Clinical Research Regulatory Specialist B

Are you an experienced clinical research professional with a passion for ensuring ethical and compliant practices? Look no further! The University of Pennsylvania is seeking a highly-motivated and detail-oriented individual to join our team as a Clinical Research Regulatory Specialist B. In this role, you will play a critical role in ensuring the integrity and safety of our clinical research studies. We are looking for someone who is dedicated, organized, and has excellent communication skills. If you are ready to make a difference in the field of clinical research, apply now!

1. Ensure compliance with all ethical and regulatory guidelines for clinical research studies.
2. Develop and maintain a thorough understanding of all applicable regulations, policies, and procedures related to clinical research.
3. Serve as a liaison between the University and external regulatory agencies to ensure adherence to all regulatory requirements.
4. Develop and maintain relationships with research teams and assist in the development and implementation of research protocols.
5. Review and approve all study documents, including informed consent forms, study protocols, and other regulatory documents.
6. Conduct regular audits to ensure compliance with regulations and identify any potential areas of non-compliance.
7. Provide guidance and training to research staff on regulatory requirements and best practices.
8. Monitor and track progress of ongoing studies to ensure timely submission of required regulatory documents.
9. Communicate with study sponsors and other external stakeholders to ensure compliance with regulatory requirements.
10. Maintain accurate and up-to-date records of all regulatory submissions and approvals.
11. Participate in the development and review of standard operating procedures and policies related to clinical research.
12. Assist in the preparation and submission of annual reports and other required documentation to regulatory agencies.
13. Stay informed about changes in regulations and guidelines related to clinical research and make recommendations for updates to policies and procedures as needed.
14. Serve as a resource for investigators and study teams regarding regulatory requirements and processes.
15. Contribute to the continuous improvement of the clinical research program by identifying areas for improvement and making recommendations for process enhancements.

According to JobzMall, the average salary range for a Clinical Research Regulatory Specialist B in 3400 Spruce St, Philadelphia, PA 19104, USA is $60,000-$80,000 per year. However, salaries may vary depending on the specific job requirements, years of experience, and the employer's budget. It is always best to research the specific job posting or company for a more accurate salary range.

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.