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Posted Job Title

Clinical Research Nurse D (Department of Clinical And Translational Research)(Part-Time)

Job Profile Title

Clinical Research Nurse D

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.

The Part-time Clinical Nurse D will assist in the coordination and implementation of Phase I – IV clinical trials for patients. This individual will work under supervision of the Director of Research or applicable department specific supervisor role (ex. Practice Manager/ Program Manager) with the Principal Investigators.

Job Description

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.

The Part-time Clinical Research Nurse D will assist in the coordination and implementation of Phase I – IV clinical trials for patients. This individual will work under supervision of the Director of Research or applicable department specific supervisor role (ex. Practice Manager/ Program Manager) with the Principal Investigators. This position will be scheduled to work 20 hrs/wk.

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 a 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

Participates in the evaluation of patients subscribing to managed care insurance providers who require special consideration as to site of service and participation on approved clinical protocols.

Determines daily and long-term staffing needs for outpatient activities, including coordinating physician coverage.

• 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 investigator initiated protocol and case report forms and progress notes.

Disseminate clinical expertise and best practices related to clinical research through presentations, publications, and/or interactions with nursing, physician, pharmacy, and collaborative interdisciplinary faculty 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.

Bring novel studies to the department.

Evaluates research findings in the specialty area and translates them to practice

Develops research studies particularly in the areas affecting quality of life of patients and their families treated with investigational interventions.

• Clinical Practice

Collects 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

Staff nurses caring for research patients may not be familiar with the research process- the CRN 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.

Responsible to participate in orientation of new research personnel.

• 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 blood, urine and serum specimens for each trial.

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. Review protocol for nursing feasibility, logistical operational consideration, and patient population ability to participate in study related activities.

Adhere to all University of Pennsylvania, ICF, and FDA guidelines.

• Professionalism

Demonstrate a commitment to the nursing profession through lifelong learning, adherence to ANA’s Code of Ethics for Nurses, participation in a professional organization and advancing community outreach

• Teamwork

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.

• 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

Applies clinical expertise to the selection, design, implementation and evaluation of information systems and their application in the clinical setting

Stays knowledgeable about technology on the horizon

• 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

Demonstrates ability to lead the research team, represent the department, and manage projects.

Regulatory Responsibilities

• 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.

REQUIREMENTS: EXPERIENCE, CREDENTIALS AND SKILLS

• Registered Nurse: Licensure in Commonwealth of Pennsylvania without restriction or limitation and minimum 4 years experience.

• Obtain 30 CEUs every 2 years to maintain licensure

• For state licenses where Pennsylvania participates in a multi-state compact an RN holding a multi-state license (MSL) would be considered to meet the requirement for Pennsylvania state licensure

• Bachelor’s degree, BSN and 5-7 years of relevant experience preferred.

• At least 3 years’ clinical research experience strongly preferred

• MSN or Master’s degree in science related field strongly preferred

• Supervisory experience in research domain strongly preferred

• Applicable professional certification may be required (ex: OCN, CCRP, CRN-BC)

• ACLS preferred and may be required in specific environments (ICU settings, ED, etc.)

• Basic Life Support Certification (CPR) required and maintained every 2 years

• 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.

Cover letter and resume required with application

Weekly Hours: 20

Targeted Pay Range: $47,535.50-$52,404.50

This Targeted Pay Range is only applicable to this job posting. All salary offers are made based on the candidate’s qualifications, experience, skills, and education as they directly relate to the requirements of the position, as well as internal and market factors and grade profile.

Job Location - City, State

Philadelphia, Pennsylvania

Department / School

Perelman School of Medicine

Pay Range

Salary offers are made based on the candidate’s qualifications, experience, skills, and education as they directly relate to the requirements of the position, as well as internal and market factors and grade profile.

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.

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. There’s always something going on at Penn, whether it’s a new exhibit at the Penn Museum, the latest music or theater presentation at the Annenberg Center, or the Penn Relays at Franklin Field to name just a few examples. As a member of the Penn community, you’re right in the middle of the excitement—and you and your family can enjoy many of these activities for free.

• 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.

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  To learn more, please visit: https://www.hr.upenn.edu/PennHR/benefits-pay

  The University of Pennsylvania's special character is reflected in the diversity of the Penn community. We seek talented faculty and staff who will constitute a vibrant community that draws on the strength that comes with a substantive institutional commitment to diversity along dimensions of race, ethnicity, gender, sexual orientation, age, religion, disability, veteran status, interests, perspectives, and socioeconomic status. Grounded in equal opportunity, nondiscrimination, and affirmative action, Penn's robust commitment to diversity is fundamental to the University's mission of advancing knowledge, educating leaders for all sectors of society, and public service. The University of Pennsylvania prohibits unlawful discrimination based on 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.