Clinical Research Associate II, Phase I - Florida

FTCRUMAD Fortrea Clinical Research Unit Inc.; Daytona Beach (FL); On-site; USD 105,000 - 118,000; Full time

Job summary

Fortrea Clinical Research Unit Inc. in Florida is seeking a Clinical Research Associate with 1+ year of monitoring experience, preferably in Phase I, to join our Phase I team.

You will conduct site monitoring, ensure data integrity, and support pre-study and initiation visits while liaising with vendors and study staff. Travel 40-50% is required as you coordinate with multiple sites in the region and contribute to site management per project plans, maintaining regulatory compliance and

Qualifications

• 1+ years of Clinical Monitoring experience.
• Phase I experience preferred.
• Residence in Florida or nearby for on-site duties.
• University or college degree, or certification in an allied health field.

Responsibilities

• Monitor sites for protocol compliance and data quality at all visits.
• Perform pre-study and initiation visits; maintain study files and CRFs.
• Coordinate with vendors and project team; assist in SAE reporting and data queries.
• Assist with training of new staff and act as local project contact as needed.
• Support site management activities as prescribed by the project plans.

Skills

Clinical Monitoring

Phase I experience

Site monitoring

On-site coordination

Data integrity

Education

Allied health degree certification

Job description

Our Phase I team is currently seeking a Clinical Research Associate with 1+ years of experience. Ideal candidates would have phase I experience and reside in the Florida.

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). 1+ years of Clinical Monitoring experience. Phase I experience. 40-50% overnight travel.

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 #LI

Company Culture

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.