Clinical Research Regulatory Specialist B

Clinical Research Regulatory Specialist B University Overview The University of Pennsylvania, the largest private employer inPhiladelphia, is a world-renowned leader in education, research,and innovation. This historic, Ivy League school consistently ranksamong the top 10 universities in the annual U.S. News & WorldReport survey. Penn has 12 highly-regarded schools that provideopportunities for undergraduate, graduate and continuing education,all influenced by Penn's distinctive interdisciplinary approach toscholarship and learning. As an employer Penn has been rankednationally on many occasions with the most recent award from Forbeswho named Penn one of America's Best Large Employers in 2023. Penn offers a unique working environment within the city ofPhiladelphia. The University is situated on a beautiful urbancampus, with easy access to a range of educational, cultural, andrecreational activities. With its historical significance andlandmarks, lively cultural offerings, and wide variety ofatmospheres, Philadelphia is the perfect place to call home forwork and play. The University offers a competitive benefits package that includesexcellent healthcare and tuition benefits for employees and theirfamilies, generous retirement benefits, a wide variety ofprofessional development opportunities, supportive work and familybenefits, a wealth of health and wellness programs and resources,and much more. Posted Job Title Clinical Research Regulatory Specialist B Job Profile Title Clinical Research Regulatory Specialist B Job Description Summary The Penn Neurogenetics Therapy Center (PNTC) supports a diversegroup of neurogenetics investigators and clinical researchprofessionals conducting investigator-initiated clinical researchand complex, industry-sponsored, first-in-human trials of genetherapies for neurological diseases. The PNTC is seeking a ClinicalResearch Regulatory Specialist B (CRRS B) to support clinical trialstartup and ongoing regulatory activities across the Center'sportfolio of clinical trials while following applicableinstitutional and federal regulations as well as ICH-GCPguidelines. The CRRS B will function as part of a multidisciplinaryteam and will report to the PNTC Director of Operations. Job Description The CRRS B will play a key role in coordinating trial start-upactivities from feasibility assessment through site activation,working closely with PNTC Project and Business Managers,investigators, study teams, institutional offices, sponsors, andcontract research organizations (CROs). Responsibilities willinclude coordinating and tracking regulatory and ancillarysubmissions, essential study documentation, and other startuprequirements to support efficient and timely study activation.Following activation, the CRRS B will collaborate with study teamsto provide ongoing regulatory support, including protocolamendments, continuing reviews, reportable events, regulatorydocumentation, maintenance of complete and inspection-ready studyfiles, and coordination of monitoring visits and audits. The ideal candidate will be highly motivated, organized, anddetail-oriented, with a proactive and collaborative approach andthe ability to plan and manage multiple priorities and deadlines ina fast-paced clinical research environment. Prior experience withregulatory/ethics boards/ancillary submissions and reviews,industry-sponsored early-phase clinical trials, and/or gene therapyresearch is strongly preferred. Coordinate clinical trial startup from feasibility assessmentthrough site activation, working collaboratively with PNTC Projectand Business Managers and other stakeholders to track regulatoryand ancillary submissions, essential study documentation,timelines, dependencies, outstanding items, and activationrequirements across regulatory, operational, budget, and contractworkflows. Prepare, coordinate, and process regulatory submissions to theIRB and required ancillary review committees, and prepare, collect,and submit essential regulatory documentation required by sponsors,CROs, and other applicable entities. Provide ongoing regulatory support for active clinical trials,including protocol amendments, continuing reviews, reportableevents, personnel and study document updates, and other requiredregulatory submissions and documentation. Maintain complete, accurate, current, and inspection-readyregulatory documentation and investigator site files (ISFs)throughout the study lifecycle in accordance with institutional,sponsor, and applicable regulatory requirements. Resolve regulatory queries and support study oversightactivities, including site initiation, monitoring, audit,inspection, and close-out activities, in collaboration withinvestigators and study teams. Participate in study team meetings, protocol and regulatorytraining, and compliance activities, and contribute to thedevelopment and continuous improvement of regulatory and clinicaltrial startup processes, guidance documents, templates, trackers,and other work tools. Perform additional duties as assigned. The position is hybrid eligible and contingent on continuedfunding. The job pay range encompasses the full range of employees from newhires to the salaries of Penn employees with many years ofexperience and seniority. It is not a precise indicator of the newsalaries of new hires when working at the top end. Qualifications Bachelor's degree and 3-5 years of