Clinical Research Coordinator A/B

University of Pennsylvania • Philadelphia, PA

2d • $47,313 - $53,418 • 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. Position is contingent upon funding. This position is hybrid eligible after successful completion of 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 is required (for CRC A)
• Bachelor’s degree required and 2-3 years of related experience or equivalent combination of education and experience (for CRC B)
• Effective problem-solving abilities
• Effective communication and writing skills
• Strong organizational and time management skills
• 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 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
• 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
• Prepare and submit regulatory packages
• Correspond with sponsor & regulatory review boards
• Help with study start-up activities
• Use independent judgment in the management of assigned clinical trials
• Act in a lead capacity in coordination with CRU Research Team projects
• 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
• May be responsible for orientation/mentoring of new staff and act as resource to current staff members with study related issues

Benefits

• 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
• 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
• Retirement plans (Basic, Matching, and Supplemental) with pre-tax or Roth basis options
• Substantial amount of time away from work
• Long-term care insurance
• Wellness and work-life resources
• Professional and personal development resources
• Access to a wide range of University resources as well as cultural and recreational activities
• Discounts and special services (arts, entertainment, transportation, mortgages, new cars, cellular phone service, movie tickets, theme parks)
• Flexible work options
• Home ownership services (forgivable loan for eligible employees)
• Adoption assistance

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level