p>• 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 not an RN, he/she will schedule educational time with a RN • 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.