Clinical Research Associate II, Phase I - California

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

• 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 to ensure study staff have received proper materials and instructions to safely enroll patients.
• Ensure protection of study patients by verifying informed‑consent procedures and protocol requirements are adhered to according to applicable regulatory requirements.
• Ensure integrity of data submitted on Case Report Forms (CRFs) or other data‑collection tools by careful source‑document review.
• Monitor data for missing or implausible entries.
• Responsible for all aspects of registry management as prescribed in the project plans.
• Undertake feasibility work when requested.
• Complete Serious Adverse Event (SAE) reporting, produce reports and narratives, and follow up on SAEs.
• Independently perform CRF review; generate and resolve queries against established data‑review guidelines on Fortrea or client data‑management systems as assigned.
• Assist with training of new employees, e.g., 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.
• Comfortable working in a fast‑paced environment with strict protocol adherence.
• Ability to adapt to constantly changing priorities.
• Strong teamwork and people skills.
• Technology‑based work environment with electronic data collection.

Work Environment

Work is performed in an office environment with exposure to electrical office equipment. Frequent travel to client/site locations with occasional domestic and international travel.

Physical Requirements

• Ability to sit for extended periods and operate a vehicle safely.
• Repetitive hand movements with the ability to make fast, simple, repeated motions of the fingers, hands, and wrists.
• Occasional crouching, stooping, and frequent bending and twisting of the upper body and neck.
• Ability to access and use a variety of computer software developed both in‑house and off‑the‑shelf.
• Light to moderate lifting and carrying of objects, including luggage and a laptop computer, with a maximum lift of 15–20 lb.
• Regular and consistent attendance.
• Varied hours may be required.

Pay

Target Pay Range: $100 K – $120 K – Remote