Principal Auditor - Clinical Research
Are you a seasoned auditor with a passion for promoting ethical and high-quality clinical research? Do you have experience leading audits and ensuring compliance in a fast-paced academic environment? Duke University is seeking a dynamic individual to join our team as the Principal Auditor for Clinical Research. In this role, you will play a crucial role in upholding our institution's commitment to excellence and integrity in all aspects of clinical research. We are looking for someone who is detail-oriented, collaborative, and driven to make a positive impact on the field of healthcare. If you are ready to take on a leadership role and contribute to groundbreaking research, we encourage you to apply.
- Conduct audits of clinical research studies to ensure compliance with institutional policies and federal regulations.
- Develop and maintain audit plans and schedules for ongoing and new studies.
- Lead and coordinate audit teams, including training and mentoring junior auditors.
- Review data and documents from clinical research studies to identify areas of non-compliance and make recommendations for corrective actions.
- Collaborate with research teams to implement corrective actions and ensure adherence to compliance standards.
- Stay up-to-date on regulatory changes and best practices in clinical research auditing.
- Develop and maintain relationships with external auditors and regulatory agencies.
- Provide guidance and support to researchers on ethical and regulatory requirements for clinical research.
- Prepare audit reports and present findings to senior management and stakeholders.
- Serve as a subject matter expert on clinical research compliance and provide training and education to research teams.
- Contribute to the development and improvement of institutional policies and procedures related to clinical research.
- Participate in quality improvement initiatives and contribute to the overall success and reputation of the institution's research program.
- Maintain strict confidentiality and integrity in all aspects of work.
- Represent the institution in a professional and ethical manner at all times.
- Embrace and promote a diverse and inclusive work environment.
Extensive Knowledge Of Clinical Research Regulations: A Principal Auditor At Duke University Should Possess A Deep Understanding Of Federal, State, And Local Regulations Governing Clinical Research, Such As Fda Regulations, Ich Guidelines, And Gcp Standards.
Strong Auditing Experience And Skills: The Ideal Candidate Should Have At Least 5 Years Of Experience In Conducting Audits Of Clinical Research Studies, Including Experience With Various Study Designs And Phases. They Should Also Possess Strong Analytical, Critical Thinking, And Problem-Solving Skills.
Excellent Communication And Interpersonal Skills: As A Principal Auditor, The Candidate Will Be Responsible For Communicating Audit Findings And Recommendations To Various Stakeholders, Including Researchers, Sponsors, And Regulatory Agencies. Therefore, Strong Written And Verbal Communication Skills And The Ability To Build Positive Working Relationships Are Essential.
Advanced Education And Certifications: A Master's Degree In A Relevant Field Such As Clinical Research, Public Health, Or Healthcare Administration Is Preferred For This Role. Additionally, Certifications Such As Certified Clinical Research Professional (Ccrp) Or Certified Clinical Research Associate (Ccra) Would Be Highly Desirable.
Attention To Detail And Ability To Work Independently: Auditing Clinical Research Studies Requires Meticulous Attention To Detail And The Ability To Work Independently. The Ideal Candidate Should Be Highly Organized And Able To Manage Multiple Projects Simultaneously, While Also Being Able To Work Autonomously And Make Sound Decisions.
Quality Assurance
Communication Skills
Project Management
Data Analysis
Report Writing
Team Leadership
Risk assessment
Investigative skills
Compliance monitoring
Audit planning
Regulatory Knowledge
Process
Communication
Conflict Resolution
Emotional Intelligence
Leadership
Time management
creativity
Teamwork
Adaptability
Problem-Solving
Decision-making
According to JobzMall, the average salary range for a Principal Auditor - Clinical Research in Durham, NC, USA is $123,000 - $143,000 per year. The actual salary may vary depending on the individual's experience, education, and specific job responsibilities. Other factors that can affect salary include the size and type of the organization, industry, and location.
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Duke University is a private research university in Durham, North Carolina. Founded by Methodists and Quakers in the present-day town of Trinity in 1838, the school moved to Durham in 1892. In 1924, tobacco and electric power industrialist James Buchanan Duke established The Duke Endowment and the institution changed its name to honor his deceased father, Washington Duke. Duke's campus spans over 8,600 acres (3,500 hectares) on three contiguous sub-campuses in Durham as well as a marine lab in Beaufort. The West Campus—designed largely by architect Julian Abele—incorporates Gothic architecture with the 210-foot (64-meter) Duke Chapel at the campus' center and highest point of elevation, is adjacent to the Medical Center. East Campus, 1.5 miles (2.4 kilometers) away, home to all first-years, contains Georgian-style architecture. The university administers two concurrent schools in Asia, Duke-NUS Medical School in Singapore (established in 2005) and Duke Kunshan University in Kunshan, China (established in 2013).
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