FSP Sr. Clinical Research Associate II - East Coast / North East - Ophthalmology

About the role

Our FSP team is seeking Ophthalmology Sr. CRAs with 4+ years of monitoring experience, residing in the North East US.

What You Will Do

You will utilize your skills, knowledge, and clinical judgement to provide a high standard of care for participants in clinical trials and respond to emergency situations based upon clinical research standards.

Responsibilities

• Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre‑study and initiation visits; liaise with vendors; and other duties as assigned.
• Responsible for all aspects of site management as prescribed in the project plans.
• General On‑Site Monitoring: ensure study staff have proper materials and instructions to safely enroll patients; protect study patients by verifying informed consent procedures and protocol adherence per regulatory requirements; ensure integrity of data submitted on CRFs or other collection tools by source document verification; monitor data for missing or implausible data.
• Responsible for all aspects of registry management as prescribed in the 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 as assigned.
• Assist with training of new employees, e.g., co‑monitoring.
• Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable) and may act as a local client contact as assigned.
• Perform other duties as assigned by management.

Requirements

• University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure).
• 5+ years of Clinical Monitoring experience.
• Oncology experience, early phase preferred.
• 30‑50% overnight travel.

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.

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 developed both in‑house and off‑the‑shelf.
• 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.

Pay

Target Pay Range: $125 - $142K - Remote