FSP Clinical Research Associate 2 - West Region

About the role

Our FSP team is currently seeking a CRA 2 in the West Region with 2 years of monitoring experience. This role involves 8–10 days on site per month, combining onsite and remote work.

Responsibilities

• Utilize clinical skills, knowledge, and judgment to provide high-standard care for clinical trial participants and respond to emergency situations per clinical research standards.
• Conduct all aspects of study site monitoring, including routine and close-out visits, maintenance of study files, and pre-study and initiation visits.
• Liaise with vendors and perform other duties as assigned.
• Manage sites as prescribed in project plans, including feasibility work when requested.
• Ensure proper informed consent procedures and protocol adherence to protect study patients and maintain data integrity.
• Monitor data for missing or implausible entries on Case Report Forms (CRFs) or other tools.
• Complete Serious Adverse Event (SAE) reporting, produce reports, narratives, and follow up on SAEs.
• Independently perform CRF review, query generation, and resolution using Fortrea or client data management systems.
• Assist with training 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.

Requirements

• University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure).
• 2 years of Clinical Monitoring experience.
• 60% overnight travel.

Work Environment

• Fast-paced environment requiring strict adherence to study protocols and timelines.
• Constantly changing priorities requiring adaptability and prioritization.
• Teamwork and strong interpersonal skills are essential for smooth study operations.
• Technology-based role with direct data collection in an electronic environment.
• 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 fast, simple, repeated motions of fingers, hands, and wrists.
• Occasional crouching, stooping, and frequent bending and twisting of the upper body and neck.
• Ability to use a variety of in-house and off-the-shelf computer software.
• Light to moderate lifting and carrying (e.g., luggage and laptop) up to 15–20 lbs.
• Regular and consistent attendance with varied hours as required.

Pay

Target Pay Range: $100–$112K