Clinical Research Associate II, Phase I - Texas/Mid-West

FTINC Fortrea Inc.; Texas; Remote; USD 100,000 - 120,000; Full time

Job summary

Fortrea Inc. is seeking a Clinical Research Associate with at least 1 year of Clinical Monitoring experience and Phase I exposure.

The role involves site monitoring, study coordination, and ensuring regulatory compliance across multiple sites, with 40-50% overnight travel. Ideal candidates will have a university or allied health degree and be prepared for domestic travel, including to the Midwest, as described in the posting.

Qualifications

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

Responsibilities

• Monitor and manage all aspects of study site monitoring, including routine monitoring and close-out of clinical sites and maintenance of study files.
• Conduct pre-study and initiation visits and liaise with vendors.
• Ensure protection of study patients and adherence to regulatory requirements.
• Verify data integrity on Case Report Forms and other data collection tools.
• Assist with training of new employees and coordinate clinical projects as a Local Project Coordinator when assigned.
• Perform other duties as assigned by management.

Skills

Clinical Monitoring

Phase I experience

Education

University or college degree in allied health / nursing licensure

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 Texas or Mid-West (Kansas, Missouri, Nebraska, Iowa, Colorado).

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 monitoring.
• 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.

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: $100 - $120K

#LI - Remote Applications will be accepted on an ongoing basis.

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.