The Program Director-Multi-Site Clinical Research is responsible for overseeing, managing, facilitating, organizing and coordinating all aspects of the expansive and continuously growing ACC multi-site clinical research portfolio which includes 77 projects at more than 165 locations (nationally and internationally). The Program Director is responsible for building and maintaining relationship across the ACC matrix including six Penn-owned hospitals, Penn’s network, affiliates and the Children’s ... more details
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
Program Director Multi-site Clinical Research (Abramson Cancer Center)
Job Profile Title
Associate Director, Clinical Research Quality
Job Description Summary
The Program Director-Multi-Site Clinical Research is responsible for overseeing, managing, facilitating, organizing and coordinating all aspects of the expansive and continuously growing ACC multi-site clinical research portfolio which includes 77+ projects at more than 165 locations (nationally and internationally). The Program Director is responsible for building and maintaining relationship across the ACC matrix including six Penn-owned hospitals, Penn’s network, affiliates and the Children’s Hospital of Philadelphia, as well as with external cancer centers, academic medical centers and their affiliates to provide the highest level of support is provided to Penn investigators to ensure successful clinical trials in compliance with institutional, local and federal and international requirements.
Job Description
Process Improvement and Quality Control:
- Identify deficiencies and develop new workflows and process improvements to rapidly and prospectively identify qualifying studies that ACC investigators plan to conduct at sites outside of the central Abramson Cancer Center location, and work in coordination with managers of other DOCM units to ensure rapid and complete approval of each site.
- Develop and implement Standard Operating Procedures, Manuals of Procedures, Best Practices and Work Instruction documents to guide every aspect of the multi-site clinical trial programs.
- Train internal and external study teams to ensure compliance and operational efficiencies to reduce non-compliance and protect subject safety/
- Work closely with IT to build study site profiles in multiple database applications to ensure rapid collection of research data for internal analytics and rapid reporting to the NCI per requirements ensuring full compliance with core grant mandates.
- Generate data reports and analytics for the DOCM Director as requested to facilitate DOCM Quality Control and Quality Assurance activities.
Collaboration and Team Building:
- Work closely with the DOCM Administrative Directors to ensure subject safety data from all study sites is collected per FDA, NCI and international regulations, reported to the DSMC in a high-quality and timely manner, the data meet the quality control standards for reporting to, and analysis by, the ACC Data and Safety Monitoring Committee;
- Work closely with and support the DOCM Audit and Compliance Unit to coordinate DOCM audits with the sites, and internationally contracted vendors, ensure audits are conducted at each site per ACC policies and the study-specific customized audit plan;
- Establish electronic collaboration and document sharing accounts and develop and maintain electronic files structures to support ACC oversight.
- Work hands-on with study teams at all locations post-audit to ensure ACC mandated Correction and Preventative Action Plans are implemented and operationalized per regulatory requirements.
- Work directly with the DOCM Data Management team to ensure study site activation statuses are maintained to a high level of compliance, ensure study subjects are assigned to appropriate site locations, and data are reported appropriately to the ACC and the NCI.
- Create a new system to track financial agreements for each multi-site study and performance milestones to facilitate billing for DOCM activities. Work collaboratively with ACC Finance to ensure ongoing billing accuracy.
- Serve as liaison between the DOCM and the study sites for Medical Monitoring and independent DSMB activities and prepare reports that allow close tracking and assessment of all aspect of the ACC multi-site research portfolio.
- Hire, train and oversee a team of Multi-Site Program Coordinators and ensure consistent performance, and compliance standards are met across the entire Multi-Site Program matrix including international employees hired through contracts organization.
Communication:
- Serve as the main point of contact to all internal and external stakeholders participating in the multi-site research program.
- Develop and maintain listserv and informational materials related to the multi-site program.
- Establish a multi-site special interest group to gather information for stakeholders related to ongoing visions and needs for multi-site research, produce reports for the DOCM Director to help steer the direction of the program and identify opportunities for improvement and growth.
Qualifications: Minimum of a Master of Science, Master of Arts, and at least 10 years of experience or equivalent combination of education and experience is required . Academic Cancer Center experience is a strong 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, be flexible and have the ability to build and maintain positive working relationships at all levels of the institution and with our external research collaborators..
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.
Position contingent upon funding.
Job Location - City, State
Philadelphia, Pennsylvania
Department / School
Perelman School of Medicine
Pay Range
$106,400.00 - $139,520.00 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
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 dependent children can get tuition assistance here at Penn. Your dependent children are also eligible for tuition assistance at other institutions.
Retirement: Penn offers generous retirement plans to help you save for your future. Penn’s Basic, Matching, and Supplemental retirement plans allow you to save for retirement on a pre-tax or Roth basis. Choose from a wide variety of investment options through TIAA and Vanguard.
Time Away from Work: Penn provides you with a substantial amount of time away from work during the course of the year. This allows you to relax, take vacations, attend to personal affairs, recover from illness or injury, spend time with family—whatever your personal needs may be.
Long-Term Care Insurance: In partnership with Genworth Financial, Penn offers faculty and staff (and your eligible family members) long-term care insurance to help you cover some of the costs of long-term care services received at home, in the community or in a nursing facility. If you apply when you’re newly hired, you won’t have to provide proof of good health or be subject to underwriting requirements. Eligible family members must always provide proof of good health and are subject to underwriting.
Wellness and Work-life Resources: Penn is committed to supporting our faculty and staff as they balance the competing demands of work and personal life. That’s why we offer a wide variety of programs and resources to help you care for your health, your family, and your work-life balance.
Professional and Personal Development: Penn provides an array of resources to help you advance yourself personally and professionally.
University Resources: As a member of the Penn community, you have access to a wide range of University resources as well as cultural and recreational activities. Take advantage of the University’s libraries and athletic facilities, or visit our arboretum and art galleries. There’s always something going on at Penn, whether it’s a new exhibit at the Penn Museum, the latest music or theater presentation at the Annenberg Center, or the Penn Relays at Franklin Field to name just a few examples. As a member of the Penn community, you’re right in the middle of the excitement—and you and your family can enjoy many of these activities for free.
Discounts and Special Services: From arts and entertainment to transportation and mortgages, you'll find great deals for University faculty and staff. Not only do Penn arts and cultural centers and museums offer free and discounted admission and memberships to faculty and staff. You can also enjoy substantial savings on other goods and services such as new cars from Ford and General Motors, cellular phone service plans, movie tickets, and admission to theme parks.
Flexible Work Hours: Flexible work options offer creative approaches for completing work while promoting balance between work and personal commitments. These approaches involve use of non-traditional work hours, locations, and/or job structures.
Penn Home Ownership Services: Penn offers a forgivable loan for eligible employees interested in buying a home or currently residing in West Philadelphia, which can be used for closing costs or home improvements.
Adoption Assistance: Penn will reimburse eligible employees on qualified expenses in connection with the legal adoption of an eligible child, such as travel or court fees, for up to two adoptions in your household.
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To learn more, please visit: https://www.hr.upenn.edu/PennHR/benefits-pay
