Clinical Research Associate II, Phase I

FTCRUMAD Fortrea Clinical Research Unit Inc.; North Carolina; Remote; USD 105,000 - 118,000; Full time

Job summary

Fortrea Clinical Research Unit Inc. is seeking a Clinical Research Associate II with 1+ years of on‑site monitoring experience. The role focuses on site monitoring, data integrity, and adherence to protocols in Phase I trials, with 40–50% overnight travel and potential remote work in the U.S.

Responsibilities include site management, regulatory compliance, SAE reporting, and collaboration with study teams. Strong clinical judgment and teamwork are essential in this fast‑paced environment.

Qualifications

• 1+ years of clinical monitoring experience.
• Phase I trial experience preferred.
• Overnight travel 40–50% is required.

Responsibilities

• Monitor clinical sites including routine monitoring and close‑out.
• Maintain study files and CRFs; ensure data integrity.
• Coordinate pre‑study and initiation visits with vendors.
• Ensure informed consent procedures and protocol adherence.
• Support training and local project coordination as needed.

Skills

Clinical Monitoring

Phase I experience

Travel readiness

Education

Healthcare degree or certification

Job description

Our Phase I team is currently seeking a Clinical Research Associate II with 1+ years of on‑site monitoring experience. Ideal candidates would have phase I experience and reside within the U.S.

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.

• 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 reports, 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, e.g. 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)
• 1+ years of Clinical Monitoring experience
• Phase I experience
• 40‑50% 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, changing priorities constantly, and requires 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: $105 - $118K

Remote

Learn more about our EEO & Accommodations request.

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.