Research Coordinator

Requirements

• Adheres to patient care standards and communicates effectively
• Assists with screening patients and oversees on-study requirements
• Identifies and intervenes to address barriers to effective informed consent discussions and decision making
• Documents all patient encounters in the legal medical record per licensure and institutional requirements
• Ensures timely, accurate, and complete reporting of serious adverse events, unanticipated problems, deviations, violations, and noncompliance to the IRB and sponsor
• Collaborates with the Principal Investigator, pharmacy, and other appropriate personnel to ensure proper use of and accountability for study drugs
• Provides protocol specific education to clinical staff
• Facilitates and participates in the preparation for and conduct of meetings/teleconferences with sponsors, monitors, and auditors
• Coordinates, schedules, and ensures timely completion of protocol-required events and other requirements
• Evaluates patient’s adherence to and documentation of self-administered protocol agents and 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
• Ensures appropriate communication between research and clinical staff related to patient-specific care needs
• Ensures evidence-based symptom management as permitted by the protocol
• 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
• Ensures that relevant data from source documents are abstracted and entered into CRFs in a timely and accurate manner