Clinical Research Advanced Practice Provider

University of Pennsylvania Perelman School of Medicine

About The Position

Clinical Research Advanced Practice Provider (APP) working in an Infectious Diseases research group with research protocols evaluating HIV vaccines and biologics to prevent HIV infection and vaccine to prevent other infectious diseases. This position is a specialized clinical and research practice role focused on maintaining equilibrium between care of the research participant and fidelity to the clinical research protocol. This specialty practice incorporates human subject protection; care coordination and continuity; contribution to clinical science; clinical practice; and study management. 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. Clinical Research Advanced Practice Provider must have licensure as a Nurse Practitioner or Physician Assistant in this role, and be in good standing to practice in the Commonwealth of Pennsylvania to provide comprehensive professional population appropriate care in a multi-disciplinary environment. All Clinical Research Advanced Practice Provider's function under the guidelines as designed by the University of Pennsylvania Health System Office of Medical Affairs medical staff guidelines and are credentialed through that body. The Clinical Research Advanced Practice Provider will be held accountable through a formal job description, delineation of privileges, and through their agreement with their collaborating physician and a Collaborative Practice Agreement. All clinical work hours and associated requirements will be defined and managed under the direction of the collaborating physician. The Clinical Research Advanced Practice Provider works directly with Physician Investigators on clinical research assisting with patient evaluations and management through their course of therapy. This area of research requires dedicated attention and care to ensure subject safety and well-being. The successful candidate will comply with all policies relating to UPHS, JCAHO, GCP and other regulatory standards. The CRAPP contributes to excellence in education, leadership, research, professional contribution and practice.

Requirements

The Clinical Research Advanced Practice Provider must hold licensure as a Certified Registered Nurse Practitioner or Physician Assistant and be in good standing to practice in the Commonwealth of Pennsylvania.
Masters of Science, Masters of Arts, and 5 to 7 years experience or equivalent combination of education and experience is required.
CRNP must be reviewed by the Credentials Committee and Approved by the Medical Board.
PA RN licensure (RN) RN
PA CRNP licensure (CRNP) CRNP
PA Prescriptive Authority
DEA may be required
National Board Certification
BLS/CPR, as a healthcare provider as per the American Heart Association (For providers in the ambulatory setting)
ACLS (For providers in the acute care setting)
Master's Degree as Physician Assistant and 5 to 7 years experience or an equivalent combination of education and experience is required.
The PA must be reviewed by the Credentials Committee and approved by the Medical Board.
Graduate of accredited Physician Assistant Training Program
Pennsylvania licensure as a Physician Assistant
PA Prescriptive Authority
DEA may be required
National Board Certification by NCCPA BLS/CPR, as a healthcare provider as per the American Heart Association (For providers in the ambulatory setting)
ACLS (For providers in the acute care setting)
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

Responsibilities

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 ensures fidelity to the study protocols and allows for safe and effective collection of clinical research data
Provide nursing leadership within the interdisciplinary team, and supervision of other clinical research personnel
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 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.
Speaks out on local, regional, national, international policy issues
Involved with Professional Organizations and Committees
Publication/ authorship of manuscript, book chapter, journal article
Provide direct clinical care for patient population according to established protocols and utilizes evidence based practice standards in collaboration with the team.
Identifies self properly to patient and family and clarifies the role of the Clinical Research Advanced Practice Provider
Gather information from participants through history taking and physical exam
Formulate a differential diagnosis based on assessment, history, physical examination, and diagnostic test results
Use complex data and information obtained during interview, examination, and diagnostic processes in identifying diagnoses and determining appropriateness for study participation
Integrate assessment strategies, diagnostic strategies, and therapeutic interventions that reflect current evidence consistent with the research protocol objectives including data, research, literature, and expert clinical knowledge
Provide oversight of administration of medications, study drugs, or study interventions, as appropriate.
Use prescriptive authority, procedures, referrals, treatments, and therapies in accordance with state and federal laws and regulations
Prescribe traditional and integrative evidence-based treatments, therapies, and procedures that are compatible with the research participant’s cultural preferences and norms
Prescribe evidence-based pharmacological agents and treatments according to clinical indicators and results of diagnostic and laboratory tests
Provide clinical consultation for the research participant and professionals related to complex clinical cases to improve care and research participant outcomes.
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.
Responsible to participate in orientation of new research personnel.
Demonstrate proficiency in delivering patient care
Contribute to patient care in a meaningful way
Serve as a resource to team members
Demonstrate knowledge of the system and focus on holistic patient care v. episodic care
Collaborate with all team members and seeks consultation as appropriate
Identify clinical practice gaps
Coordinate activities of team in caring for patients.
Coordinate patient visits and any necessary testing.
Engage in a systematic evaluation process to revise the healthcare plan to enhance its effectiveness within the parameters of the research protocol
Uses the results of the evaluation to make or recommend process, policy, procedure, or protocol revisions when warranted
Advance interprofessional healthcare and research plan of care documentation and communications, rationales for plan of care changes, and collaborative discussions to improve research participant outcomes and maintain fidelity to the research protocol
Model expert practice to interprofessional team members and research participants
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.
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.
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.
Advance interprofessional activities including, but not limited to, education, consultation, management, technological development, or research to enhance outcomes
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
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.
Demonstrates evidence of involvement in mentee/mentor relationship
Member of organizational committee and/ or leading local committee
Leads community outreach
Perform 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.