CRA 2

About the Role

Fortrea is seeking experienced CRA 2s to lead and support the Full Service Outsourcing team. Open to major hub locations within the US. Expect 60-70% travel and 8-10 site visits per month.

Key Responsibilities

• Responsible for all aspects of study site monitoring, including routine monitoring and close-out of clinical sites.
• Responsible for all aspects of site management as prescribed in project plans.
• Conduct pre-study and initiation visits; liaise with vendors.
• Ensure study staff have received proper materials and instructions to safely enter patients into the study.
• Ensure the protection of study patients by verifying adherence to informed consent procedures and protocol requirements according to applicable regulatory requirements.
• Ensure the 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 data.
• Responsible for all aspects of registry management as prescribed in project plans.
• Undertake feasibility work when requested.
• Complete Serious Adverse Event (SAE) reporting, process production of reports, narratives, and follow-up of SAEs.
• Independently perform CRF review, query generation, and resolution against established data review guidelines on Fortrea or client data management systems.
• Assist with training of new employees, e.g., co-monitoring.
• Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable).
• May act as a local client contact as assigned.
• Perform other duties as assigned by management.

Requirements & Tech Stack

• University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure).
• Clinical Monitoring experience: 6 months - 2 years.
• Comfortable working in a fast-paced environment where deviations from the study protocol are not allowed, and meeting timelines is critical for quality.
• Adaptable to changing priorities that require prioritization and on-the-spot adaptation.
• Teamwork and people skills are essential for smooth study operations.
• Technology-based environment; data is collected directly into an electronic environment.
• Open to various hub locations within the US.

Work Environment

• Work is performed in an office environment with exposure to electrical office equipment.
• Frequent travel to clients/site locations with occasional travel both domestic and international.
• Remote applications will be accepted on an ongoing basis.

Physical Requirements

• Ability to sit for extended periods and operate a vehicle safely.
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
• Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
• Ability to access and use a variety of computer software.
• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
• Regular and consistent attendance.
• Varied hours may be required.