FSP CRA 2 & Sr. CRA - Ophthalmology - Remote US

Fortrea; Durham (NC); Remote; USD 118.000 - 142.000; Vollzeit

Zusammenfassung

Fortrea is seeking experienced CRAs with 2+ years of monitoring experience and ophthalmology expertise. The role involves full-site monitoring, study file maintenance, and initiation visits, with 30-50% overnight travel across major hubs in the US.

You will ensure protocol compliance, data integrity, and SAE follow-up while coordinating with project teams. Ideal candidates hold a related allied health degree or certification and have demonstrated ability to work in a fast-paced, adaptive

Qualifikationen

• University or college degree, or certification in a related allied health profession.
• 3+ years of Clinical Monitoring experience
• 30-50+% overnight travel
• Ophthalmology experience required

Aufgaben

• 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 to safely enter patients into the study
• Ensure protection of study patients by verifying informed consent procedures and protocol adherence
• Ensure data integrity on CRFs and other data collection tools
• Responsible for registry management and feasibility work as requested
• Complete SAE reporting and follow-up
• Independently perform CRF review and query resolution
• Assist with training of new employees
• Coordinate designated clinical projects as Local Project Coordinator and may act as local client contact
• Perform other duties as assigned by management

Kenntnisse

Clinical Monitoring

Ophthalmology experience

Travel 30-50% overnight

Ausbildung

Bachelor or allied health certification

Jobbeschreibung

Our FSP team is currently seeking experienced CRAs with 2+ years of monitoring! Ophthalmology expertise required. Open to major hub locations in California, Texas, and the South East & 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 the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study
• Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements
• Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document 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 repo11s, 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 by management
• Assist with training of new employees, eg. co-monitoring
• Coordinate designated clinical projects as a Local Project Coordinator (with supervision, ifapplicable) 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)
• 3+ years of Clinical Monitoring experience
• 30-50+% overnight travel
• Ophthalmology experience

The important thing for us is you are comfortable working in an environment that is:

• Fast paced: where no deviations from the study protocol are allowed, and not meeting a timeline for even few minutes will create a quality issue.
• Changing priorities constantly asking you to prioritize and adapt on the spot.
• Teamwork and people skills are essential for the study to run smoothly.
• Technology based. We collect our data directly into an electronic environment.

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.
• Target Pay Range: $118-$142K based on title

#LI - Remote

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