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Regulatory Project Manager (Department of Neurology)
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Position Number: 5632140
Location: Philadelphia, PA
Position Type: Health - Healthcare Administration

Regulatory Project Manager (Department of Neurology)

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
Regulatory Project Manager (Department of Neurology)

Job Profile Title
Manager Research Project A

Job Description Summary
This position is based in the Penn Frontotemporal Degeneration Center, part of the Department of Neurology of the University of Pennsylvania's Perelman School of Medicine. The purpose of this position is to be responsible for regulatory activities in a large translational research center with federally funded (NIH, NIA, etc.), foundation funded, and industry funded clinical and non-clinical research projects, including early phase, complex clinical trials and large federal grants, supporting a robust research program studying patients with rare early-onset neurodegenerative disease.

In collaboration with Principal Investigators and the FTDC Clinical Research Program Director, the Regulatory Project Manager will take a leadership role in writing, submitting, implementing and continued management of investigator-initiated protocols. Independently facilitate the preparation, submission, review and approval process for for observational studies, Phase I - IV trials through the IRB, the sponsor, CAMRIS, RRSC, FDA, INDSO, and all other reviewing entities as applicable. This is to include new submissions, continuing reviews, amendments, adverse events, and other reportable events. Other duties include, but are not limited to: Prepare/process all required regulatory documentation for pharmaceutical companies, contract research organizations (CROs), sponsor companies, etc.; Drafting informed consent forms and other documents associated with these protocols; Managing Penn CRMS, PennBox folders, other regulatory tracking systems; Developing, organizing, and maintaining all regulatory affairs documentation/files as required including training documentation, CVs, licenses, etc. ; resolve regulatory and data queries as required; participate in site initiation, site monitoring, study audit and close-out visits; participate in study team meetings and ongoing protocol training/compliance meetings. Provide support to study/trial start-up process, including budgeting, invoice tracking, etc.; help coordinate complex projects conducted with internal and external collaborators; ensure that studies/research are conducted safely and according to protocol, provide input to the team conducting study/interventions and collaborate with peers from other Universities and funding agencies; help coordinate grant applications and interact with funding administrators and other university personnel; Assist FTDC Clinical Research Program Director and others with on-boarding and orienting new staff; Provide direct regulatory/compliance guidance and oversight of investigator-initiated studies/trials and investigator-initiated multi-site studies/trials; Oversee compliance and quality assurance activities within the FTD Center; SOP development and implementation; Work with investigators, study coordinators, and other managers for development/maintenance of study specific case report forms and source document tools; Maintaining University of Pennsylvania, FDA, and GCP standards and guidelines.

The Regulatory Project Manager will report directly to the FTDC Clinical Research Program Director.

Job Description

Job Responsibilities

Independently manage regulatory needs of clinical and non-clinical trials and studies across the FTD Center; Independently facilitate the preparation, submission, review and approval process for studies/trials with all internal and external reviewing entities; Assist with writing, submitting, implementing and continued management of investigator-initiated protocols; Independently prepare and process all regulatory documentation for observational studies, Phase I - IV trials through IRB, and all applicable regulatory review committees- including new submissions, continuing reviews, amendments, adverse events, and reportable events; Develop, organize, and maintain all regulatory affairs documentation/files as required including training, CVs, licenses, etc.; Resolve regulatory and data queries as required; Participate in site initiation, study monitoring, study audit and close-out visits; Participate in study team meetings and ongoing protocol training/compliance meetings.; Provide direct regulatory/compliance guidance and oversight for the Penn FTDC research portfolio; Facilitate the process of study/trial startup along side FTDC Clinical Research Program Director; SOP development and implementation; Work with investigators and project manager, development/maintenance of study specific case report forms and source document tools; Ensure that studies/research are conducted safely and according to protocol; Collaborate with peers from other Universities and funding agencies; Assist with on-boarding and orienting new staff members.
The position may require communication with patients, staff, and other stakeholders outside of office hours. Hours are flexible to adapt to protocol and reporting requirements, and may include evenings or weekends as necessary. The position is contingent on continued funding.

Hiring range minimum for this position is $70,958.

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.

Qualifications

Bachelor of Science and 3 to 5 years of experience or equivalent combination of education and experience is required.
Preferred: Master's Degree with 2-5 years of research experience. The Regulatory Project Manager should be highly motivated and detail-oriented, have strong planning, organizational, multi-tasking, and prioritizing capabilities, and be capable of problem solving issues as they arise, but willing to seek help as appropriate to complete the work accurately and efficiently. The Regulatory Project Manager should strong written and verbal communication skills, possess effective problem-solving abilities, strong organizational and time management skills, and be flexible and able to multi-task. The Regulatory Project Manager should possess the ability to work independently and as part of a team. Prior experience with/knowledge of IRB, clinical trial/clinical research study start-up, human research protection regulations, industry-sponsored trials, early phase trials, ethics committees and/or gene and molecular therapies is preferred.

Job Location - City, State
Philadelphia, Pennsylvania

Department / School
Perelman School of Medicine

Pay Range
$51,824.00 - $74,000.00 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.

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/HUP/Regulatory-Project-Manager--Department-of-Neurology-_JR00096939-1