Research Coordinator

Requirements

• Adheres to applicable federal, state, and institutional regulations, policies, and procedures related to clinical research
• 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 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
• Collaborates with the physician investigator to ensure initial and ongoing consent process is performed and documented
• 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
• Evaluates patient’s adherence to and documentation of self-administered protocol agents and the return of such agents
• Ensures appropriate communication between research and clinical staff related to patient-specific care needs
• Documents all patient encounters in the legal medical record per licensure and institutional requirements
• 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
• 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

• Medical
• Dental
• Vision
• 401k
• Employee Assistance Program
• Life Insurance