Sr. CRA 2, FSP - Invitro Diagnostics - West Coast

FTINC Fortrea Inc.; North Carolina; On-site; USD 130,000 - 142,000; Full time

Job summary

Fortrea is seeking Sr. CRA 2s with 4+ years of monitoring experience for roles based on the West Coast US, remote-friendly. You will manage site monitoring, study file maintenance, and vendor liaison to ensure protocol adherence and data integrity.

Responsibilities include regulatory compliance, SAE reporting, CRF review, training of staff, and coordination of local projects. Travel of 50% overnight is required to support study sites.

Qualifications

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

Responsibilities

• Monitor study sites including routine visits, close-out, and file maintenance.
• Oversee site management per project plans and liaise with vendors.
• Ensure proper materials and instructions for site staff before protocol entry.
• Verify informed consent procedures and regulatory requirements.
• Maintain data integrity in CRFs and other data tools; monitor for gaps or implausible data.
• Conduct SAE reporting and follow-up; produce required narratives and reports.
• CRF review and query generation per data review guidelines.
• Assist with training of new staff; co-monitoring.
• Coordinate designated clinical projects as Local Project Coordinator.
• Perform other duties as assigned by management.

Skills

Clinical Monitoring

Travel readiness

Regulatory compliance

Education

University degree or allied health certification

Job description

Our FSP team is currently seeking Sr. CRA 2s with 4+ years of monitoring residing on the West Coast US!

What you will do

• 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.
• 50+% overnight travel.

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.

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: $130 - $142K #LI - Remote

Learn more about our EEO & Accommodations request here.

At Fortrea, we're all about turning the "impossible" into "I'm possible." Together, we break barriers to deliver exceptional service to our patients, fueled by a shared commitment to teamwork and excellence. Regardless of your role, we're all family, working together to achieve extraordinary results. At Fortrea, your career isn't just a job – it's a journey of making the exceptional possible, every day.