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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 C/D
Job Profile Title
Clinical Research Nurse D
Job Description Summary
The Perelman School of Medicine at the University of Pennsylvania is the oldest and one of the finest medical schools in the United States. Penn is rich in tradition and heritage and at the same time consistently at the forefront of new developments and innovations in medical education and research. Since its founding in 1765 the School has been a strong presence in the community and prides itself on educating the leaders of tomorrow in patient care, biomedical research, and medical education. http://www.med.upenn.edu/
Clinical Research Nurse C: Independently coordinate the conduct of Phase I â“ IV clinical trials including consenting, screening and enrolling eligible subjects, managing subject treatment per protocol, oversight and coordination of research testing, including labs, office visits and radiology exams, provide oversight for research medication administration and blood draws.Â Monitor patient care, treatment side effects and patient status throughout study period, communicate any research issues to PI and primary MD, communication with research team, including Investigators, CRC and regulatory team, to ensure patient safety and proper study conduct, provide patient/family education and support, follow GCP guidelines in the conduct of trials, coordinate implementation of research protocols with study and clinical team, collecting and reporting research data, creation of study materials/worksheets, Beacon plan, reporting serious adverse events per protocol, coordinate subject care with clinical team, provide coverage and support to other research nurses and coordinators, maintain good communication with supervisors, co-workers and study team, possibly assist in the writing and development of investigator-initiated protocols, participate in the development of unit SOPâ™s, serve as a resource for junior staff, serve as a resource for development of study orders, provide input into the development of efficient work flows, attend study related meetings that may occur outside of usual work ours, other duties as assigned.
Qualifications: Clinical Research Nurse C:Â Registered Nurse with license to practice in the State of Pennsylvania, 2-3 years of nursing experience and at least 2 years of clinical research experience is preferred. BS degree in Nursing or a Bachelor degree in a related discipline required.Â Oncology experience (either nursing or clinical research) is highly preferred. Effective problem solving abilities; effective communication and writing skills; strong organizational skills; flexible and able to multi-task; demonstrated abilityÂ to work as part of a team, as well as independently; knowledge of IRB and human research protection regulations. Â
Clinical Research Nurse D: Coordinate all aspects of Phase I â“ IV oncology clinical trials for patients, including coordination.Â Work closely with the Investigators to select appropriate studies and maximize enrollment.Â Review of protocols during approval process to ensure necessary resources are in place, complete logistical review forms.Â Work with clinical staff, including, but not limited to lab, infusion, radiology, Advanced Practitioners, triage, inpatient and pharmacy to educate/train regarding protocol requirements and study agents, ensuring protocol compliance and maximize efficient implementation of the protocol while serving as a resource.Â Develop and Maintain ongoing communication with the clinical teams.Â Develop and Lead working groups within the CRU that will maximize the efficiency and quality of research performed within the program, including developing SOPâ™s.Â Coordination of trial activities will include, but is not limited to, obtaining informed consent, screening and enrollment of study participants, confirming eligibility and registration of subjects, scheduling study related visits (e.g., lab tests and procedures), coordinate administration of medications and treatments, study drugs and interventions, including injections; blood drawing, including blood draws via venipuncture and through accessingÂ lines and ports, conduct study and subject assessments; monitor patient care, assess patient status, monitor treatment side effects, non-serious and serious adverse event reporting; assure protocol compliance; collect data and maintain source data documentation, creation of study materials/worksheets, Beacon orders, ensuring completion of source documents and case report forms (CRFs), resolve queries, conduct initiation, monitoring audit and closeout visits with sponsors. Coordination may also include, but often to a lesser degree, the submission of study documents to all applicable institutional committees (e.g., IRB, CTSRMC, IBC, CTRC) for initial approval, continuing reviews and for approval of any amendments, maintenance of regulatory files, preparation for monitoring visits and audits, and assisting Sponsor with annual IND reporting. Â
Qualifications: Clinical Research Nurse D: Registered Nurse with license to practice in the State of Pennsylvania, 4 -5 years of nursing experience and at least 3 years of clinical research experience is preferred. BS degree in Nursing or a Bachelor degree in a related discipline required.Â Oncology experience (either nursing or clinical research) is highly preferred. Effective problem solving abilities; effective communication and writing skills; strong organizational skills; flexible and able to multi-task; demonstrated abilityÂ to work as part of a team, as well as independently; knowledge of IRB and human research protection regulations. Â
Possess working knowledge of the Title 21 Code of Federal Regulations (CFR), International Conference of Harmonisation (ICH) and Good Clinical (Research) Practice (GCP) Guidelines. Â
Possess strong computer skills and working knowledge of Microsoft Office tools (e.g., Word, Excel, PowerPoint).
POSITION IS CONTINGENT UPON FUNDING
Job Location - City, State
Department / School
Perelman School of Medicine
$59,703.00 - $113,435.00
Affirmative Action Statement Penn adheres to a policy that prohibits discrimination on the basis of race, color, sex, sexual orientation, gender identity, religion, creed, national or ethnic origin, citizenship status, age, disability, veteran status, or any other legally protected class.
Special Requirements Background check required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.
Internal Number: JR00014765
About University of Pennsylvania
Penn has a long and proud tradition of intellectual rigor and pursuit of innovative knowledge, begun by Benjamin Franklin in 1740. That tradition lives today through the creativity, entrepreneurship, and engagement of our faculty, students, and staff. Academic life at Penn is unparalleled, with an undergraduate student body of 10,000 from every U.S. state and around the world. The entering class of 2015 is the most talented and diverse in Penn's history. Consistently ranked among the top 10 universities in the country, Penn welcomes an additional 10,000 students to our top-ranked graduate and professional schools.