Reporting to: Assistant/Associate Director of Clinical Monitoring, Senior CRA Manager, or CRA Manager
Job Purpose / Summary
The Clinical Research Associate completes project activities associated with monitoring functions of phase I through phase IV clinical research studies while continuing to develop knowledge of drug development process, International Council for Harmonisation (ICH) / Good Clinical Practice (GCP) and applicable local regulations; provides clinical and technical support for CRAs and administrative staff; and performs management of study site activities to ensure integrity of clinical data in adherence to all applicable regulatory guidelines and Standard Operating Procedures (SOPs).
Duties and Responsibilities
Serves as main CTI contact for assigned investigative sites.
Manages investigative site activity for multiple protocols / indications and provides ongoing updates of site status to Study Manager / sponsor.
Creates and implements subject enrollment strategies for assigned investigative sites.
Conducts study site visits (pre-study [PSV], initiation [SIV], monitoring [MV], and close-out [COV]) and completes site visit deliverables within given timelines in Monitoring Plan.
Ensures proper storage, dispensation, and accountability of all investigational product (IP) and trial-related material.
Maintains tracking records for assigned sites including tracking of subject status, subject case report form (CRF) retrieval / source document review (SDV), regulatory documents, and IP.
Completes in-house monitoring activities as appropriate, such as updating in-house site files, conducting remote monitoring for electronic data capture (EDC) studies, and completing visit reports / letters.
Anticipates / identifies site issues and implements corrective actions or escalates to Study Manager / sponsor as necessary.
Completes site selection and pre-study activities to identify and evaluate potential Investigators.
Conducts project-specific administrative activities as member of Project Team.
Assists in preparing and coordinating Project Investigator meetings and attends meetings as necessary.
Attends sponsor meetings as necessary.
Serves as mentor / trainer for CRAs including in-house and on-site training.
Assists with project-specific administrative activities as member of Project Team.
Increases knowledge of drug development process, therapeutic areas, GCPs, and any applicable local regulatory requirements.
Minimum of 2 years clinical nursing experience, or
Minimum of 1 year clinical research monitoring experience
Bachelor’s Degree in allied health fields, such as nursing, pharmacy, or health / natural science, or
RN with Associate’s Degree with at least 2 years clinical nursing experience, or
Equivalent experience as determined by CTI Management and Human Resources (HR)