Clinical Research Regulatory Specialist C

Trustees of University of Pennsylvania; Upper Paxton Township (PA); Vor Ort; USD 76.000 - 78.000; Vollzeit

Zusammenfassung

The University of Pennsylvania's Perelman School of Medicine in Philadelphia seeks a Clinical Research Regulatory Specialist C to oversee regulatory operations for NIH and industry-sponsored trials. You will manage submissions to IRBs, sponsors, CROs, FDA, and regulators, ensuring compliance and study integrity.

You will develop regulatory tools and provide expert guidance, mentoring junior staff in regulatory practices and study oversight while coordinating with investigators, nursing units,

Qualifikationen

• Bachelor's degree and 5 to 7 years of experience or equivalent combination of education and experience is required.
• Experience leading regulatory operations for clinical trials.
• Knowledge of NIH/industry-sponsored regulatory requirements.

Aufgaben

• This position will be a resource for regulatory management and oversight with NIH and Industry-sponsored clinical trials.
• Lead regulatory operations for clinical research and submissions to IRBs, sponsors, CROs, FDA, and regulators.
• Develop regulatory tools, guidance, and mentor junior staff in regulatory practices.

Kenntnisse

Regulatory compliance

Clinical research

IRB submissions

Regulatory oversight

Ausbildung

Bachelor's degree

Jobbeschreibung

University Overview

The University of Pennsylvania, the largest private employer in Philadelphia, is a world-renowned leader in education, research, and innovation. This historic, Ivy League school consistently ranks among the top 10 universities in the annual U.S. News & World Report survey. Penn has 12 highly-regarded schools that provide opportunities for undergraduate, graduate and continuing education, all influenced by Penn's distinctive interdisciplinary approach to scholarship and learning. As an employer Penn has been ranked nationally on many occasions with the most recent award from Forbes who named Penn one of America's Best Large Employers in 2023.

Penn offers a unique working environment within the city of Philadelphia. The University is situated on a beautiful urban campus, with easy access to a range of educational, cultural, and recreational activities. With its historical significance and landmarks, lively cultural offerings, and wide variety of atmospheres, Philadelphia is the perfect place to call home for work and play.

The University offers a competitive benefits package that includes excellent healthcare and tuition benefits for employees and their families, generous retirement benefits, a wide variety of professional development opportunities, supportive work and family benefits, a wealth of health and wellness programs and resources, and much more.

Posted Job Title

Clinical Research Regulatory Specialist C

Job Profile Title

Clinical Research Regulatory Specialist C

Job Description Summary

This position will be a resource for best practices of regulatory management and oversight with NIH and Industry-sponsored clinical trials in the Neuroradiology Clinical Research Division. The position involves leading regulatory operations for clinical research, independently managing submissions to IRBs, committees, sponsors, CROs, FDA, and regulatory agencies. He/She will oversee regulatory documentation, resolve complex compliance issues, direct study initiation, monitoring, audit, and close-out visits. He/She will serve as a liaison for regulatory oversight with investigational teams, nursing units, sponsors, and CROs. Other responsibilities include the development of regulatory tools and processes, providing expert regulatory and compliance guidance, and training/mentoring junior staff in regulatory practices and study oversight.

Job Description

Job Responsibilities

This position will be a resource for best practices of regulatory management and oversight with NIH and Industry-sponsored clinical trials in the Neuroradiology Clinical Research Division. The position involves leading regulatory operations for clinical research, independently managing submissions to IRBs, committees, sponsors, CROs, FDA, and regulatory agencies. He/She will oversee regulatory documentation, resolve complex compliance issues, direct study initiation, monitoring, audit, and close-out visits. He/She will serve as a liaison for regulatory oversight with investigational teams, nursing units, sponsors, and CROs. Other responsibilities include the development of regulatory tools and processes, providing expert regulatory and compliance guidance, and training/mentoring junior staff in regulatory practices and study oversight.

Perform additional regulatory duties as assigned.

Position is Contingent upon Grant Funding

Qualifications

Bachelor's degree and 5 to 7 years of experience or equivalent combination of education and experience is required.

Job Location - City, State

Philadelphia, Pennsylvania

Department / School

Perelman School of Medicine

Pay Range

$75,804.00 - $77,920.00 Annual Rate Salary offers are made based on the candidate's qualifications, experience, skills, and education as they directly relate to the requirements of the position, and in alignment with salary ranges based on external market data for the job's level. Internal organization and peer data at Penn are also considered.

Equal Opportunity Statement

The University of Pennsylvania is an equal opportunity employer. Candidates are considered for employment without regard to race, color, sex, sexual orientation, religion, creed, national origin (including shared ancestry or ethnic characteristics) , citizenship status, age, disability, veteran status or any class protected under applicable federal, state or local law .

Special Requirements

Background checks may be required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.

University Benefits

Health, Life, and Flexible Spending Accounts : Penn offers comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits to protect you and your family's health and welfare. You can also use flexible spending accounts to pay for eligible health care and dependent care expenses with pre-tax dollars.

Tuition : Take advantage of Penn's exceptional tuition benefits . You, your spouse, and your