Clinical Research Coordinator B/C

University of Pennsylvania•Philadelphia, PA

3d•Hybrid

About The Position

The Clinical Research Coordinator B/C in the department of Radiation Oncology coordinates investigator-initiated and sponsored clinical trials involving radiation therapy; ensuring strict adherence to study protocols; regulatory requirements, and radiation safety standards. This role supports patient enrollment, scheduling and follow-up, data collection, and regulatory documentation while collaborating closely with the CRU team. Position is contingent on continued funding. This position is hybrid eligible after successful completion of intro period and 6 months of service.

Requirements

Clinical Research Coordinator B
Bachelor of Science and 2 to 3 years of experience or equivalent combination of education and experience is required.
Clinical Research Coordinator C
Bachelor’s degree required and 4-6 years of related experience (or equivalent combination of education and experience).
The successful candidate must have:
effective problem-solving abilities
effective communication and writing skills
strong organizational and time management skills
be flexible and able to multi-task
strong attention to detail
ability to work as part of a team, as well as independently
knowledge of IRB and human research protection regulations
demonstrates high reliability and a good work ethic
Position is contingent on continued funding.
This position is hybrid eligible after successful completion of intro period and 6 months of service.

Nice To Haves

Regulatory experience is preferred
Radiation Oncology experience is preferred but not required.

Responsibilities

Coordinating trial related activities to ensure the execution of the trials is adherence to the protocol and regulatory compliance
Maintaining regulatory documents per sponsor requirements, University of Pennsylvania, FDA, and GCP standards and guidelines
Preparing and participating study monitoring and audit visits
Communicating with potential patients, Pre-screening, scheduling, consenting, and enrolling patients
Making sure all the enrolled subjects have documented eligibility check list and signed appropriate version of consent
Coordinating research visits
Maintaining source documentation, Data collection and Completing CRFs
Obtaining, handling, processing, transferring /shipping of biospecimens when applicable
Tracking AE/SAE, maintaining documentation, and study logs
Coordinating with regulatory specialist when regulatory entities report is needed, such as reportable AE/SAE, Deviations
Conduct follow up phone calls to participants; includes tracking participants through the timepoints
Uploading data to relevant databases
Perform data QC and address queries
Performing research billing review, subject reimbursement when applicable
Documenting all trainings and essential correspondence that related to study.
Attending study related meetings and other meetings as required, Maintaining/ordering study materials as needed
Adhere to all University of Pennsylvania, ICF, and FDA guidelines.
Other duties and responsibilities as assigned
In addition to the above, the CRC C will will work with minimal supervision from their project manager and independently manage their assigned clinical trials.
The CRC-C may act in a lead capacity in coordination with CRU Research Team projects and assist Research Team Managers in overseeing the execution of project timelines as well as completion of study related activities delegated to the research coordinators(A/B) who provide study related support.
May be responsible for orientation/mentoring of new staff and act as resource to current staff members with study related issues.

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.