Clinical Research Nurse C

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Posted Job Title

Clinical Research Nurse C

Job Profile Title

Clinical Research Nurse C

Job Description Summary

The Clinical Research Nurse will report directly to the Director of RadOnc CRU. Supporting all aspects of clinical research activities in the RadOnc CRU that requires a RN involvement. Independently coordinates complex clinical trials, including subject consent, screening, enrollment, treatment management, & follow-up. In charge of Beacon built/order, AE/SAE assessments. May administer medications & contribute to protocol development & SOPs of IITs. Serves as a resource to junior staff, participates in working groups, & provides input on workflow, enrollent strategies, budgets, & regulatory compliance. BSN degree with 2-3 years, or equivalent combination of education and experience.

Job Description

Job Responsibilities

• Work in collaboration with Research Team Leaders and Principal Investigators with initiating study procedures for new IITs and industry-sponsored clinical trials. Manage all aspects of clinical studies and all Phases of clinical trials. Participate in the conduct of audits by study sponsors, CROs, the FDA, the University of Pennsylvania’s CTSRMC, and other groups.

• Coordinate the conduct of Phase I - IV clinical trials including consenting, screening and enrolling eligible subjects, follow GCP guidelines in the conduct of trials, coordinate implementation of research protocols with study and clinical team, collecting and reporting research data, accessing and reporting  AE/SAEs per protocol, managing subject treatment per protocol, oversight and coordination of research testing, including labs, office visits and radiology exams, coordinate subject care with clinical team, provide coverage and support to research coordinators.

• Care for study participants in all age groups from children through geriatrics. Establishes nursing plan of care in collaboration with the PI and study team and in accordance with research guidelines and GCP. Creation of beacon built/orders and nursing worksheets as needed during study start-up. Administer or provide oversight of administration of medications.

• Participate in study team, disease-site group and ongoing protocol training/compliance meetings. If needed, collect, review and report timely, valid, accurate study data within the timelines specified by protocol or CTA. Coordination may also include clinical activities such as performing and collecting vital signs, EKG, etc.

• Coordinate projects and assist managers in overseeing execution of project timelines as well as completion of study related activities, contribute to protocol development, SOPs of IITs. Serves as a resource to junior staff, participates in working groups, & provides input on workflow, enrollment strategies, budgets, & regulatory complian