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

About the role

Our Phase I team is 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). The role involves utilizing skills, knowledge, and clinical judgement to provide a high standard of care for participants in clinical trials and respond to emergency situations per clinical research standards. 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. Physical requirements include sitting for extended periods, operating a vehicle safely, repetitive hand movements, occasional crouching/stooping, frequent bending/twisting, ability to access various computer software, light to moderate lifting up to 15‑20 lbs, regular attendance, and varied hours as needed.

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 study staff have proper materials and instructions to safely enroll patients; ensure protection of study patients by verifying informed consent procedures and protocol adherence per regulatory requirements; ensure integrity of data submitted on 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.
• 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.

Pay

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