Clinical Research Coordinator B/C

University of Pennsylvania•Philadelphia, PA

1d•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. The position is contingent on continued funding and is hybrid eligible after successful completion of an introductory period and 6 months of service. The Clinical Research Coordinator C 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. They may also be responsible for orientation/mentoring of new staff and act as a resource to current staff members with study related issues.

Requirements

Bachelor of Science and 2 to 3 years of experience or equivalent combination of education and experience is required (for Clinical Research Coordinator B)
Bachelor’s degree and 4 to 6 years of experience or equivalent combination of education and experience is required (for Clinical Research Coordinator C)
Strong problem-solving abilities
Excellent written and verbal communication skills
Solid organizational and time management skills
Flexible and able to manage multiple tasks while maintaining strong attention to detail
Capable of working both independently and as part of a team
Knowledge of IRB and human research protection regulations

Nice To Haves

Regulatory experience
Radiation Oncology experience

Responsibilities

Coordinate trial related activities to ensure the execution of the trials adheres to the protocol and regulatory compliance
Maintain regulatory documents per sponsor requirements, University of Pennsylvania, FDA, and GCP standards and guidelines
Prepare and participate in study monitoring and audit visits
Communicate with potential patients, pre-screening, scheduling, consenting, and enrolling patients
Ensure all the enrolled subjects have documented eligibility check list and signed appropriate version of consent
Coordinate research visits
Maintain source documentation, data collection and completing CRFs
Obtain, handle, process, transfer /shipping of biospecimens when applicable
Track AE/SAE, maintaining documentation, and study logs
Coordinate with regulatory specialist when regulatory entities report is needed, such as reportable AE/SAE deviations
Conduct follow up phone calls to participants
Track participants through the timepoints, uploading data to relevant databases
Perform data QC and address queries
Perform research billing review, subject reimbursement when applicable
Document all trainings and essential correspondence that related to study
Attend study related meetings and other meetings as required
Maintain/order study materials as needed
Adhere to all University of Pennsylvania, ICF, and FDA guidelines
Work with minimal supervision from their project manager and independently manage their assigned clinical trials (for CRC C)
Act in a lead capacity in coordination with CRU Research Team projects (for CRC C)
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 (for CRC C)
May be responsible for orientation/mentoring of new staff (for CRC C)
Act as resource to current staff members with study related issues (for CRC C)

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, your spouse, and your dependent children at Penn
Tuition assistance for dependent children at other institutions
Generous retirement plans (Basic, Matching, and Supplemental) to help you save for your future on a pre-tax or Roth basis
Wide variety of investment options through TIAA and Vanguard
Substantial amount of time away from work (vacations, personal affairs, illness or injury, family time)
Long-Term Care Insurance in partnership with Genworth Financial
Wide variety of programs and resources to help you care for your health, your family, and your work-life balance (Wellness and Work-life Resources)
Array of resources to help you advance yourself personally and professionally (Professional and Personal Development)
Access to a wide range of University resources (libraries, athletic facilities, arboretum, art galleries) as well as cultural and recreational activities
Free and discounted admission and memberships to Penn arts and cultural centers and museums
Substantial savings on other goods and services such as new cars, cellular phone service plans, movie tickets, and admission to theme parks
Flexible work options for completing work while promoting balance between work and personal commitments (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 (Adoption Assistance)