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

Phase I team seeking a Clinical Research Associate with 1+ years of experience; ideal candidates have Phase I experience and reside in Texas or the Mid‑West (Kansas, Missouri, Nebraska, Iowa, Colorado).

Responsibilities

• Utilize skills, knowledge, and clinical judgement to provide a high standard of care for participants in clinical trials and respond to emergency situations based on 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 study staff have proper materials and instructions to safely enroll patients; verify informed consent procedures and protocol requirements; ensure data integrity on Case Report Forms (CRFs) or other collection tools; 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, produce 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 (with supervision, if applicable) and may act as a local client contact.
• 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.
• Ability to thrive in a fast‑paced environment with strict protocol adherence, changing priorities, teamwork, and technology‑based data collection.

Work Environment

• Office setting with exposure to electrical office equipment.
• Frequent travel to client/site locations; occasional domestic and international travel.

Physical Requirements

• Ability to sit for extended periods and operate a vehicle safely.
• Repetitive hand movements of both hands with fast, simple, repeated motions of fingers, hands, and wrists.
• Occasional crouching, stooping, frequent bending and twisting of the upper body and neck.
• Ability to access and use a variety of computer software (both in‑house and off‑the‑shelf).
• Light to moderate lifting and carrying of objects (including luggage and laptop) up to 15‑20 lb.
• Regular and consistent attendance; varied hours may be required.

Pay

Target Pay Range: $100 K – $120 K (Remote).