Clinical Research Advanced Practice Provider

Job Description Summary

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.

Job Description

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 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.

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.
• Speaks out on local, regional, national, international policy issues
• Involved with Professional Organizations and Committees
• Publication/ authorship of manuscript, book chapter, journal article

Clinical Practice

In collaboration with the Principal Investigator and study the Clinical Research APP will:

• 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

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.
• 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.

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.
• Advance interprofessional activities including, but not limited to, education, consultation, management, technological development, or research to enhance outcomes

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.
• 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.

CONTINGENT UPON FUNDING

Qualifications

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.

CERTIFIED REGISTERED NURSE PRACTIONER (CNRP):

• 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)

PHYSICIAN'S ASSISTANT (PA):

• 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)

ADDITIONAL QUALIFICATIONS:

• 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 - City, State

Philadelphia, Pennsylvania

Department / School

Perelman School of Medicine

Pay Range

$89,500.00 - $120,000.00 Annual Rate