Clinical Research Monitoring Specialist Senior
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
Office of Clinical Research (OCR) in the Perelman School of Medicine and reports directly to the lead of the Clinical Site Operations (CSO) unit. The Sr. Clinical Research Monitoring Specialist is responsible for performing Good Clinical Practice (GCP) monitoring activities for University or faculty held Investigational New Drug (IND), Investigational Device Exemptions (IDE) and foreign Clinical Trial Applications (CTA) clinical research trials to verify human subjects are protected; the data are accurate, complete, and verifiable from source documents; and the conduct of the trial follows the approved protocol.
The Senior Clinical Research Monitoring Specialist is an integral member of the Office of Clinical Research (OCR) in the Perelman School of Medicine and reports directly to the lead of the Clinical Site Operations (CSO) unit. The Sr. Clinical Research Monitoring Specialist is responsible for performing Good Clinical Practice (GCP) monitoring activities for University or faculty held Investigational New Drug (IND), Investigational Device Exemptions (IDE) and foreign Clinical Trial Applications (CTA) clinical research trials to verify human subjects are protected; the data are accurate, complete, and verifiable from source documents; and the conduct of the trial follows the approved protocol.
The Senior Clinical Research Monitoring Specialist will:
- Develop and maintain risk based monitoring plans to ensure quality and integrity of data, protection of human subjects, the trial is conducted in compliance with the study documents, GCP, and applicable regulations.
- Participate in sponsor development meetings and Data Safety Monitoring Board (DSMB) meetings to review, contribute and present on the progress of ongoing clinical trials.
- Conduct or oversee vendors conducting initial, interim and close out monitoring visits in adherence to: the study-specific Data Safety Monitoring Plan (DSMP); protocol; applicable regulatory requirements; Sponsor Standard Operating Procedures (SOPs); and GCP/ICH guidelines.
- Confirm appropriate documentation pertaining to investigational product storage, accountability, administration and chain of custody for each subject and to confirm only enrolled subjects receive investigational product.
- Assess investigator oversight of the trial.
- Perform the Principal Investigator (PI) compliance training and site compliance management. Develop and implement corrective action plans, and communicate progress to Sponsor Regulatory team, and follow-up to ensure appropriate resolution of identified issues.
- Ensure timely development and reporting of monitoring visit reports and follow up letters.
- Bachelor’s degree required. Masters preferred.
- A minimum of 5 years to 7 years of experience or an equivalent combination of education and experience is required. Work experience in clinical/translational research compliance and/or operations in any of the following areas: Academia, Pharmaceutical, Contract Research Organization (academic or private sector) or Site Management Organization (academic or private)
- Direct experience in the following areas preferred:
- Compliance oversight for clinical trials; monitoring or auditing
- Advanced knowledge of regulations governing human research, including 21 CFR Parts 11, 50, 54, 56, 312 and 812, 45 CFR 46, and ICH Good Clinical Practice guidelines
- Ability to respect and protect highly sensitive and confidential information
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.