Ensures initial and ongoing consent process is performed and documented in compliance with FDA, Good Clinical Practice (GCP), institutional sponsor, IRB, and other applicable
regulations, guidance’s, and policies.
Participates in the education of clinical trial patients about their clinical trial and significant new information that is forthcoming during or after the conduct of the trial.
Ensures ordering and scheduling of all procedures/exams that are required to enroll patients, for further assessment for adverse events, and for evaluation of disease response to study treatment according to protocol.
Ensures adherence to protocol schedule of events, study drug, and other requirements.
Ensures the successful completion of correlative components of the clinical trial (pharmacokinetics and quality of life studies).
Orders, prescribes, and recommends interventions in plan of care that reflects expected outcomes.
Implementation: Institutes necessary actions as outlines in the plan of care.
Collaborates with research and primary care team members to ensure implementation of plan
Implements physician/PI/Sub-PI orders per protocol.
Works in collaboration with study team to assure good documentation clinical practices and assures there is a source related to the documentation being performed.
Documents assessment, management, and evaluation in source documents for patients on clinical trials as appropriate to the protocol and role.
Documents adverse events according to CTCAE criteria.
Provides patient/family education regarding disease processes, treatment options, treatment outcomes, possible complications, medications, drug handling (oral treatments), discharge/follow-up planning and lifestyle modification.
Integrates current knowledge of professional issues, trends in health care and technological advances into scope of practice.
Communicates plan of care to team members.
Assists in the management of family dynamics and coping mechanisms during acute and chronic phases of patient care.
Evaluation: Evaluates the patient’s progress in attaining expected outcomes by follow up with
collaborating physician and staff
Evaluates disease response results and physical assessment data in conjunction with the principal investigator or sub investigator to determine response per the protocol.
Assures patient is transferred to appropriate physician/specialty once study completed.
Consultation/Collaboration: Consults with collaborating physician(s) on implementation, evaluation and revision of treatment plan.
Ensures ongoing formal and informal communication regarding clinical trials with team members.
Promotes ongoing compliance with key ethical concepts by the research team, including informed consent, documentation, respect for persons, beneficence, and justice.