FSP - Sr. CRAs & CRA 1/2 - Ophthalmology

FTINC Fortrea Inc.; North Carolina; À distance; USD 110 000 - 145 000; Plein temps

Résumé du poste

Fortrea Inc. is seeking experienced CRAs with Ophthalmology monitoring experience to join our US FSP team. This role involves on-site monitoring, maintaining study files, initiating visits, and liaising with vendors. Regional travel is required and occasional travel outside the region may occur.

We are targeting Sr. CRAs as well as CRA 1s and 2s with 1–2 years of monitoring experience. Oncology and cardiology backgrounds are a plus.

Qualifications

• 4+ years of clinical monitoring experience for Sr. CRAs.
• Ophthalmology experience is required.
• 60-70% overnight travel.

Responsabilités

• Monitor study sites and manage routine monitoring and close-out activities.
• Ensure proper informed consent and protocol adherence.
• Prepare SAE reporting and data queries as needed.
• Coordinate with local project teams and vendors as assigned.

Connaissances

Ophthalmology monitoring

Clinical Monitoring

Regional travel

Formation

University degree or nursing licensure

Description du poste

Our FSP team is currently seeking experienced CRAs with Ophthalmology monitoring experience, major hub locations around the US will be considered. Regional travel with occasional outside travel at times. Oncology and cardiology experience also a plus. Seeking Sr. CRA level and CRA 1s and 2s (1-2 years of monitoring).

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 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, 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)
• 4+ years of Clinical Monitoring experience for Sr. CRAs
• Ophthalmology experience is required
• 60-70% overnight travel

We 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: $110 - $145K based on title #LI - Remote Applications will be accepted on an ongoing basis.

Learn more about our EEO & Accommodations request here.