Note: The job is a remote job and is open to candidates in USA. The University of Pennsylvania is a prestigious institution known for its leadership in education and research. They are seeking a Clinical Research Coordinator B/C to manage clinical trials in the Radiation Oncology department, ensuring compliance with protocols and regulatory standards while supporting patient enrollment and data management.
Responsibilities
- Coordinate trial related activities to ensure the execution of the trials adheres 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
- Communicate with potential patients, pre-screening, scheduling, consenting, and enrolling patients; ensuring all the enrolled subjects have documented eligibility check list and signed appropriate version of consent
- Coordinate research visits; maintaining source documentation, data collection and completing CRFs; obtaining, handling, processing, transferring /shipping of biospecimens when applicable
- Track 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
- Perform 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
- 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
Skills
- 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
- Flexibility and ability to manage multiple tasks while maintaining strong attention to detail
- Capability of working both independently and as part of a team
- Knowledge of IRB and human research protection regulations
- Regulatory experience is preferred
- Radiation Oncology experience is preferred but not required
Benefits
- Comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits to protect you and your family’s health and welfare
- Flexible spending accounts to pay for eligible health care and dependent care expenses with pre-tax dollars
- Tuition assistance here at Penn for you, your spouse, and your dependent children
- Tuition assistance at other institutions for your dependent children
- 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
- Wide variety of investment options through TIAA and Vanguard
- Substantial amount of time away from work during the course of the year
- 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
- Long-term care insurance available without proof of good health or underwriting requirements if applied when newly hired
- Wellness and work-life resources
- Array of resources to help you advance yourself personally and professionally
- Access to a wide range of University resources as well as cultural and recreational activities
- Free and discounted admission and memberships to faculty and staff at Penn arts and cultural centers and museums
- Substantial savings on 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 options involving use of 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, which can be used for closing costs or home improvements
- Reimbursement for 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
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