Director-Clinical Research Compliance

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Director-Clinical Research Compliance

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
Director-Clinical Research Compliance

Job Profile Title
Director D

Job Description Summary
Director D
The Director of the Clinical Research Compliance Program is an integral member of the Office of Clinical Research (OCR) in the Perelman School of Medicine (PSOM) reporting to the Vice Dean for Clinical Research. The Position is responsible for implementing and maintaining a compliance program and operationalizing the components of the program in alignment with applicable laws and regulations and PSOM and University policy. The role has a direct reporting relationship to the Vice Dean and Chief Clinical Research Officer and indirectly reports to the University's Office of Audit, Compliance and Privacy.

The Director is responsible for directing PSOM's Clinical Research (CR) Compliance Program to ensure regulatory compliance across the research enterprise and provide senior level expertise and oversight for quality systems regarding all GCP activities. The Director will provide recommendations for clinical research best practice to the Senior Associate Vice Provost for Human Research, the Vice Provost of Research, the Institutional Review Board, the University Office of Research Integrity and the University Research Compliance Committee. The PSOM Compliance Program consists of setting best practices for clinical research conduct, contributing to the education of employees, working closely with the sponsor support team, communicating effectively with other related offices and auditing of clinical research activities for GCP compliance and adherence to fCOI management plans. Responsible for risk management activities for PSOM clinical trials, including leadership and contribution to the development of risk management and corrective action plans.

Job Description

Director D

The Director of the Clinical Research Compliance Program is an integral member of the Office of Clinical Research (OCR) in the Perelman School of Medicine (PSOM) reporting to the Vice Dean for Clinical Research. The Position is responsible for implementing and maintaining a compliance program and operationalizing the components of the program in alignment with applicable laws and regulations and PSOM and University policy. The role has a direct reporting relationship to the Vice Dean and Chief Clinical Research Officer and indirectly reports to the University's Office of Audit, Compliance and Privacy.

The Director is responsible for directing PSOM's Clinical Research (CR) Compliance Program to ensure regulatory compliance across the research enterprise and provide senior level expertise and oversight for quality systems regarding all GCP activities. The Director will provide recommendations for clinical research best practice to the Senior Associate Vice Provost for Human Research, the Vice Provost of Research, the Institutional Review Board, the University Office of Research Integrity and the University Research Compliance Committee. The PSOM Compliance Program consists of setting best practices for clinical research conduct, contributing to the education of employees, working closely with the sponsor support team, communicating effectively with other related offices and auditing of clinical research activities for GCP compliance and adherence to fCOI management plans. Responsible for risk management activities for PSOM clinical trials, including leadership and contribution to the development of risk management and corrective action plans.

Specifically, the Director will:

1. Lead the strategic planning, creation and implementation of the standardization for all compliance programs, activities and standard operating procedures across PSOM. 2. Be responsible for management, training, professional development and leadership of a team of two associate directors, nine auditors and one clincialtrial.gov coordinator, and the auditing activities of faculty and University-held INDs and IDEs, including providing oversight and leadership for the development of auditing schedules, the conduct of audits, review of compliance reports, adherence to protocol Data Safety and Monitoring Plans (DSMP)/Audit SOPs and identification of areas of risk and incorporation of risk mitigation plans into compliance activities.

3. Facilitate external audits, regulatory inspections, including FDA, NIH, Industry Sponsors, and follow clinical escalation procedures as applicable.

4. Author and/or contribute to SOPs regarding the conduct and oversight of clinical trials, including auditing.

5. Oversee and report on the management and compliance of PSOM clinicaltrials.gov submissions.

6. Be responsible for supporting the facilitation of research and education of the PSOM research community in partnership with all OCR units, the IRB, Office of Research Integrity, and the Abramson Cancer Center.

Qualifications:
  • Requires a MS in biomedical science, regulatory affairs, clinical research, nursing or related health sciences degree and 5-7 years of experience or equivalent combination of education and experience required; JD or PhD preferred. RAPs certification preferred.
  • 10 years of clinical research experience preferred with increasing responsibilities including team management, in one or more of the following areas, Academic Health Center, Pharmaceutical Industry, Contract Research Organization or Site Management Organization
  • Experience with FDA/federal agency inspections highly preferred.
  • A minimum of 5 years of previous monitoring or auditing experience required.
  • Advanced knowledge of federal research regulations and guidance, including but not limited to 21CFR Parts 11, 50, 54, 56, 312 and 812, 45 CFR 46 and ICH GCP guidance as well NIH, Conflict of Interest and CMS regulations and guidance.
  • Superior interpersonal and leadership skills with the ability to build and maintain effective professional relationships across a matrixed organizational structure in the health system, the PSOM and the University.
  • Ability to provide clear, pragmatic direction and advice regarding compliance issues.


Resume and cover letter required with application

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.

Job Location - City, State
Philadelphia, Pennsylvania

Department / School
Perelman School of Medicine

Pay Range
$88,861.00 - $168,837.00

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.

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

To apply, visit https://wd1.myworkdaysite.com/en-US/recruiting/upenn/careers-at-penn/job/AnatomyChemistry-Building/Director-Clinical-Research-Compliance_JR00043483-1

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