
Clinical Research Quality Specialist B
Are you passionate about improving healthcare and making a difference in the lives of patients? The University of Pennsylvania is seeking a highly motivated and detail-oriented individual to join our team as a Clinical Research Quality Specialist B. In this role, you will play a critical role in ensuring the quality and integrity of our clinical research studies. Our ideal candidate has a strong understanding of clinical research regulations and standards, excellent communication skills, and a keen eye for detail. If you are ready to take on a challenging and rewarding position in a prestigious academic institution, we encourage you to apply today!
- Oversee the quality and integrity of clinical research studies conducted at the University of Pennsylvania.
- Review and assess study protocols, data, and documentation to ensure compliance with applicable regulations and standards.
- Develop and implement quality assurance procedures and processes for clinical research studies.
- Conduct regular audits and inspections of study sites, data, and documentation to identify and address any discrepancies or issues.
- Work collaboratively with research teams to identify and resolve any quality-related issues in a timely manner.
- Train and educate research staff on quality control procedures and regulations.
- Stay up-to-date on relevant regulations and standards related to clinical research, and ensure compliance within the institution.
- Communicate any quality issues and findings to senior management in a clear and concise manner.
- Maintain accurate and detailed records of quality control activities and findings.
- Participate in the development and improvement of research processes and procedures to ensure ongoing quality improvement.
- Collaborate with external regulatory agencies and sponsors to facilitate inspections and address any findings.
- Serve as a resource and point of contact for all quality-related inquiries and provide guidance to research teams as needed.
- Uphold the ethical principles of clinical research and ensure the protection of human subjects.
- Continuously evaluate and improve the quality control program to meet the changing needs of the institution and industry.
- Contribute to the overall success of the clinical research program at the University of Pennsylvania by maintaining high standards of quality and compliance.
Bachelor's Degree In A Relevant Field Such As Biology, Chemistry, Or Healthcare Administration.
Minimum Of 2 Years Experience In Clinical Research, Preferably In A Quality Assurance Or Compliance Role.
Knowledge Of Fda Regulations And Guidelines Related To Clinical Research, Including Good Clinical Practice (Gcp) And International Conference On Harmonization (Ich) Guidelines.
Strong Attention To Detail And Ability To Identify Potential Issues Or Areas For Improvement In Research Processes.
Excellent Communication And Interpersonal Skills, With The Ability To Work Collaboratively With Interdisciplinary Teams And Effectively Train And Educate Others On Quality Standards And Best Practices.
Quality Assurance
Data Analysis
Team Leadership
Risk assessment
Document management
Regulatory reporting
Compliance monitoring
SOP Development
Protocol Review
G
Audit Preparation
Investigator Training
Communication
Conflict Resolution
Emotional Intelligence
Leadership
Time management
Interpersonal Skills
creativity
Teamwork
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a Clinical Research Quality Specialist B in 3400 Spruce St, Philadelphia, PA 19104, USA is $55,000-$85,000 per year. However, this can vary based on factors such as the specific company, years of experience, and education level. It is best to research the specific company and job posting for a more accurate salary range.
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The University of Pennsylvania, often abbreviated simply as Penn or UPenn, is a private Ivy League research university in Philadelphia. It was one of nine colonial colleges chartered prior to the U.S. Declaration of Independence when Benjamin Franklin, the university's founder and first president, advocated for an educational institution that trained leaders in academia, commerce, and public service. Penn identifies as the fourth-oldest institution of higher education in the United States, though this representation is challenged by other universities. Benjamin Franklin and other Philadelphians established the university in 1749, which would make it the fifth-oldest institution of higher education. The university has four undergraduate schools and 12 graduate and professional schools. Schools enrolling undergraduates include the College of Arts and Sciences, the School of Engineering and Applied Science, the Wharton School, and the School of Nursing. Among its highly ranked graduate schools are its law school, whose first professor James Wilson participated in writing the first draft of the U.S. Constitution, its medical school, the first in North America, and Wharton, the nation's first collegiate business school.

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