Job Description

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 Researcher Coordinator B/C

Job Profile Title

Clinical Research Coordinator B

Job Description Summary

As part of the Infectious Disease Clinical Trials Group, this position will coordinate clinical research consisting of projects in HIV

and other infectious diseases. The person will support Infectious Disease Investigators in clinical research ranging from

observational trials to investigational product trials, including both investigator-initiated and industry-initiated trials. Prior

experience in gene therapy clinical trials is ideal but not required. Work requires on-site presence and interaction with research subjects.

Research coordinator work includes study implementation, document development, submission to regulatory boards, subject

recruitment and enrollment, study visits, and regulatory compliance in one or more studies.

Job Description

Job Responsibilities

Screen, recruit, and enroll consenting patients using Good Clinical Practice guidelines and conduct compliance monitoring of study participants across infectious disease and gene therapy protocols.

Coordinator B: Participate in and coordinate clinical trials within the Penn Division of Infectious Disease Clinical Trials Unit, consisting of projects in HIV and other Infectious Diseases. The person will support Infectious Disease Investigators in

clinical research ranging from observational trials to investigational product trials, including both investigator-initiated and industry-initiated trials. Work requires on-site presence and interaction with research subjects. Coordinator duties include:

Assist in development of study documents. Communicate with study team members and regulatory review boards. Recruit, consent, and screen patients according to protocol (including specialized gene therapy protocols). Schedule patient visits

and any necessary testing. Conduct patient visits. Monitor patients per protocol requirements and ensure adherence to protocol requirements. Organize and maintain all documentation required by the Investigator, sponsor, or CRO, including

source documentation, case report forms, and research charts. Collect, review, and report study data. Complete case report forms and resolve data queries. Process and ship study specimens including blood and urine. Participate in initiation, monitoring, audit, and close-out visits. Participate in study team meetings and ongoing protocol training. 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 all University of Pennsylvania, FDA, and GCP guidelines.

Coordinator C: The Clinical Research Coordinator C is expected to perform the duties above with more limited supervision from the program manager. In addition, will develop complex documents such as protocols and consents (specifically

incorporating gene therapy workflows and endpoints), lead team meetings, and may take a lead role in study communication with internal and external groups. Work directly with investigators to design, set-up, and execute studies.

Accountable for making sure study timelines and goals are met. Independently move a clinical trial through each phase of development, resolving issues and queries with input from a supervisor as required. Management of clinical trials with a higher degree of independent judgment

Conduct study-related visits, including procedures such as blood draws, vitals, medical history, ECGs, specialized gene therapy protocol administration/monitoring, and processing of biological specimens; manage study data and regulatory files per GCP.

Prepare for audits, review regulatory binders, perform internal audit and other QA activities, and handle monitor/audit visits with CROs, the FDA, and other entities.

Correspond regularly with the Institutional Review Board and other regulatory agencies (including IBC/gene therapy oversight bodies as applicable), including preparation and submission of protocols, protocol amendments, SAE reports, and DSMB subject narratives.

Coordinator B: With supervision, assist in preparation of research protocols and documents.

Coordinator C: Work with primary investigators to develop investigator-initiated protocols, case report forms, and databases. Independently design research documents including consent forms, source documents, CRFs, and training SOPs for complex trials (including gene therapy).

Coordinator B: With the help of the program manager, manage/coordinate/organize the daily work of research assistants for tasks such as recruitment, study visits, and regulatory, and train them in these tasks. Attend Investigator Meetings and communicate meeting information to the study team.

Coordinator C: A CRC C will be expected to do this independently.

Perform additional duties as assigned.

Position contingent on funding.

Qualifications

Effective problem-solving abilities; effective communication and writing skills; strong organizational and time management skills; flexible and able to multi-task; strong attention to detail; demonstrated ability to work as part of a team, as well as independently; knowledge of IRB and human research protection regulations; highly reliable and good work ethic required. Recent experience with phlebotomy preferred.

• Coordinator B: Bachelor’s degree required and 2–4 years of related clinical research experience (or equivalent combination of education and experience).
• Coordinator C: Bachelor’s degree required and 4+ years of related clinical research experience (or equivalent combination of education and experience)

Job Location - City, State

Philadelphia, Pennsylvania

Department / School

Perelman School of Medicine

Pay Range

$53,418.00 - $63,085.00 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.

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To learn more, please visit: https://www.hr.upenn.edu/PennHR/benefits-pay