Associate Director, Project Management & Compliance (CRCU)

Associate Director, Project Management & Compliance (CRCU)

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 Employers By State in 2021.

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.

COVID-19 vaccination is a requirement for all positions at the University of Pennsylvania. New hires are expected to be fully vaccinated before beginning work at the University. For more information about Penn's vaccine requirements and the use of Penn Open Pass, visit the Penn COVID-19 Response website for the latest information.

Posted Job Title
Associate Director, Project Management & Compliance (CRCU)

Job Profile Title
Associate Director E

Job Description Summary
The Clinical Research Computing Unit (CRCU) is an Academic Clinical Research Organization within the Center for Clinical Epidemiology and Biostatistics (CCEB) in the Perelman School of Medicine at the University of Pennsylvania. Since its inception in 1997, the CRCU has been expertly providing the full range of services essential for the conduct of clinical research projects, including Phase I-IV, multi-center, randomized, clinical trials, registry, and cohort studies utilizing state-of-the-art technology and tools to ensure superior data quality. The CRCU provides expertise in project management, data coordination and research computing tailored to meet your project requirements. The CRCU project teams partner with the Biostatistics Analysis Center (BAC) in the project design phase to plan accurate and precise data collection modules and to structure project reports for steady oversight. We specialize in study design and development, site management and training, data collection, processing, quality control, regulatory requirements and reporting, database development, administration, security, data storage and proposal development.

This position is contingent upon grant funding.

Job Description

This is a senior level strategic position with primary responsibilities and perspective to define, direct, and be held accountable for the mission of the CRCU and specifically Project Operations and Compliance. Position will function as a champion of research excellence to the department's clients and throughout the University, fostering a culture of customer service and responsiveness to customer needs. This position is responsible to develop strong working relationships within CCEB and Perelman SOM, as well as with collaborators throughout PENN and partner institutions. It includes direct and indirect staff supervision responsibilities, departmental, and financial responsibilities.

  • Provide strategic and operational direction and leadership to the CRCU team with respect to project operations and compliance activities. Effectively communicate, implement, monitor and administer solutions to support existing and new clinical research programs.
  • Provide compliance oversight to CRCU project sand serve as the regulatory resource and IRB liaison for the project management team and the CRCU as a whole. Ensure regulatory compliance and training requirements are achieved and documented.
  • Serve as research operations expert to collaborating investigators with respect to CRCU services in conjunction with grant proposal development. Oversee and provide specific content to the proposal development process, partner with investigators and research teams to produce high quality, innovative research plans.
  • Manage research operations for assigned studies. This includes study design, collaboration and direction of CDM and RT staff, protocol /MOP development, site initiation and training plans, regulatory oversight, monitoring metrics and reporting, and addressing day-to-day project issues for multi-site clinical research networks. Serve as a liaison to NIH project officers, principal and site investigators, lab management, biostatisticians, ancillary and publication groups.
  • Participate in CRCU and Project Operations and Compliance training initiatives

  • Master's Degree in a health related discipline plus five to seven years of relevant work experience involving clinical research, clinical center operations, regulatory requirements, and project planning activities or equivalent combination of education and experience required. Seven to ten years of experience preferred.
  • Significant work experience (greater than seven years) related to the clinical research, clinical center operations, and project planning. Significant experience involving diverse internal and external institutional and industry entities and multi-site, multi-institution research programs. This experience should include responsibility for professional commitment to cooperatively established objectives.
  • Significant knowledge (greater than seven years) of Project Management business practices and principals, standards and procedures and regulatory guidelines is required.
  • Excellent oral and written communication skills. A demonstrated ability to effectively present complex information is required, including managing projects, meetings, etc. in person as well as in a remote environment. The ability to interact effectively with many levels of faculty, staff, and administrative personnel is required.

Job Location - City, State
Philadelphia, Pennsylvania

Department / School
Perelman School of Medicine

Pay Range
$72,837.00 - $116,539.66

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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