Clinical Research Monitoring Specialist Senior, Office of Clinical Research
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.
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.
Job Description Summary
The Perelman School of Medicine at the University of Pennsylvania is the oldest and one of the finest medical schools in the United States. Penn is rich in tradition and heritage and at the same time consistently at the forefront of new developments and innovations in medical education and research. Since its founding in 1765 the School has been a strong presence in the community and prides itself on educating the leaders of tomorrow in patient care, biomedical research, and medical education. http://www.med.upenn.edu/
Clinical Research Monitoring Specialist Senior is an integral member of the Office of Clinical Research (OCR) in the Perelman School of Medicine. The Sr. Clinical Research Monitoring Specialist will:
- Plan, schedule and conduct regulatory compliance reviews of Penn Faculty and University held IND/IDE’s and international regulatory filings. Compliance Reviews focus on all aspects of clinical research execution to ensure activities are in compliance with applicable federal, international and local regulations, and established University of Pennsylvania policies and procedures.
- Routine reviews may include compliance with regulatory requirements of the Sponsor Trial Master Files, FDA correspondences, sponsor oversight or the project, Investigator compliance with the protocol and institutional policies and procedures.
- Summarize and present compliance review findings to the study staff and assist with corrective and preventative action plans.
- Is responsible for proactive noncompliance issue identification, escalation and management.
- Participate in regulatory authority (FDA) pre-inspection preparation, inspection, and post-inspection activities to promote the successful outcome of the inspection.
- Provide interpretation, guidance and education regarding clinical quality related regulations / guidelines (FDA, ICH, etc.) and University procedures to help support the clinical research teams at the University of Pennsylvania.
- Maintain current knowledge of FDA/GCP/GMP standards and Regulatory Guidance.
- Onboard and train new staff.
Bachelor's Degree and 5-7 years experience or equivalent combination of education and expereince required.
Job Location - City, State
Department / School
Perelman School of Medicine
$59,703.00 - $113,435.00
Affirmative Action Statement
Penn adheres to a policy that prohibits discrimination on the basis of race, color, sex, sexual orientation, gender identity, religion, creed, national or ethnic origin, citizenship status, age, disability, veteran status, or any other legally protected class.
Background check required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.