FSP Clinical Research Associate 2 - Las Vegas, NV - Oncology

Fortrea•Durham, NC

12d•Hybrid

About The Position

The FSP Clinical Research Associate 2 monitors and manages clinical trial sites, with a focus on oncology studies. The role includes routine monitoring and close-out visits, pre-study and initiation visits, study-file maintenance, vendor liaison, and other site-management activities prescribed in project plans. The position is based in the Las Vegas, Nevada area and involves approximately 8–10 days of onsite work per month, combining onsite and remote work, as well as 60% overnight travel. The CRA ensures study staff receive the materials and instructions needed to conduct the protocol safely, verifies that informed-consent procedures and protocol requirements are followed, and protects the integrity of submitted study data through source-document review and monitoring for missing or implausible data. Additional duties include registry management, feasibility work when requested, serious adverse event reporting and follow-up, independent CRF review and query resolution, assisting with new-employee training, and coordinating designated local clinical projects under supervision when applicable. Work takes place in an office environment with exposure to electrical office equipment and frequent travel to client or site locations, with occasional domestic and international travel. Varied hours may be required. The role requires regular and consistent attendance, safe vehicle operation, extended sitting, repetitive hand movements, occasional crouching and stooping, frequent bending and twisting, and light to moderate lifting and carrying of objects weighing up to 15–20 pounds. 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.
Oncology experience.
Ability to travel overnight 60% of the time.
Comfort working in a fast-paced, technology-based environment with changing priorities and strict study protocols and timelines.
Teamwork and people skills.
Ability to sit for extended periods and operate a vehicle safely.
Ability to perform repetitive hand movements and fast, simple, repeated movements of 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 in-house and off-the-shelf computer software.
Ability to lift and carry objects, including luggage and a laptop computer, weighing up to 15–20 pounds.
Regular and consistent attendance.

Responsibilities

Conduct routine monitoring and close-out of clinical sites, maintain study files, and conduct pre-study and initiation visits.
Liaise with vendors and perform other assigned duties.
Manage sites in accordance with project plans.
Ensure study staff have received the materials and instructions needed to safely conduct the protocol.
Verify that informed-consent procedures and protocol requirements comply with applicable regulatory requirements.
Protect data integrity by reviewing source documents and monitoring for missing or implausible data.
Manage registries as prescribed in project plans and undertake feasibility work when requested.
Complete serious adverse event 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 co-monitoring.
Coordinate designated clinical projects as a Local Project Coordinator, with supervision if applicable, and serve as a local client contact when assigned.
Perform other duties assigned by management.