Clinical Research Coordinator A/B

University of Pennsylvania Perelman School of Medicine•Philadelphia, PA

16h•Hybrid

About The Position

The Clinical Research Coordinator A/B 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. The Clinical Research Coordinator A works under direct supervision from their manager, while the Clinical Research Coordinator B works under limited supervision. The CRC B will also develop study specific source documents and trackers, prepare and submit regulatory packages, correspond with sponsor & regulatory review boards, and help with study start-up activities. They 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) who provide study related support. The CRC B may also be responsible for orientation/mentoring of new staff and act as a resource to current staff members with study related issues. This position is contingent upon funding and is hybrid eligible after successful completion of an intro period and 6 months of service.

Requirements

Bachelor of Science and 1 to 2 years of experience or equivalent combination of education and experience (for Clinical Research Coordinator A)
Bachelor’s degree and 2-3 years of related experience or equivalent combination of education and experience (for Clinical Research Coordinator B)
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

Nice To Haves

Regulatory experience
Radiation Oncology experience

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
Promote good clinical practice in the conduct of clinical investigations, included possessing an in-depth knowledge of the federal regulations and guidance documents for the conduct of clinical studies and human subject protection
Other duties and responsibilities as assigned
Develop study specific source documents and trackers (CRC B)
Prepare and submit regulatory packages (CRC B)
Correspond with sponsor & regulatory review boards (CRC B)
Help with study start-up activities (CRC B)
Act in a lead capacity in coordination with CRU Research Team projects (CRC B)
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) who provide study related support (CRC B)
May be responsible for orientation/mentoring of new staff and act as resource to current staff members with study related issues (CRC B)

Benefits

Comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits
Flexible spending accounts to pay for eligible health care and dependent care expenses with pre-tax dollars
Tuition assistance for employees, spouses, and dependent children at Penn
Tuition assistance for dependent children at other institutions
Generous retirement plans (Basic, Matching, and Supplemental) to save for your future on a pre-tax or Roth basis, with investment options through TIAA and Vanguard
Substantial amount of time away from work for relaxation, vacations, personal affairs, recovery from illness or injury, and family time
Long-term care insurance (in partnership with Genworth Financial) for faculty and staff (and eligible family members)
Wide variety of programs and resources to help balance work and personal life (Wellness and Work-life Resources)
Array of resources for professional and personal development
Access to a wide range of University resources (libraries, athletic facilities, arboretum, art galleries, Penn Museum, Annenberg Center, Penn Relays)
Discounts and Special Services on goods and services such as new cars, cellular phone service plans, movie tickets, and admission to theme parks, as well as free/discounted admission/memberships to Penn arts and cultural centers and museums
Flexible work options involving non-traditional work hours, locations, and/or job structures
Forgivable loan for eligible employees interested in buying a home or currently residing in West Philadelphia (Penn Home Ownership Services)
Reimbursement for 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 (Adoption Assistance)