Clinical Research Associate II, Phase I - California at Fortrea in Remote California

Job description

• Our Phase I team is currently seeking a Clinical Research Associate with 1+ years of experience. Ideal candidates would have phase I experience and reside in California.

Responsibilities

• You will utilize your skills, knowledge, and clinical judgement to provide a high standard of care for participants in clinical trials and respond to emergency situations based upon clinical research standards.
• Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned -
• Responsible for all aspects of site management as prescribed in the project plans
• General On-Site Monitoring
• Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study
• Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements
• Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document Monitor data for missing or implausible data
• Responsible for all aspects of registry management as prescribed in the project plans - Undertake feasibility work when requested
• Complete Serious Adverse Event (SAE) reporting, process production of repo11s, narratives and follow up of SAEs
• Independently perform CRF review; query generation and resolution against established data review guidelines on Fortrea or client data management systems as assigned by management
• Assist with training of new employees, eg. co-monitoring
• Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable) and may act as a local client contact as assigned
• Perform other duties as assigned by management

Requirements

• University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g. nursing licensure)
• 1+ years of Clinical Monitoring experience
• Phase I experience
• 40-50% overnight travel

Skills

Required

• Clinical Monitoring
• Phase I experience
• Clinical judgement
• Knowledge of clinical research standards
• Source document verification
• CRF review
• Query generation and resolution
• SAE reporting
• Teamwork
• Adaptability
• Prioritization
• Computer software proficiency

Benefits

• Target Pay Range: $100 - $120K