary
Highly motivated and experienced IRB Compliance Coordinator with a proven track record of ensuring compliance with ethical guidelines and regulatory requirements in the research domain. Possesses a deep understanding of IRB protocols, federal guidelines, and institutional policies. Demonstrated expertise in developing and implementing effective IRB policies and procedures, providing guidance and training to researchers, and conducting audits and inspections to assess IRB compliance. Proficient in utilizing software systems and online platforms to streamline the IRB review and approval process. Committed to promoting IRB awareness and enhancing ethical research practices.
Education
Master of Science in Clinical Research
January 2017
Skills
- IRB Protocol Review
- Compliance Management
- Regulatory Knowledge
- Investigator Education and Training
- Data Protection
- Risk Assessment
Work Experience
IRB Compliance Coordinator
- Conducted audits and inspections to assess IRB compliance and identify areas for improvement.
- Collaborated with researchers, administrators, and legal counsel to address complex ethical and regulatory issues.
- Utilized software systems and online platforms to streamline the IRB review and approval process.
- Developed educational materials and presentations to promote IRB awareness and enhance compliance.
IRB Compliance Coordinator
- Facilitated IRB submission and approval of over 100 research protocols annually, ensuring compliance with ethical guidelines and regulatory requirements.
- Developed and implemented IRB policies and procedures to streamline the review process and enhance efficiency.
- Provided guidance and training to researchers on IRBrelated regulations, including federal guidelines (e.g., Common Rule, HIPAA) and institutional policies.
- Managed and maintained IRB records and documentation, including protocol applications, consent forms, and adverse event reports.
Accomplishments
- Developed and implemented a standardized IRB review process, reducing review time by 40%
- Successfully navigated complex regulatory requirements, ensuring compliance for all IRBapproved research
- Established a robust IRB training program, empowering researchers with essential compliance knowledge
- Led the implementation of an electronic IRB system, streamlining submission and review processes
- Collaborated with researchers and sponsors to develop innovative compliance solutions
Awards
- Recognized for Outstanding Contribution to IRB Compliance
- Awarded the Ethics Committee Excellence Award for innovative IRB practices
- Named top IRB Compliance Coordinator in the industry by the Compliance Review Board
- Received the National Institutes of Health (NIH) Grant for promoting ethical research practices
Certificates
- Certified IRB Professional (CIP)
- Credentialed IRB Professional (CIP)
- Associate Certified Professional in Regulatory Affairs (ACPRA)
- Certified Clinical Research Associate (CCRA)
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How To Write Resume For IRB Compliance Coordinator
- Highlight your understanding of IRB protocols, federal regulations, and ethical guidelines in your resume.
- Quantify your accomplishments whenever possible. For example, instead of saying ‘Facilitated IRB submission and approval of research protocols,’ you could say ‘Facilitated IRB submission and approval of over 100 research protocols annually, ensuring compliance with ethical guidelines and regulatory requirements.’
- Use keywords throughout your resume that potential employers will be searching for, such as ‘IRB Compliance’, ‘Regulatory Knowledge’, and ‘Investigator Education’.
- Proofread your resume carefully before submitting it. Make sure there are no errors in grammar or spelling.
Essential Experience Highlights for a Strong IRB Compliance Coordinator Resume
- Review and assess IRB protocols to ensure compliance with ethical and regulatory guidelines.
- Develop and implement IRB policies and procedures to streamline the review process and enhance efficiency.
- Provide guidance and training to researchers on IRB-related regulations and ethical considerations.
- Manage and maintain IRB records, including protocol applications, consent forms, and adverse event reports.
- Conduct audits and inspections to assess IRB compliance and identify areas for improvement.
- Collaborate with researchers, administrators, and legal counsel to address complex ethical and regulatory issues.
- Utilize software systems and online platforms to streamline the IRB review and approval process.
Frequently Asked Questions (FAQ’s) For IRB Compliance Coordinator
What is the role of an IRB Compliance Coordinator?
An IRB Compliance Coordinator is responsible for ensuring that research protocols comply with ethical guidelines and regulatory requirements. They review and assess protocols, develop and implement IRB policies and procedures, provide guidance and training to researchers, and conduct audits and inspections to assess IRB compliance.
What are the qualifications for an IRB Compliance Coordinator?
A Master’s degree in Clinical Research or a related field is typically required for an IRB Compliance Coordinator position. Additionally, certification in IRB compliance is often preferred.
What are the key skills for an IRB Compliance Coordinator?
Key skills for an IRB Compliance Coordinator include knowledge of IRB protocols, federal regulations, and ethical guidelines, as well as experience in developing and implementing IRB policies and procedures. Additionally, strong communication and interpersonal skills are essential.
What is the job outlook for IRB Compliance Coordinators?
The job outlook for IRB Compliance Coordinators is expected to grow in the coming years. As the number of research protocols increases, so too will the need for qualified IRB Compliance Coordinators to ensure that these protocols comply with ethical guidelines and regulatory requirements.
What are the benefits of working as an IRB Compliance Coordinator?
Benefits of working as an IRB Compliance Coordinator include the opportunity to make a positive impact on the research community, the chance to learn about a variety of research topics, and the opportunity to work with a team of dedicated professionals.
What are the challenges of working as an IRB Compliance Coordinator?
Challenges of working as an IRB Compliance Coordinator include the need to stay up-to-date on ethical guidelines and regulatory requirements, the need to work with a variety of stakeholders, and the need to make difficult decisions about whether or not to approve research protocols.
What is the salary range for IRB Compliance Coordinators?
The salary range for IRB Compliance Coordinators varies depending on experience and location. However, the median salary for IRB Compliance Coordinators is around \$75,000 per year.
What are the career advancement opportunities for IRB Compliance Coordinators?
Career advancement opportunities for IRB Compliance Coordinators include the opportunity to become an IRB Manager, an IRB Director, or a Vice President of Research Compliance.