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.
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- 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.
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
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.
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.
Other duties as assigned.