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.
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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/
Reporting directly to the Manager, DOCM Operation within the Abramson Cancer Center and indirectly to the Chief ACC Compliance Officer- Clinical Research, the Clinical Trials Scientific Review and Monitoring (CTSRMC) Coordinator is responsible for coordination of the initial, ongoing and annual review of protocols assigned to the CTSRMC. This includes pre-reviewing submissions assigned to the convened CTSRMC for completeness and compliance with NCI, federal and institutional regulations/policies; pre-reviewing submissions eligible for expedited review and working with researchers and research staff to resolve issues related to convened or expedited review. He/she prepares meeting agendas; assigns scientifically appropriate protocols to CTSRMC members to review; attends convened meetings; and maintains thorough and complete notes on the discussion. He/she prepares complete accurate minutes of the meeting including attendance, actions taken, the vote on these actions, the basis for requiring changes in or disapproving research, and a written summary of controverted issues and their resolution. The CTSRMC Coordinator prepares written correspondence to investigators of all CTSRMC actions and decisions. The CTSRMC Coordinator reviews claims of exemptions and expedited reviews as assigned and determines the appropriate level of review and assigns scientific or statistical reviewer as appropriate to the type of study. He/she is the main source of contact between CTSRMC Chair, CTSRMC member/reviewers and investigators. He/she maintains minutes, CTSRMC rosters, CTSRMC electronic files and all other required regulatory documents in compliance with federal regulations, institutional policies, and ACC SOPs. In contacts with investigators the CTSRMC Coordinator provides guidance on issues related to CTSRMC regulations and CTSRMC actions. The CTSRMC Coordinator participates, as assigned, in research community outreach and training activities; as well as CTSRMC member training and CTSRMC quality improvement initiatives including the review of existing CTSRMC policies and procedures. The CTSRMC Coordinator will interact directly with Penn’s IRB to create harmonization of review of study protocols. Additionally, the CTSRMC Coordinator is responsible for maintaining a database of information related to CTSRMC activities and generating reports that are used by ACC leadership and the NCI.
POSITION IS CONTINGENT UPON FUNDING
Minimum of a BA/BS in biological sciences or a relevant discipline and 3-5 years of experience directly related to clinical research or an equivalent combination of education and experience required.
Detailed knowledge of applicable regulations related to clinical research. Knowledge of scientific review in an academic cancer center is a plus. Demonstrated project and time management skills are necessary; must be able to work independently with minimal supervision. Outstanding organizational skills and the ability to function in a team environment are required. Qualified candidates must also demonstrate excellent written and verbal communication skills; advanced computer software skills; a clear attitude of customer service; must be able to work in a face-paced environment with time sensitive deadlines and competing priorities; the ideal candidate will have very strong analytical and critical thinking skills, and the ability to build and maintain positive working relationships at all levels of the institution.
This job description is not intended to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
Job Location - City, State
Department / School
Perelman School of Medicine
$42,953.00 - $77,315.00
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.