Clinical Research Nurse B

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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 Nurse B Job Profile Title Clinical Research Nurse B Job Description Summary Responsible for implementing clinical research activities within the Cardiovascular Division of PPMC. The clinical research nurse will participate in clinical studies in interventional and vascular cardiology. Coordinates investigational protocols under the supervision of Administrative Director and Principal Investigator. Major responsibilities include but not limited to obtaining detailed knowledge of all components of trial protocols, screening and enrolling patients, conducting follow-up activities, performing phlebotomy to collect samples from patients, abstracting medical and demographics data from medical records, completing source documents and case report forms, data entry using various electronic data collection system, managing the adverse event reporting process and assisting with the regulatory and financial management of multiple studies. Coordinate several investigational device trials in the cath lab, instruct and support investigators and study staff on carrying out clinical protocol and other study related requirements Job Description This position is contingent upon favorable funding. Job Responsibilities Assist in research studies using approved protocols, according to GCP. Familiarize with all components of study protocols by review of study, related literature prior to start. Attend Investigators Meetings. Assure accurate, completion and updates of the Delegation of Duties and Authorized Signatures Form. Confer with the pharmacist as needed to assure the availability of study drug. Create, maintain research data, regulatory files. Timely initiation of screening, enrolling patients. Screen to identify potential patients for specific studies, determine patient eligibility by communicating with physicians, clinical staff and by reviewing medical records to validate potential patient data against Inclusion /Exclusion checklists. Recruit patients, explain protocol, consent forms. Assure original signed consents are maintained in the study binder. Complete screening/enrollment logs and submit to sponsor, as protocol. Schedule and conduct follow-up visits with patients and assure research team availability to assure all follow-up activities are conducted within sponsor designated time frames including documentation of follow-up efforts. Schedule additional protocol-required tests/procedures. Create and maintain a complete and accurate regulatory binder for each study. Prepare and process all regulatory documentation with research sponsors and clinical research organizations (CROs). Obtain the appropriate signatures for regulatory forms. Perform Phlebotomy to collect blood samples of study patients. Centrifuge blood specimens and separate into transfer vials according to sponsor specifications. Ship blood and urine specimens to study-specific central labs according to Transportation of Dangerous Goods regulations. Complete all source documents and worksheets within 48 hours of study activity. Complete and/or enter all clinical record forms (CRFs) within 5 working days or less depending on sponsor requirements. Create and maintain subject binders. Obtain records required to complete CRFs. Assure inclusion of enrollment information, research orders, and other communications are entered into the electronic medical record of each subject. Resolve data queries with sponsors/CROs. Monitor adherence to protocol throughout enrollment in study. Notify Pl, RPM, and sponsor of any deviations from protocol or adverse even

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