Director of Clinical Research Operations

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Director of Clinical Research Operations

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.

Posted Job Title
Director of Clinical Research Operations

Job Profile Title
Director, Clinical Trials

Job Description Summary
Director, Clinical Trials
The Director of Clinical Research Operations will implement and oversee all operational aspects of research within the Radiation Oncology Clinical Trial Office (CTO) over the department's 19 locations including Lancaster General Hospital and Virtua Health. The incumbent will provide regulatory guidance and support to a diverse group of investigators ensuring compliance with investigator-initiated as well as sponsored projects (federal and non federal). This position will serve as a liaison between investigators, clinical research projects and clinical research support staff and will work closely with Administration to ensure that Clinical Trials Agreements are reviewed and negotiated in a timely and efficient manner.

Job Description

Director, Clinical Research Operations

The primary role of the Director of Clinical Research Operations is the organization, coordination and implementation of clinical trials, oversight and support of faculty and clinical research staff for the Radiation Oncology Clinical Trial Office. The essential functions of the position include but are not limited to:

Leadership position responsible for the management of the department's CTO within the University of Pennsylvanian Health System. Ensures that work is carried out in strict accordance with clinical research protocols, Standard Operating procedures and in compliance with Good Clinical Practices. Establishes, maintains, and continuously refines structure to ensure the supervision and management of clinical research support staff within the CTO at the University of Pennsylvania Health System.

Responsible for providing appropriate structure and systems to maintain oversight of data collection and management in accordance with trial protocols. Responsible for oversight of maintenance of source documents and case report forms. Collect and report timely, valid accurate data, maintain individual patient records. Maintain study compliance and integrity through close collaboration with investigator as well as the patient.

Works with Investigators, business office, grant administrators, and legal counsel to oversee efficient negotiation of Collaborative Research Agreements, Clinical Trial Agreements, Material Transfer Agreements and budget generation. Establish professional and effective relations with University partners to ensure that negotiations stay on track and are completed in a timely manner. Builds trust and inaugurates both informal and formal relationship networks both internal and external to PENN Medicine.

Supervises Associate Director and ensures that there is adequate training, assistance, guidance and support to investigators, coordinators and other research support staff in matters related to regulatory compliance. Scope to include monitoring and quality assurance activities for ongoing research as needs are identified, including serving as monitor for INDs and IDEs held by investigators, and assist investigators in the preparation for internal and external audits. Assist sponsor-investigators in IND and IDE management, including writing portions of IND/IDE applications, preparing progress reports and amendments, corresponding with FDA officials. Interface with sponsors, regulatory authorities and University research support offices, specifically the Institutional Review Board and the Office of Human Research.

Provides metrics to COO, Vice Chair of Strategic Research Operations and other departmental leaders to monitor CTO activities to include number and types of trials, enrollment, staff productivity, protocol activation, and resource requirements. Works with Director on annual budget planning as well as long term strategic and financial planning to confirm resource needs are commensurate with the long term growth of the program. Assists with the preparation of business plans to support resource requests.

Reports to Vice Chair of Strategic Clinical Research and COO to ensure that research priorities and needed resources are aligned, keep abreast of changes in both clinical, scientific and regulatory changes. Works with them to identify resource needs, implements appropriate changes and provide clear communication to faculty and staff.

Works with Medical Director and Associate Director of Clinical Research to prepare and present to the CRU Advisory Board. Prepares and maintains documents and metrics necessary to guarantee the CRU maintains and improves its good standing as a funded component of the NCI's Cancer Center Support Grant.

Qualifications

Bachelor's degree required with 7-10 years of experience in clinical research, data management, medical industry/CRO or equivalent combination of education and experience required. Position also requires an articulate individual with a strong background in management of clinical research regulations. Must possess excellent oral and written communication skills as well as the ability to work independently and also as part of a team. Strong planning and organizational capabilities along with problem solving skills desired. Must be able to work flexible hours. Must be able to communicate comfortably and effectively with regulatory authorities/sponsors/investigators. Requires strong attention to detail in composing and proofing written materials. Superior computer skills with MS Word, Excel, PowerPoint, electronic medical records and database systems such as Redcap is required. Knowledge of GCP guidelines is a must.

Job Location - City, State
Philadelphia, Pennsylvania

Department / School
Perelman School of Medicine

Pay Range
$72,837.00 - $138,391.00

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/Perelman-Center-for-Adv-Medicine/Director-of-Clinical-Research-Operations_JR00041516-1

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