FSP Sr. Clinical Research Associate II - Northeast - Ophthalmology

Fortrea•Durham, NC

7d•Remote

About The Position

The FSP Sr. Clinical Research Associate II supports clinical research studies in the Northeast, with an Ophthalmology focus. The role uses clinical research knowledge and judgment to support participant safety and respond to emergency situations according to clinical research standards. It involves comprehensive site monitoring and management, registry management, data review, safety reporting, and coordination with study sites, vendors, clients, and colleagues. The role is performed in an office environment and includes frequent travel to client and site locations, with occasional domestic and international travel. Varied hours may be required.

Requirements

University or college degree, or certification in a related allied health profession from an appropriately accredited institution, such as nursing licensure.
5+ years of Clinical Monitoring experience.
Comfort working in a fast-paced environment with strict protocol and timeline requirements, frequently changing priorities, and a need to prioritize and adapt quickly.
Teamwork and people skills.
Comfort working in a technology-based environment where data are collected electronically.
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 occasionally crouch and stoop, and frequently bend and twist the upper body and neck.
Ability to access and use a variety of in-house and off-the-shelf computer software.
Ability to lift and carry light to moderate objects, including luggage and a laptop, up to 15–20 lbs.
Regular and consistent attendance.

Nice To Haves

Ophthalmology or Oncology experience.
Oncology experience, with early-phase experience preferred.

Responsibilities

Perform all aspects of study site monitoring, including routine monitoring and site close-out, maintaining study files, and conducting pre-study and initiation visits.
Liaise with vendors and perform other assigned duties.
Manage sites as prescribed in project plans.
Ensure study staff have the materials and instructions needed to conduct the protocol and enroll participants safely.
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 submitted Case Report Forms (CRFs) or other data collection tools.
Monitor data for missing or implausible entries.
Manage registries as prescribed in project plans.
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 and assigned Fortrea or client data management systems.
Assist with training new employees, including co-monitoring.
Coordinate designated clinical projects as a Local Project Coordinator, with supervision if applicable, and serve as a local client contact when assigned.
Perform other duties as assigned by management.