Clinical Research Coordinator B/C

University of Pennsylvania Perelman School of Medicine•Philadelphia, PA

22h•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 intro 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. The CRC-C 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 CRC B)
Bachelor’s degree and 4 to 6 years of experience or equivalent combination of education and experience is required (for CRC 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 is preferred
Radiation Oncology experience is preferred but not required

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 (CRC C)
Act in a lead capacity in coordination with CRU Research Team projects (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 (CRC C)
Be responsible for orientation/mentoring of new staff (CRC C)
Act as resource to current staff members with study related issues (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, 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, cultural and recreational activities (libraries, athletic facilities, arboretum, art galleries, Penn Museum, Annenberg Center, Penn Relays)
Discounts and Special Services on arts and entertainment, transportation, mortgages, new cars from Ford and General Motors, cellular phone service plans, movie tickets, and admission to theme parks
Flexible work options involving use of non-traditional work hours, locations, and/or job structures
Penn Home Ownership Services: 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: reimbursement for qualified expenses in connection with the legal adoption of an eligible child, for up to two adoptions