Research Coordinator

Requirements

• Identifies primary and secondary study objectives and outcome measures
• Adheres to applicable federal, state, and institutional regulations, policies, and procedures related to clinical research
• Complies with NEXT Oncology SOPs
• Provides protocol specific education to clinical staff
• Facilitates and participates in the preparation for an conduct of meetings/teleconferences with sponsors, monitors, and auditors
• Provides timely, accurate, and complete reporting of serious adverse events, unanticipated problems, deviations, violations, and noncompliance to the IRB and sponsor
• Contributes to the development of corrective and preventive action plans for unanticipated problems, deviations, violations, and issues of noncompliance
• Identifies and intervenes to address barriers to effective informed consent discussions and decision making
• 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 are involved
• Confirms informed consent is obtained prior to performing any study specific tasks
• 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
• Coordinates, schedules, and ensures timely completion of protocol-required events and other requirements
• 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
• Documents all patient encounters in the legal medical record per licensure and institutional requirements
• Obtains documents from outside providers or laboratories that are needed as part of the research data
• Educates other research team members and clinical staff regarding appropriate and accurate source documentation for patients in clinical trials
• Assesses documentation or discrepancies and ensures that inaccurate or discrepant documentation is addressed in the medical record or other source documents
• Maintains the privacy and confidentiality of patients' source documents
• Maintains specified study documents in the Research Coordinator files
• Participates in the development of approved source documents, templates, or forms
• Adheres to the data management plan per NEXT SOPs and sponsor data management plan
• Assists in troubleshooting data entry issues
• Ensures that relevant data from source documents are abstracted and entered into CRFs in a timely and accurate manner
• Ensure that data recorded on the CRFs can be verified within the source documents
• Participates in quality control activities to ensure data integrity, including timely responses to database or sponsor queries
• Enters data into electronic data capture for SAEs as appropriate

Benefits

• Health and welfare benefits
• Other forms of compensation