Clinical Research Nurse Supervisor

Perelman School of Medicine at the University of Pennsylvania

About The Position

Clinical Research Nursing working in Infectious Diseases Prevention research group with research protocols evaluating HIV vaccines and biologics to prevent HIV infection and vaccines to prevent other infectious diseases. This position 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. In addition, the supervisor role has supervisory, leadership, and educator responsibilities.

Requirements

5-7 years of experience along with Registered Nurse with Licensure in Commonwealth of Pennsylvania without restriction or limitation required.
BSN preferred.
At least 3 years’ clinical research experience strongly preferred
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
Expert knowledge of IRB and human research protection regulations required

Nice To Haves

MSN or Master’s degree in science related field strongly preferred
ACLS preferred and may be required in specific environments (ICU settings, ED, etc)
Applicable Professional Certification preferred (ex. CCRP, CRN-BC, OCN)
Supervisory experience in research domain strongly preferred
Applicable clinical supervisory experience preferred
Staff education and orientation experience preferred

Responsibilities

Provide direct supervision to Clinical Research Nurses and other support staff (if applicable) on a daily to weekly basis depending upon skill level of individual and phase of orientation
Determine workload and assignments for research personnel
Ensure all staffing and resource needs are adequately and appropriately allocated to meet the programmatic needs of the department
Responsible for or participate in the hiring and performance management of staff
Act as liaison between new hire and department and other entities including HUP, Penn, pharmaceutical companies, cooperative groups and other departments on the University campus
Create orientation and training programs, specific to individual new hire’s skill set, educational preparation, and prior professional experience
Implement and continually modify a comprehensive orientation program for newly hired research nurses, during the introductory/orientation period
Continually assess progress of research nurses through phases of orientation, i.e., clinical, data management, laboratory, regulatory, at the University of Pennsylvania
Coordinate and conduct ongoing staff education
Coordinate and ensure up-to-date staff certification and licensure for research personnel
Actively work towards process improvement including staff professional development opportunities and career advancement opportunities within Penn
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
Demonstrates ability to lead the research team, represent the department, and manage projects
Engages with research-specific and department leadership forwarding the research mission of the faculty, assuring protocol feasibility (population, resources, etc), accurate budgets to conduct research, aligns with department research mission.
Serve as point-of-contact for triage, laboratory, clinic, infusion, radiology, advanced practitioners, inpatient, billing and pharmacy when research staff is unavailable or when issues involve escalation
Serve as point of contact for evenings, weekends and University holidays if questions arise or for research patients.
Develop tools and organization structures to support the program including standard operating procedures and guidelines for research personnel.
Participates in the design, review, and evaluation of Quality Improvement (QI) data and initiatives at the department or service-line level
Considers role of external stakeholders in QI initiatives and priorities
Educate clinicians and interdisciplinary team on the research process and effective strategies for successful implementation of research protocols within the care delivery system
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.
Demonstrates ability to lead the research team, represent the department, and manage projects
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
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
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
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 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
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
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- 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.
Demonstrate knowledge of pathophysiology, pharmacology, and toxicology as related to medicines discovery and development
Coordinate activities of team in caring for patients
Participate on research team calls and correspond with research team
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
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
Additional duties as assigned.

Benefits

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.
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.
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.
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.
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.
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.
Penn provides an array of resources to help you advance yourself personally and professionally.
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.
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.
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 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 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.
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.