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

Fortrea•Durham, NC

12d•Hybrid

About The Position

The FSP Clinical Research Associate 2 conducts clinical-trial site monitoring and site management for oncology and non-oncology studies. The role includes approximately 8–10 days per month onsite, with a mix of onsite and remote work, and requires 60% overnight travel. Candidates are sought in the San Francisco, California area or elsewhere on the West Coast, with oncology experience. The CRA uses clinical judgment and research standards to support participant safety and respond to emergency situations. The CRA oversees study-site monitoring and management, including routine monitoring, site close-out, study-file maintenance, feasibility work when requested, and pre-study and initiation visits. The role also supports registry management, serious adverse event reporting and follow-up, case report form review, query generation and resolution, staff training, vendor liaison, and coordination of designated clinical projects as a Local Project Coordinator when assigned. 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. The work environment is fast-paced, with shifting priorities, strict protocol and timeline requirements, teamwork, and use of electronic data systems. Varied hours may be required. Target pay range is $100,000–$112,000. Applications are accepted on an ongoing basis.

Requirements

University or college degree, or certification in a related allied health profession from an appropriately accredited institution, such as nursing licensure.
Two years of clinical monitoring experience.
Comfort with 60% overnight travel.
Ability to work in a fast-paced environment with strict study-protocol and timeline requirements and changing priorities.
Teamwork and people skills.
Ability to work with electronic data-collection systems and access a variety of in-house and off-the-shelf computer software.
Ability to sit for extended periods and operate a vehicle safely.
Ability to perform repetitive hand movements with both hands, including fast, simple, repeated movements of the fingers, hands, and wrists.
Ability to crouch and stoop occasionally, and bend and twist the upper body and neck frequently.
Ability to lift or carry light to moderate objects, including luggage and a laptop, up to 15–20 pounds.
Regular and consistent attendance; varied hours may be required.

Nice To Haves

Oncology experience.
Candidates located in the San Francisco, California area or elsewhere on the West Coast.

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 duties as assigned.
Manage sites as prescribed in project plans.
Ensure study staff conducting the protocol receive the proper materials and instructions to safely enroll patients.
Verify that informed-consent procedures and protocol requirements are followed in accordance with applicable regulatory requirements.
Protect data integrity by carefully reviewing source documents and monitoring case report forms (CRFs) or other data-collection tools for missing or implausible data.
Manage registries 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.
Perform independent CRF review and generate and resolve queries using established data-review guidelines in 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.
Provide a high standard of care for clinical-trial participants and respond to emergency situations using clinical research standards.
Perform other duties as assigned by management.