FSP Sr. CRA - Ophthalmology - Remote US

Fortrea; Seattle (WA); Remote; USD 130.000 - 142.000; Vollzeit

Zusammenfassung

Fortrea is seeking an experienced Senior CRA with ophthalmology monitoring expertise to join our FSP team. The role requires 3+ years of clinical monitoring experience and 30-50% overnight travel across major hub locations in CA, TX, and the US East and South regions.

Responsibilities include on-site monitoring, study file maintenance, regulatory compliance, data quality checks, SAE processing, and potential local project coordination.

Qualifikationen

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

Aufgaben

• Oversee all aspects of site monitoring: routine monitoring, site close-out, study file maintenance, and initiation visits; liaise with vendors.
• Ensure proper entry of patients into the protocol and adherence to regulatory requirements during visits.
• Verify informed consent procedures and protocol requirements.
• Monitor data quality in CRFs or other data collection tools and query resolution.
• Manage registry activities and perform feasibility work when required.
• Complete SAE reporting and follow-up with narratives and reconciliation.
• CRF review and data review guidance adherence per project standards.
• Support training of new staff and co-monitoring when needed.
• Coordinate clinical projects as Local Project Coordinator and serve as local client contact if assigned.

Kenntnisse

Clinical Monitoring

Ophthalmology experience

Study coordination

Ausbildung

Bachelor's degree or allied health certification

Jobbeschreibung

Our FSP team is currently seeking experienced Sr. CRAs with 3+ 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

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 MonitoringEnsure 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 repos, 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, 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)
• 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.

Salary

• Target Pay Range: $130 - $142K

#LI - Remote

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