Management of Clinical Trial Patients ā¢ Collaborates with the investigator to ascertain study patient eligibility for a clinical trial, including documentation of criteria specified in the protocol ā¢ Educates the patient and family regarding protocol participation ā¢ Provides patient education regarding required study procedures ā¢ If the Research Coordinator is a Registered Nurse, educates the patient and family regarding clinical condition, and/or disease process ā¢ If the Research Coordinator is not a RN, he/she will schedule educational time with a RN ā¢ 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 ā¢ If the Research Coordinator is not an RN, he/she will schedule educational time with a RN ā¢ Coordinates, schedules, and ensures timely completion of protocol-required events and other requirements (e.g., pharmacokinetics or -dynamics, scans, study visits, QOL) ā¢ Assesses individual patients for physical, psychosocial, and financial factors that could impact adherence with study requirements and implement interventions as necessary ā¢ Evaluates patient's adherence to and documentation of self-administered protocol agents and the return of such agents ā¢ Collaborates with the investigator to determine disease response as defined by the protocol and communicates findings to the study team and other care providers ā¢ Evaluates patient's adherence to and documentation of self-administered protocol agents and return of such agents ā¢ 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 ā¢ Ensures appropriate communication between research and clinical staff related to patient-specific care needs ā¢ Ensures evidence-based symptom management as permitted by the protocol. ā¢ Informed Consent ā¢ 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) ā¢ Describes and abides by institutional policy and processes for informed consent ā¢ 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 ā¢ Collaborates with the physician investigator to ensure initial and ongoing consent process is performed and documented ā¢ Assesses ongoing consent through discussions with patients and reinforcement of education ā¢ Assesses patient's understanding of the information provided during the informed consent process ā¢ Ensures timely re-consenting as needed by the physician investigator ā¢ Demonstrates understanding of tiered consent process when optional correlative studies (e.g., biospecimen, quality of life, patient-reported outcomes collections) are involved ā¢ Confirms informed consent is obtained prior to performing any study specific tasks.