Clinical Research Regulatory Specialist B

Are you passionate about ensuring ethical and regulatory compliance in clinical research? Do you have a strong background in regulatory affairs and a desire to make a difference in the field of medicine? If so, the University of Pennsylvania is seeking a driven and detail-oriented individual to join our team as a Clinical Research Regulatory Specialist B.In this role, you will play a crucial part in the development and oversight of clinical research studies at our prestigious institution. You will work closely with researchers, sponsors, and regulatory agencies to ensure that all studies are conducted in accordance with federal regulations and institutional policies. Your expertise in regulatory affairs will be essential in navigating complex protocols and ensuring timely and successful study approvals.We are looking for a highly organized and self-motivated individual with a Bachelor's degree and at least 3 years of experience in clinical research and regulatory affairs. The ideal candidate will have strong communication skills and a deep understanding of federal regulations and guidelines pertaining to clinical research. If you are ready to take on a challenging and rewarding role in the ever-evolving field of clinical research, we encourage you to apply for this position at the University of Pennsylvania.

1. Develop and maintain a thorough understanding of federal regulations and institutional policies pertaining to clinical research.
2. Work closely with researchers, sponsors, and regulatory agencies to ensure compliance with all applicable regulations and policies.
3. Review and approve study protocols, informed consent forms, and other study-related documents for regulatory compliance.
4. Assist in the preparation and submission of regulatory documents to obtain study approvals.
5. Monitor ongoing studies to ensure continued compliance with regulations and policies.
6. Keep abreast of any changes in regulations and policies and communicate them to relevant stakeholders.
7. Serve as a resource for researchers and study staff regarding regulatory requirements and best practices.
8. Participate in training and educational programs to promote understanding and compliance with regulations and policies.
9. Maintain accurate and organized records of all regulatory documents and correspondence.
10. Collaborate with other team members to develop and implement strategies for efficient and compliant study processes.
11. Identify and address potential regulatory issues and provide solutions to ensure timely study approvals.
12. Assist in the preparation of reports and presentations for institutional review boards and regulatory agencies.
13. Represent the institution in meetings and interactions with regulatory agencies.
14. Keep track of and ensure timely renewal of study approvals and necessary reporting to regulatory agencies.
15. Stay up-to-date with industry trends and developments in clinical research regulations and policies.
16. Adhere to ethical standards and maintain confidentiality of sensitive information related to clinical research.
17. Perform other related duties as assigned by the supervisor.

According to JobzMall, the average salary range for a Clinical Research Regulatory Specialist B is between $57,000 and $80,000 per year. However, this can vary depending on factors such as location, experience, and employer. Some individuals in this role may earn higher salaries, up to $100,000 or more, particularly in larger research organizations or with advanced education and experience.

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.