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

Fortrea; United States; Remote; USD 100,000 - 120,000; Full time

Job summary

Fortrea is seeking a Clinical Research Associate with 1+ year of experience, preferably with Phase I exposure, to support monitoring activities in Texas or the Mid-West region (KS, MO, NE, IA, CO). The role involves site monitoring, data integrity, SAE reporting, and cross-functional collaboration.

Travel is 40–50% and the candidate should be comfortable working in a fast-paced, team-oriented, technology-driven environment. A University or allied health degree is required.

Qualifications

• Bachelor degree or allied health certification from an accredited institution.
• 1+ years of clinical monitoring experience.
• Phase I experience preferred.
• Willingness to travel 40–50%.

Responsibilities

• Monitor study sites from initiation to close-out; maintain study files and coordinate with vendors.
• Oversee site management per project plans.
• General on-site monitoring activities.
• Ensure staff have materials/instructions to safely enroll patients.
• Ensure informed consent and protocol adherence per regulatory requirements.
• Maintain data integrity for CRFs and data tools; monitor for missing data.
• Manage registry activities and feasibility as needed.
• Complete SAE reporting and follow-up.
• Independently review CRFs and resolve queries per guidelines.
• Assist with training of new employees.

Skills

Clinical monitoring

Phase I experience

Overnight travel

Teamwork

Education

Bachelor degree or allied health 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 Texas or Mid-West (Kansas, Missouri, Nebraska, Iowa, Colorado).

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.

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, ifapplicable) 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, 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

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