Clinical Research Associate II, Phase - Dallas, TX

Our Phase I team is currently seeking a Clinical Research Associate with 1+ year of experience. Ideal candidates should have Phase I experience and reside in the Midwest, preferably Dallas, Texas.

• 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 protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to applicable regulatory requirements.
• Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review; monitor data for missing or implausible entries.
• 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; generate and resolve queries against established data review guidelines on Fortrea or client data management systems.
• Assist with training of new employees, e.g., co‑monitoring.
• Coordinate designated clinical projects as a Local Project Coordinator and may act as a local client contact as assigned.
• Perform other duties as assigned by management.

• University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure).
• At least 1 year of clinical monitoring experience.
• Phase I experience.
• Ability to travel overnight 40–50% of the time.

Work is performed in an office environment with exposure to electrical office equipment. Frequent travel to client/site locations with occasional domestic and international travel.

• 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 the 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 moving) 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: $105,000–$118,000 per year.

We are an equal opportunity employer. We comply with all applicable federal, state, and local laws and regulations regarding non‑discrimination in employment. Accommodations have been made for qualified individuals with disabilities and veteran status.