FSP Sr. CRA - Ophthalmology - Remote US

Fortrea•Durham, NC

6d•Remote

About The Position

The FSP Senior Clinical Research Associate (CRA) supports ophthalmology clinical trials by providing site monitoring and management. The role applies clinical research knowledge and judgment to support participant safety, adherence to protocols and regulatory requirements, and the integrity of study data. It includes frequent travel to client and site locations, including overnight travel, and may involve domestic and international travel. The position operates in a fast-paced, technology-based environment where priorities may change and protocol adherence and timelines are important. Work is performed in an office environment as well as at clinical sites. Varied hours may be required.

Requirements

University or college degree, or certification in a related allied health profession from an appropriately accredited institution (for example, nursing licensure).
At least 3 years of clinical monitoring experience.
Ophthalmology experience.
Ability to travel overnight 30–50% or more.
Comfort working in a fast-paced, changing-priority, team-oriented, technology-based environment.
Ability to sit for extended periods and operate a vehicle safely.
Ability to perform repetitive hand movements and access and use various computer software.
Ability to occasionally crouch and stoop and frequently bend and twist the upper body and neck.
Ability to lift and carry light to moderate objects, including luggage and a laptop, up to 15–20 lbs.
Regular and consistent attendance.

Responsibilities

Conduct all aspects of study site monitoring, including routine monitoring and site close-out, maintaining study files, and conducting pre-study and initiation visits.
Manage sites as prescribed in project plans and liaise with vendors.
Ensure study staff receive the materials and instructions needed to conduct the protocol safely.
Verify informed consent procedures and protocol requirements are followed in accordance with applicable regulatory requirements.
Protect data integrity by reviewing source documents and Case Report Forms (CRFs) or other data collection tools, and monitoring for missing or implausible data.
Manage registries as prescribed in project plans and undertake feasibility work when requested.
Complete Serious Adverse Event (SAE) reporting, including report production, narratives, and follow-up.
Independently review CRFs and generate and resolve queries using established data review guidelines and 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 act as a local client contact when assigned.
Perform other duties as assigned by management.