FSP Sr. Clinical Research Associate II - Northeast - Ophthalmology

Fortrea•New York, VT

8d•$125,000 - $142,000•Remote

About The Position

The Senior Clinical Research Associate II will monitor and manage clinical research sites and support study conduct, with a focus on ophthalmology or oncology studies. The role involves applying clinical research knowledge and judgment to help protect trial participants, maintain study quality, and respond to emergency situations according to clinical research standards. The position is listed as remote and requires frequent travel to client and site locations, including 30–50% overnight travel. The role includes routine and close-out monitoring, pre-study and initiation visits, site and registry management, maintenance of study files, and coordination with vendors and study teams. The Senior CRA also verifies that study staff have the necessary materials and instructions, ensures informed-consent procedures and protocol requirements are followed, and reviews source documents and study data for accuracy and completeness. Additional duties include SAE reporting and follow-up, CRF review and query resolution, supporting new-employee training, and potentially coordinating local clinical projects. Work is performed in an office environment with exposure to electrical office equipment, alongside frequent domestic and international travel. The environment is fast-paced, technology-based, and requires adaptability, attention to timelines and protocol compliance, and effective teamwork. 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 5 years of clinical monitoring experience.
Comfort working in a fast-paced environment with strict protocol and timeline requirements.
Ability to adapt and reprioritize as priorities change.
Teamwork and people skills.
Comfort working in a technology-based environment where data is collected electronically.
Ability to travel overnight 30–50% of the time.
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 crouch or stoop occasionally and bend and twist the upper body and neck frequently.
Ability to access and use various in-house and off-the-shelf computer software.
Ability to lift and carry, or otherwise move, light to moderate objects such as luggage and a laptop, with a maximum lift of 15–20 lbs.
Regular and consistent attendance.

Nice To Haves

Oncology experience; early-phase experience preferred.

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 study sites as prescribed in project plans.
Conduct general on-site monitoring.
Ensure study staff conducting the protocol receive the materials and instructions needed to enroll patients safely.
Protect study participants by verifying compliance with informed-consent procedures, protocol requirements, and applicable regulatory requirements.
Verify the integrity of data submitted on Case Report Forms (CRFs) and other data collection tools through careful source-document review, and monitor 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 according to established data-review guidelines in 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 where applicable, and potentially act as a local client contact when assigned.
Perform other duties as assigned by management.