FSP Clinical Research Associate 2 - West Coast - Oncology & Non-Oncology

Fortrea•Washington, NV

13d•$100,000 - $112,000•Hybrid

About The Position

The FSP team is seeking a Clinical Research Associate 2 with two years of clinical monitoring experience, based in the San Francisco, California area or elsewhere on the West Coast, with oncology experience. The role involves approximately 8–10 on-site days per month, in a mix of on-site and remote work, and requires 60% overnight travel. The CRA 2 uses clinical research knowledge and judgment to support participants in clinical trials and respond to emergency situations in accordance with clinical research standards. The role covers site monitoring and management, registry management, data and safety review, and coordination with study staff, vendors, clients, and colleagues. Work is performed in an office environment with exposure to electrical office equipment, as well as frequent travel to client and site locations and occasional domestic and international travel. Varied hours may be required. The target pay range is $100,000–$112,000.

Requirements

University or college degree, or certification in a related allied health profession from an appropriately accredited institution (for example, nursing licensure).
Two years of clinical monitoring experience.
Ability to travel overnight 60% of the time.
Comfort working in a fast-paced environment where protocol deviations are not allowed and missed timelines can create quality issues.
Ability to adapt and reprioritize as priorities change.
Teamwork and interpersonal skills.
Comfort working in a technology-based environment where data is collected electronically.
Ability to sit for extended periods and operate a vehicle safely.
Ability to make fast, simple, repetitive movements with the fingers, hands, and wrists.
Ability to occasionally crouch and stoop, and frequently bend and twist the upper body and neck.
Ability to access and use a variety of in-house and off-the-shelf computer software.
Ability to lift or carry light to moderate objects, including luggage and a laptop, up to 15–20 pounds.
Regular and consistent attendance.

Nice To Haves

Oncology experience.

Responsibilities

Conduct all aspects of study site monitoring, including routine monitoring, site close-out, maintenance of study files, and pre-study and initiation visits.
Liaise with vendors and perform other assigned duties.
Manage sites as prescribed in project plans, including general on-site monitoring.
Ensure study staff receive the materials and instructions needed to enroll participants safely and conduct the protocol.
Verify that informed-consent procedures and protocol requirements are followed according to applicable regulatory requirements.
Protect data integrity by reviewing source documents and monitoring Case Report Forms (CRFs) and other data collection tools for missing or implausible data.
Perform registry management as prescribed in project plans and undertake feasibility work when requested.
Complete Serious Adverse Event (SAE) reporting, prepare reports and narratives, and follow up on SAEs.
Independently review CRFs and generate and resolve queries according to established data-review guidelines using Fortrea or client data-management systems, as assigned.
Assist with training new employees, including through co-monitoring.
Coordinate designated clinical projects as a Local Project Coordinator, with supervision if applicable, and act as a local client contact when assigned.
Perform other duties assigned by management.