Round Rock, TX30+ days ago
Management of Clinical Trial Patients • Collaborates with the investigator to ascertain study patient eligibility for a clinical trial, including documentation of criteria specified in the protocol • Educates the patient and family regarding protocol participation • Provides patient education regarding required study procedures • If the Research Coordinator is a Registered Nurse, educates the patient and family regarding clinical condition, and/or disease process • If the Research Coordinator is not a RN, he/she will schedule educational time with a RN • Identifies patients who require increased nursing assessment and management in addition to the clinical trial requirements and collaborate with other members of the healthcare team to ensure patient safety • If the Research Coordinator is a Registered Nurse, identifies patients who require increased nursing assessment and management in addition to the clinical trial requirements and collaborate with other members of the healthcare team to ensure patient safety • Coordinates, schedules, and ensures timely completion of protocol-required events and other requirements (e.g., pharmacokinetics or -dynamics, scans, study visits, QOL,) • Assesses individual patients for physical, psychosocial, and financial factors that could impact adherence with study requirements and implement interventions as necessary • Evaluates patient's adherence to and documentation of self-administered protocol agents and the return of such agents • Collaborates with the investigator to determine disease response as defined by the protocol and communicates findings to the study team and other care providers • Evaluates patient's adherence to and documentation of self-administered protocol agents and return of such agents • Collaborates with the investigator to determine if any treatment schedule or drug dose modification is necessary and communicates findings to the study team and other care providers • Ensures appropriate communication between research and clinical staff related to patient-specific care needs • Ensures evidence-based symptom management as permitted by the protocol. • Informed Consent • Identifies and intervenes to address barriers to effective informed consent discussions and decision making (e.g., literacy, capacity, language, distress, lack of time, therapeutic misconception) • Describes and abides by institutional policy and processes for informed consent • Ensures that the most current version of the IRB approved protocol consent document is used by the physician investigator when consenting or re-consenting a patient • Collaborates with the physician investigator to ensure initial and ongoing consent process is performed and documented • Assesses ongoing consent through discussions with patients and reinforcement of education • Assesses patient's understanding of the information provided during the informed consent process • Ensures timely re-consenting as needed by the physician investigator • Demonstrates understanding of tiered consent process when optional correlative studies (e.g., biospecimen, quality of life, patient-reported outcomes collections) are involved • Confirms informed consent is obtained prior to performing any study specific tasks.