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
Manager Research Project A (Department of Dermatology)
Job
Profile Title
Manager Research Project A
Job Description Summary
The Project Manager will manage the
day-to-day operations of investigator-initiated health disparities and equity focused clinical research studies with various funding
sponsors (government, industry, foundation). The primary responsibilities of the Project Manager will range from planning and developing
guidance materials, data collection methods, and tracking systems for study operations to monitoring external site performance and study
close-out procedures. As a leadership role within the lab, the Project Manager will supervise research coordinators and take the lead in
cultivating effective relationships with various collaborators, sponsors, and community partners. The Project Manager will be responsible
for ensuring regulatory compliance by all sites relying on Penn’s IRB as the Central IRB and overseeing regulatory compliance by sites
operating under their own institution’s IRB. The ideal candidate for this position will have the ability to manage a dynamic pace and varied
research- related responsibilities in accordance with University of Pennsylvania, GCP, FDA, and other governing-entity
guidelines.
Job Description
Job Responsibilities
Develop and
maintain study documents including protocols, consents, manuals of operations and procedures, data and specimen collection forms, training
materials, marketing materials, site outreach materials, and study/data presentation materials in various formats.
Identify and lead
collaboration with various departments and external organizations, such as IDS, CRCU, CHPS, collaborating academic medical centers,
community organization, private practice physicians, etc. as needed for study operations.
Lead the training and oversee
implementation of study procedures of external study sites.
Oversee all research visit activities including recruiting, screening,
enrolling and data and/or sample collection, data and/or sample transmission for assigned research studies.
Implement regulatory plans for multi-site studies, effectively assigning team members as
needed for preparation of regulatory documentation.
Prepare and track all regulatory submissions for assigned studies including
initial reviews, modifications, continuing reviews, deviations, and study close-outs.
Ensure regulatory compliance by all sites
relying on Penn’s IRB as the Central IRB and overseeing regulatory compliance by sites operating under their own institution’s IRB, if
applicable.
Prepare and submit all required documentation and reports for SAEs and protocol deviations per UPenn, sponsor, FDA and
other applicable regulating entity requirements
Lead the organizational planning for
electronic data capture systems (EDCs) and track the build-out and maintenance of the EDCs for each assigned project ensuring data is
collected and stored in accordance with HIPAA and University guidelines.
Oversee data entry, tracking data quality and completeness,
and monitoring completion of study procedures at internal and external study sites.
Review interim and final data reports to identify
and address missing data and data discrepancies.
Prepare and maintain data reports for progress reporting to investigators, funding
sponsor, collaboration institutions, and community partners.
Coordinate and facilitate
project meetings including setting agendas, reserving conference rooms or sending virtual meeting information.
Adhere to all
University of Pennsylvania, GCP, and FDA guidelines.
Position involves work-related responsibilities that may occur outside of usual
M-F 8am-5pm business hours.
Perform additional duties as need to ensure success of project and lab
operations.
Qualifications
This position is contingent upon funding.
Job Location – City, State
Philadelphia,
Pennsylvania
Department / School
Perelman School of Medicine
Pay Range
$51,824.00 –
$75,000.00 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, as well as internal and market factors and grade profile.
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.
Special Requirements
Background check required after a conditional job offer is made. Consideration of the
background check will be tailored to the requirements of the job.
University Benefits
To learn more, please visit: https://www.hr.upenn.edu/PennH
R/benefits-pay
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