Sr. CRA 2, FSP - West Coast - Invitro Diagnostics

Responsibilities

• Utilize skills, knowledge, and clinical judgement to provide high standard of care for participants in clinical trials and respond to emergency situations.
• Monitor all aspects of study site 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.
• Manage all aspects of site management as prescribed in the project plans.
• Ensure study staff receive proper materials and instructions to safely enter patients into the study.
• Verify adherence to informed consent procedures and protocol requirements according to applicable regulatory requirements.
• Monitor data for missing or implausible data and ensure the integrity of the data submitted on Case Report Forms (CRFs).
• Undertake feasibility work when requested.
• Complete Serious Adverse Event (SAE) reporting, process production of reports, narratives, and follow up of SAEs.
• Perform CRF review, query generation, and resolution against established data review guidelines on Fortrea or client data management systems as assigned by management.
• Aid in training of new employees, such as co-monitoring.
• Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable) and 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).
• 4+ years of Clinical Monitoring experience.
• 50-60% overnight travel.