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

About the role

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). 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. The work environment is fast‑paced with constantly changing priorities, requiring strong teamwork and people skills, and is technology‑based with data collected directly into an electronic system. Physical requirements include the ability to sit for extended periods and operate a vehicle safely, repetitive hand movements, occasional crouching or stooping with frequent bending and twisting, ability to use various computer software, and light to moderate lifting (up to 15‑20 lbs). Regular and consistent attendance is expected, with varied hours possibly required.

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, liaison with vendors, and other duties as assigned.
• Responsible for all aspects of site management as prescribed in the project plans.
• Ensure study staff receive proper materials and instructions to safely enroll patients.
• Verify informed consent procedures and protocol adherence per applicable regulatory requirements to protect study patients.
• Ensure integrity of data submitted on CRFs or other collection tools by source document verification and monitoring for missing or implausible data.
• Manage registry aspects as prescribed in project plans, including undertaking feasibility work when requested.
• Complete Serious Adverse Event (SAE) reporting, produce reports and narratives, and follow up on SAEs.
• Independently perform CRF review, query generation, and resolution against established data review guidelines using 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.