Posted in Other 4 days ago.
Location: Philadelphia, Pennsylvania
Clinical Research Nurse C
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 C
Job Profile Title
Clinical Research Nurse C
Job Description Summary
Clinical Research Nursing is the specialized practice of professional nursing focused on maintaining equilibrium between care of the research participant and fidelity to the research protocol. This specialty practice incorporates human subject protection; care coordination and continuity; contribution to clinical science; clinical practice; and study management throughout a variety of professional roles, practice settings, and clinical specialties. Principle duties include coordination and implementation of Phase I- IV clinical trials, coordination and continuity of care for patients enrolled in clinical trials, collaboration among multiple stakeholders involved in the implementation of clinical trials for which they are assigned, and adherence to all applicable guidelines, policies, and procedures related to clinical care and its intersection with the clinical research protocol. The CRN- C has additional responsibilities in the following domains: contribution to clinical science, technology/ informatics, leadership.
The Penn Prevention Research Division is a multidisciplinary team conducting a variety of clinical trials of investigational products designed to prevent infectious diseases. We have a primary focus on prevention of HIV infection through vaccine and novel pre-exposure prophylaxis agents, however we conduct other vaccine research as well. We are a fast paced, high volume, highly performing unit with a commitment to collaborative work.
Job Description
Job Responsibilities:
Human Subjects Protection
Elicit the research participant's values preferences, expressed needs, knowledge of the healthcare situation, understanding of research protocol requirements, and acceptance of risks versus benefits
Apply ethical, legal, and privacy guidelines and policies
to the collection, maintenance, use, and dissemination of data and information.
Facilitate initial and ongoing informed consent process
Care Coordination and Continuity
Coordinate research participant study visits
Facilitate research participant inquiries and concerns
Facilitate education of the interdisciplinary team on study requirements
Collaborate with interdisciplinary team to create a plan of care that allows for safe and effective collection of clinical research data
Provide nursing leadership within the interdisciplinary team
Coordinate interdisciplinary meetings and activities in the context of ta study
Coordinate referrals to appropriate interdisciplinary services outside the immediate research team
Communicate the impact of study procedures on the research participants
Provide nursing expertise to community based health care personnel related to study participation
Contribution to Clinical Science
Ability to review protocol for potential enrollment/ retention issues that may occur regarding logistics of the care delivery system and make recommendations to reduce disruption to protocol compliance and safe patient care
Coordinate development of research protocols and treatment plans with physicians, pharmacists, other nurses, research coordinators, and pharmaceutical companies
Active participation in the development of protocol case report forms and progress notes
Disseminate clinical expertise and best practices related to clinical research through presentations, publications, and/or interactions with nursing colleagues
Serve as an expert in specialty area (ex. Grant reviewer, editorial board, presenter)
Participate in query and analysis of research data
Generate practice questions as a result of new study procedure or intervention
Collaborate with interdisciplinary team to develop innovations in care delivery that have potential to improve patient outcomes and data collection.
Identify questions appropriate for clinical nursing research as a result of study team participation (ex. Viral shedding studies for gene therapy and implications for nurses administering IP)
Mentor junior staff and students participating as members of the research team
Perform secondary data analysis to contribute to the development of new ideas
Serve as a resource to the new investigator
Clinical Practice
Collects comprehensive data pertinent to the research protocol requirements and the research participant's health and/ or situation. Some data collection occurs via telephone contact in off hours.
Provide oversight of administration of medications, study drugs, or study interventions, as appropriate.
Administer investigational products in approved settings
Staff nurses caring for research patients may not be familiar with the research process- must work alongside the assigned bedside nurse to provide necessary information about the research study including intervention and potential adverse events
Conduct study interventions in accordance with PSOM and health system policies.
Provide oversight and coordination of radiographic imaging and laboratory findings.
Conduct assessments, collect medical history, and adverse event assessment.
Discuss advanced assessment of patient/ family situation as it relates to adverse event attribution defined by the Principal Investigator.
Monitor patient care, assess patient status, and monitor treatment side effects.
Obtain specimens (including venipuncture)
Provide patient and family education and support. Ensure patients are educated regarding the protocol specifics and study drugs.
Demonstrate understanding of standard of care activities related to the care of the research participants and requirements of the protocol in which they are enrolled.
Demonstrate ability to glean information from multiple sources and integrate that information into clinical practice while maintaining fidelity to the research protocol.
Study Management
Demonstrate knowledge of pathophysiology, pharmacology, and toxicology as related to medicines discovery and development
Coordinate activities of team in caring for patients
Coordinate patient visits and any necessary testing
Maintain Informed Consent for the duration that the patient is participating in the trial. Follow GCP guidelines.
Conduct initiation, monitoring, and close-out visits with sponsors and/or CROs.
Recruit and screen potential study patients as specified per assigned protocols. Confirm patient eligibility and registration.
Complete case report forms (CRFs), and resolve data queries with sponsors and CROs.
Obtain records required to complete CRFs.
Process and ship biologic specimens (blood, urine, stool, nasal swabs, serum, etc) as directed by the clinical trial protocol
Obtain diagnostic materials such as slides from pathology and/or scans from radiology and ship to sponsor/independent review per protocol guidelines.
Attend investigator and site initiation meetings.
Adhere to all University of Pennsylvania, ICF, and FDA guidelines.
Participate in the conduct of audits by study sponsors, CROs, the FDA, NCI, and Penn Regulatory bodies (OCR, Cancer Center DOCM), and other groups.
Prepare and process all regulatory documentation through the Institutional Review Board (IRB) and other entities as required, including amendments, continuing reviews, and adverse event reporting.
Prepare and process all regulatory documentation with pharmaceutical companies and clinical research organizations (CROs).
Resolve regulatory related queries with IRB, study sponsors, and CRO.
Conduct initiation, monitoring and closeout visits with sponsors and/or CROs.
Technology/ Informatics
Utilizes appropriate information and technology to communicate, manage knowledge, mitigate error, and support decision making across the continuum.
Searches, retrieves, and manages data needed to make decisions, using information and knowledge management systems
Ability to create clear treatment plans for administration of investigational interventions in collaboration with the pharmacy and IT teams that can be utilized in the Electronic Medical Record by clinical and research personnel
Serve as an expert and champion in the use of technologies that support clinical decisions making, error prevention, and protection of patient privacy
Assists others in retrieving and managing data needed to make decisions, using information and knowledge management systems
Leadership
Effectively collaborates and applies innovative, systems thinking to engage in systematic, evidence-based problem solving and decision making to promote effective changes within a complex care delivery system.
Exemplifies the ability to build consensus and arrive at a common understanding through effective and skilled communication
Analyzes and interprets the barriers to effective communication within the health care setting and develops strategies to improve outcomes
Effectively engages in the process of cooperation, coordination, and collaboration in an effort to provide for safe, quality outcomes for patients within inter and intra-professional teams, including virtual teams.
Perform additional duties as assigned.
Qualifications
Bachelor's degree required, BSN preferred with 2-3 years of relevant experience or equivalent combination of education and experience required, MSN preferred.
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