Clinical Research Nurse C

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. 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 the 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 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. Participate in the development of investigator initiated 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 Collect comprehensive data pertinent to the research protocol requirements and the research participant’s health and/ or situation. Provide oversight of administration of medications, study drugs, or study interventions, as appropriate. Administer investigational products in approved settings. 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 Utilize appropriate information and technology to communicate, manage knowledge, mitigate error, and support decision making across the continuum. Search, retrieve, and manage data needed to make decisions, using information and knowledge management systems. 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. Assist others in retrieving and managing data needed to make decisions, using information and knowledge management systems. Effectively collaborate and apply innovative, systems thinking to engage in systematic, evidence-based problem solving and decision making to promote effective changes within a complex care delivery system. Exemplify the ability to build consensus and arrive at a common understanding through effective and skilled communication. Analyze and interpret the barriers to effective communication within the health care setting and develop strategies to improve outcomes. Effectively engage 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. Other duties as assigned. CONTINGENT UPON FUNDING Qualifications Registered Nurse with licensure in the Commonwealth of Pennsylvania without restriction or limitation and 2-3 years of experience required. BSN preferred. Two to three years’ clinical research experience preferred. Basic Life Support Certification (CPR) required and maintained every 2 years. ACLS preferred and may be required in specific environments (ICU settings, ED, etc). Applicable Professional Certification preferred (ex. CCRP, CRN-BC, OCN). Effective problem-solving abilities. Effective communication and writing skills. Ability to multi-task. Demonstrated ability to work as part of a team as well as independently. Knowledge of IRB and human research protection regulations required. Job Location Philadelphia, Pennsylvania Department / School Perelman School of Medicine Pay Range $62,000.00 - $87,561.00 Annual Rate Equal Opportunity Statement The University of Pennsylvania is an equal opportunity employer. Candidates are considered for employment without regard to race, color, sex, sexual orientation, religion, creed, national origin (including shared ancestry or ethnic characteristics), citizenship status, age, disability, veteran status or any class protected under applicable federal, state or local law. Special Requirements Background checks may be required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job. University Benefits Health, Life, and Flexible Spending Accounts : Penn offers comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits to protect you and your family’s health and welfare. You can also use flexible spending accounts to pay for eligible health care and dependent care expenses with pre-tax dollars. Tuition : Take advantage of Penn’s exceptional tuition benefits. You, your spouse, and your dependent children can get tuition assistance here at Penn. Your dependent children are also eligible for tuition assistance at other institutions. Retirement : Penn offers generous retirement plans to help you save for your future. Penn’s Basic, Matching, and Supplemental retirement plans allow you to save for retirement on a pre‑tax or Roth basis. Choose from a wide variety of investment options through TIAA and Vanguard. Time Away from Work : Penn provides you with a substantial amount of time away from work during the course of the year. This allows you to relax, take vacations, attend to personal affairs, recover from illness or injury, spend time with family—whatever your personal needs may be. Long‑Term Care Insurance : In partnership with Genworth Financial, Penn offers faculty and staff (and your eligible family members) long‑term care insurance to help you cover some of the costs of long‑term care services received at home, in the community or in a nursing facility. If you apply when you’re newly hired, you won’t have to provide proof of good health or be subject to underwriting requirements. Eligible family members must always provide proof of good health and are subject to underwriting. Wellness and Work-life Resources : Penn is committed to supporting our faculty and staff as they balance the competing demands of work and personal life. That’s why we offer a wide variety of programs and resources to help you care for your health, your family, and your work‑life balance. Professional and Personal Development : Penn provides an array of resources to help you advance yourself personally and professionally. University Resources : As a member of the Penn community, you have access to a wide range of University resources as well as cultural and recreational activities. Take advantage of the University’s libraries and athletic facilities, or visit our arboretum and art galleries. Discounts and Special Services : From arts and entertainment to transportation and mortgages, you’ll find great deals for University faculty and staff. Not only do Penn arts and cultural centers and museums offer free and discounted admission and memberships to faculty and staff. You can also enjoy substantial savings on other goods and services such as new cars from Ford and General Motors, cellular phone service plans, movie tickets, and admission to theme parks. Flexible Work Hours : Flexible work options offer creative approaches for completing work while promoting balance between work and personal commitments. These approaches involve use of non-traditional work hours, locations, and/or job structures. Penn Home Ownership Services : Penn offers a forgivable loan for eligible employees interested in buying a home or currently residing in West Philadelphia, which can be used for closing costs or home improvements. Adoption Assistance : Penn will reimburse eligible employees on qualified expenses in connection with the legal adoption of an eligible child, such as travel or court fees, for up to two adoptions in your household. #J-18808-Ljbffr