research experience orequivalent combination of education and experience is required . Atleast 1 year of regulatory experience preferred. Associatedresearch credentialing (RAC, CCRP, CIP, etc.) preferred. Preferred: Must be organized and able to prioritize; effectivecommunication and writing skills; strong time management skills; flexible and able to multi-task; demonstrated ability to work aspart of a team, as well as independently. At least 1 year ofregulatory experience preferred. Associated research credentialing(RAC, CCRP, CIP, etc.) preferred. Job Location - City, State Philadelphia, Pennsylvania Department / School Perelman School of Medicine Pay Range $63,085.00 - $70,119.00 Annual Rate Salary offers are made based on the candidate's qualifications,experience, skills, and education as they directly relate to therequirements of the position, and in alignment with salary rangesbased on external market data for the job's level. Internalorganization and peer data at Penn are also considered. Equal Opportunity Statement The University of Pennsylvania is an equal opportunity employer.Candidates are considered for employment without regard to race,color, sex, sexual orientation, religion, creed, national origin(including shared ancestry or ethnic characteristics), citizenshipstatus, age, disability, veteran status or any class protectedunder applicable federal, state or local law. Special Requirements Background checks may be required after a conditional job offer ismade. Consideration of the background check will be tailored to therequirements of the job. University Benefits Health, Life, and Flexible Spending Accounts : Pennoffers comprehensive medical, prescription, behavioral health,dental, vision, and life insurance benefits to protect you and yourfamily's health and welfare. You can also use flexible spendingaccounts to pay for eligible health care and dependent careexpenses with pre-tax dollars. Tuition : Take advantage of Penn's exceptional tuitionbenefits. You, your spouse, and your dependent children can gettuition assistance here at Penn. Your dependent children are alsoeligible for tuition assistance at other institutions. Retirement: Penn offers generous retirement plans tohelp you save for your future. Penn's Basic, Matching, andSupplemental retirement plans allow you to save for retirement on apre-tax or Roth basis. Choose from a wide variety of investmentoptions through TIAA and Vanguard. Time Away from Work: Penn provides you with asubstantial amount of time away from work during the course of theyear. This allows you to relax, take vacations, attend to personalaffairs, recover from illness or injury, spend time withfamily-whatever your personal needs may be. Long-Term Care Insurance: In partnership with GenworthFinancial, Penn offers faculty and staff (and your eligible familymembers) long-term care insurance to help you cover some of thecosts of long-term care services received at home, in the communityor in a nursing facility. If you apply when you're newly hired, youwon't have to provide proof of good health or be subject tounderwriting requirements. Eligible family members must alwaysprovide proof of good health and are subject to underwriting. Wellness and Work-life Resources : Penn is committed tosupporting our faculty and staff as they balance the competingdemands of work and personal life. That's why we offer a widevariety of programs and resources to help you care for your health,your family, and your work-life balance. Professional and Personal Development: Penn provides anarray of resources to help you advance yourself personally andprofessionally. University Resources: As a member of the Penn community,you have access to a wide range of University resources as well ascultural and recreational activities. Take advantage of theUniversity's libraries and athletic facilities, or visit ourarboretum and art galleries. There's always something going on atPenn, whether it's a new exhibit at the Penn Museum, the latestmusic or theater presentation at the Annenberg Center, or the PennRelays at Franklin Field to name just a few examples. As a memberof the Penn community, you're right in the middle of theexcitement-and you and your family can enjoy many of theseactivities for free. Discounts and Special Services : From arts andentertainment to transportation and mortgages, you'll find greatdeals for University faculty and staff. Not only do Penn arts andcultural centers and museums offer free and discounted admissionand memberships to faculty and staff. You can also enjoysubstantial savings on other goods and services such as new carsfrom Ford and General Motors, cellular phone service plans, movietickets, and admission to theme parks. Flexible Work Hours: Flexible work options offercreative approaches for completing work while promoting balancebetween work and personal commitments. These approaches involve useof non-traditional work hours, locations, and/or jobstructures. Penn Home Ownership Services: Penn offers a forgivableloan for eligible employees interested in buying a home orcurrently residing in West Philadelphia, which can be used forclosing costs or home improvements. Adoption Assistance: Penn will reimburse eligibleemployees on qualified expenses in connection with the legaladoption of an eligible child, for upto two adoptions in your household. To learn more, please visit: #J-18808-Ljbffr University of Pennsylvania