Job Details

Clinical Research Program Manager C (Department of Cardiovascular Medicine)

Position Number: 6125332
Location: Philadelphia, PA
Position Type: Medicine - Medical Researcher

Clinical Research Program Manager C (Department of Cardiovascular Medicine)

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
Clinical Research Program Manager C (Department of Cardiovascular Medicine)

Job Profile Title
Clinical Research Program Manager C

Job Description Summary
The Clinical Research Program Lead C position will directly report to the Associate Director of the CCRU. The
successful candidate will support all aspects of the clinical research portfolio being performed for their research
program(s). He/she will support the start-to-end processes for study start-up and ongoing study management and day-to-
day functional coverage for clinical research coordinators. This includes study feasibility and selection, prioritization of the team's work, working closely with the Associate Director and Principal Investigators, review and initiate trials to ensure competitive activation and enrollment timelines. The Clinical Research Program Lead C is expected to actively manage ongoing research projects, troubleshoot operational issues daily and assist with all aspects of trial activities during absences or when a specific team member's workload exceeds capacity (including, but not limited to, managing the research team protocol portfolio including budget trackers, patient visits, transporting specimens, data entry, query resolution and working with study monitors).

The Clinical Research Program Lead C will be a liaison between major internal and external (sponsors, facilities,
CROs, Subcontractors, Collaborators) stakeholders, to develop project plans and support day to day operations of clinical
research proposals. The Clinical Research Program Lead C will work with Investigators and data informatics
teams/programs to ensure the Cardiovascular Clinical Research Program is supporting the patient population they are
studying.

The Clinical Research Program Lead C will manage Phase I-IV clinical trials and investigator initiated studies. Additional activities may include recruitment, and enrollment of patients according to protocol requirements for their team. He/she may schedule patient visits and any necessary testing, monitor patients per protocol requirements and ensure adherence to protocol requirements, organize, and maintain all documentation required by the sponsor or CRO- includes source documentation, case report forms, and research charts. He/she may collect, review and report study data, complete case report forms and resolve data queries, process and ship study
specimens including blood, urine, and tissue samples, participate in initiation, monitoring, audit and close-out visits,
coordinate study team meetings, disease site and/or discipline group meetings, and ongoing protocol training/compliance meetings. The Clinical Research Program Lead C will assist in the development/maintenance of study specific case report forms and source document tools, show vigilance in patient safety, protocol compliance and data quality. Adhere to the requirements of the University of Pennsylvania, GCP, FDA and all applicable regulatory bodies.

Job Description

Job Responsibilities

Indirect supervision of clinical research coordinator(s), and research assistants. This may include conducting weekly or every other week meetings with team members to review the status of their studies in detail, items that are outstanding, and troubleshooting issues needing to be addressed.
Work with the CCRU AD and Medical Director to ensure balanced staff workload, optimize study portfolio for currently available resources, anticipate any need for the research team to hire additional staff based on data analysis, maintain the overall staff assignments and workload for their group, identifying any needs or areas of under-utilization
Facilitate the initiation of new trials from feasibility review, new study submission, through activation, including tracking of protocols, contracts, and budgets through the start-up process, working with sponsor to schedule SIV's, and maintain communication with study teams and collaborative UPHS departments regarding progress
Perform group-specific regulatory activities, such as site selection visits, document completion (siteselection questionnaires, 1572's and financial disclosure forms), and IRB and IND report completion

(with investigator input), including AE reports, deviations, CRs and modifications
Work closely with the Regulatory Coordinator, provide Regulatory Support for study team protocols by submit complete Initial or Amendment study packets, performing site selection visits, regulatory document completion
Work with team members to ensure accurate and timely data entry into electronic Clinical Trials Management System, including study status, screening logs, serious adverse events, and subject enrollment status. The Program Manager may also have primary study coordinator responsibility for at least 1 study.
Responsible for:
Review of program metrics (performance, portfolio, enrollment)
Timely communication of significant challenges encountered by the team
Participate in leader meetings and serve on subject matter expert work groups as needed to enhance overall workflow efficiencies and quality of research
The candidate will develop and implement SOP's
Perform additional duties as assigned.

Qualifications

Bachelor's degree and 7-10 years of related experience or equivalent combination of education and experience is required. Master's degree and 5-7 years of experience preferred.

Position is contingent upon continued funding.

Job Location - City, State
Philadelphia, Pennsylvania

Department / School
Perelman School of Medicine

Pay Range
$89,500.00 - $130,000.00 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, and in alignment with salary ranges based on external market data for the job's level. Internal organization 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), citizenship status, age, disability, veteran status or any class protected under applicable federal, state or local law.

Special Requirements
Background checks may be 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

Equal Employment 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), citizenship status, age, disability, veteran status or any class protected under applicable federal, state, or local law.
To apply, visit https://wd1.myworkdaysite.com/en-US/recruiting/upenn/careers-at-penn/job/Smilow-Center-for-Translational/Clinical-Research-Program-Manager-C--Department-of-Cardiovascular-Medicine-_JR00104902-1