Clinical Research Coordinator A/B

Requirements

• Clinical Research Coordinator A
• Bachelor of Science and 1 to 2 years of experience or equivalent combination of education and experience is required. Regulatory experience is preferred; Radiation Oncology experience i

Benefits

Additional Information

University Overview The University of Pennsylvania, the largest private employer in Philadelphia, is a world-renowned leader in education, research, and innovation. This historic, Ivy League school consistently ranks among the top 10 universities in the annual U.S. News & World Report survey. Penn has 12 highly-regarded schools that provide opportunities for undergraduate, graduate and continuing education, all influenced by Penn's distinctive interdisciplinary approach to scholarship and learning. As an employer Penn has been ranked nationally on many occasions with the most recent award from Forbes who named Penn one of America's Best Large Employers in 2023. Penn offers a unique working environment within the city of Philadelphia. The University is situated on a beautiful urban campus, with easy access to a range of educational, cultural, and recreational activities. With its historical significance and landmarks, lively cultural offerings, and wide variety of atmospheres, Philadelphia is the perfect place to call home for work and play. The University offers a competitive benefits package that includes 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, and much more. Posted Job Title Clinical Research Coordinator A/B Job Profile Title Clinical Research Coordinator A Job Description Summary 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. Job Description Job Responsibilities Clinical Research Coordinator A 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 Clinical Research Coordinator B In addition to above, the CRC-B will 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. The CRC B will have less supervision from their project manager in the management of their assigned clinical trials and will need to use more independent judgment. 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. May be responsible for orientation/mentoring of new staff and act as resource to current staff members with study related issues. **Note that the CRC A works under direct supervision from their manager while the CRC B works under limited supervision.**

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