Clinical Research Nurse Manager (Department of Gastroenterology)

University OverviewThe University of Pennsylvania, the largest private employer in Philadelphia, is a world-renowned leader in education, research, and innovation.

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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 TitleClinical Research Nurse Manager (Department of Gastroenterology)Job Profile TitleClinical Research Nurse DJob Description SummaryThe Division of Gastroenterology Research Team at the University of Pennsylvania is seeking a dedicated full-time Clinical Research Nurse Manager.

In this role, you will support the Associate Director and Physician leaders in overseeing and managing a diverse clinical research portfolio.

Key responsibilities include coordinating the execution of clinical trials, ensuring compliance with institutional and regulatory requirements, and managing the full lifecycle of study activities.

Additionally, you will provide leadership and oversight to clinical trials and research personnel, which includes training clinical staff, contributing to the development of protocols and study policies, and ensuring effective communication with principal investigators.

The role requires the ability to manage multiple studies simultaneously, ensuring high standards of research integrity and patient care.

This individual will work independently with minimal supervision.Job DescriptionJob ResponsibilitiesSUPERVISORY RESPONSIBILITIESDetermine workload and assignments for Clinical Research Coordinators (CRCs) and other support staff.

Responsible for or participate in the hiring and performance management of the CRCs and other support staff.Actively work towards process improvement including assisting in the development of SOPs.

Meet with Principal Investigator(s) routinely to discuss study portfoliosCLINICAL RESEARCH NURSING RESPONSIBILITIES : Coordinate the conduct of Phase I IV clinical trials.

Coordinate the administration of the investigational product and study-related medicationsParticipate in the determination of protocol feasibility.

Participate in the conduct of audits by study sponsors, CROs, the FDA, and other entities as required.Participate in the development of protocol case report forms and progress notesConduct initiation, monitoring, and closeout visits with sponsors and / or CROs.

Recruit and screen potential study patients as specified per protocol.Oversee the processing and shipping of blood, urine, and serum specimens for each trialOversee the obtaining of records required to complete case report forms.

Show vigilance in patient safety, protocol compliance, and data quality.Ability to operationalize a clinical research protocolREGULATORY RESPONSIBILITIESPrepare and process all IRB documentation , including submissions,continuing reviews, amendments, and adverse event reporting.

Prepare and process all regulatory documentation with pharmaceuticalcompanies and CROs.Organize and maintain all documentation required by the sponsor orCRO (institutional forms, FDA Form 1572, deviation memos, physiciansand coordinators CVs and medical licenses).

Resolve regulatory-related queries with IRB, study sponsors, and CROs.Adhere to all University of Pennsylvania, FDA, and ICH guidelinesQualificationsRegistered Nurse;

licensure in Commonwealth of PA without restriction or limitation and 4 to 5 years of experience; BSN preferred, or equivalent combination of education and experience is required.

Position is contingent upon continued funding.Job Location - City, StatePhiladelphia, PennsylvaniaDepartment / SchoolPerelman School of MedicinePay Range$61,046.

00 - $101,000.00 Annual RateSalary 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 BenefitsHealth, 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 : The University of Pennsylvania's special character is reflected in the diversity of the Penn community.

We seek talented faculty and staff who will constitute a vibrant community that draws on the strength that comes with a substantive institutional commitment to diversity along dimensions of race, ethnicity, gender, sexual orientation, age, religion, disability, veteran status, interests, perspectives, and socioeconomic status.

Grounded in equal opportunity, nondiscrimination, and affirmative action, Penn's robust commitment to diversity is fundamental to the University's mission of advancing knowledge, educating leaders for all sectors of society, and public service.

The University of Pennsylvania prohibits unlawful discrimination based on 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.