University of Pennsylvania Hiring for Director, Clinical Research Operations & Compliance – Penn Dental Medicine at Penn Dental at Schattner Center Full Time

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 TitleDirector, Clinical Research Operations & Compliance – Penn Dental MedicineJob Profile TitleDirector B, ResearchJob Description SummaryThe Director of Clinical Research Operations & Compliance will oversee all compliance and training activities within the Center for Clinical and Translational Research (CCTR). S/he will be responsible for the development of quality management plans, routine and for-cause monitoring of clinical research projects, staff training, and ensuring compliance with PDM clinical policies and procedures. This individual will directly supervise the dental professionals on the CCTR team (hygienists and assistants).Job Description

The Director of Clinical Research Operations & Compliance will be responsible for all research and clinic compliance and research training within the CCTR. S/he will be expected to have a thorough understanding of all institutional, state, and federal policies and regulations surrounding clinical research, and will be expected to stay abreast of all changes/updates to such standards. Specifically, this individual will be responsible for:

• Supervise clinic operations during the conduct of study visits; hold primary responsibility for patient/subject scheduling; perform inventory of study-related supplies and ensure that adequate materials are available at all times; liaise with clinical and research staff to ensure smooth and efficient operations.
• Work with the clinical research coordinators in the conduct of study visits which includes: supervising different research activities such as informed consent process; recruitment of potential subjects; organizing and running study visits; performing study assessments and procedures as appropriate based on training and education; and assisting with the collection, preparation, shipment, and/or storage of biological materials using universal precautions.
• Train and supervise dental hygienists with room set-up, break-down, and sterilization of medical/dental instruments.
• Directly supervising a team of dental hygienists and dental assistants, with managerial tasks to include hiring, annual and ad hoc performance management, managing schedules and time off requests, and overseeing project assignment and monitoring staff capacity.
• Developing and implementing quality management plans for all clinical research studies that are consistent with the risk level of each individual project.
• Performing routine and ad hoc monitoring for faculty- and student-run research to ensure that the projects fully comply with institutional policies, Good Clinical Practice, and state and federal regulations.
• Developing monitoring reports and presenting findings to key stakeholders.
• Training CCTR personnel and students on clinical research topics and maintaining appropriate records of all training activities.
• Liaising with Penn Dental leadership and ensuring that the CCTR clinic and laboratory/ies are in compliance with all policies and procedures.
• Serving as a resource to faculty, staff, and students on appropriate clinical research start-up, conduct, and close-out activities.
• Working with the Penn Dental Axium team to review and approve dental record request forms relating to research.
• As required, supervise the CRCs with quality control and quality assurance processes related to the study; implement study quality assurance and quality management plans; review study records, including study charts, case report forms, informed consent forms, and other essential documents, for accuracy and completeness; identify and seek appropriate correction of any errors or omissions within the study records; draft reports of quality assurance activities and provide such reports to the appropriate parties; assist in the development and implementation of corrective action plans as necessary.
• Submitting professional and timely routine and as-needed reports to the IRB, study sponsor, and other parties as required.
• Assisting with CCTR finance management, including purchasing, invoicing, budgeting, and reviewing monthly grant reports for accuracy.
• Identifying potential or ongoing problems, suggest viable solutions, and oversee or assist in their implementation.
• Performing other duties as required.

Qualifications

• Bachelor of Science, Bachelor of Arts, and 5 to 7 years of experience or equivalent combination of education and experience is required.

Salary to commensurate with experience.

Job Location – City, StatePhiladelphia, PennsylvaniaDepartment / SchoolSchool of Dental MedicinePay RangeSalary 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.

To learn more, please visit: https://www.hr.upenn.edu/PennHR/benefits-pay