Sr. Clinical Research Associate (Midwest and West Coast)

Location: United States – Midwest (TX) and West Coast. Work Arrangement: Field-based / Travel role – approximately 50–70% onsite at clinical trial sites; up to 70% travel required. Candidates must have no travel restrictions. Engagement Type: Contract, 12 months plus extension; full-time after a 3–4 week ramp-up.

About the role

The Clinical Research Associate (CRA) is responsible for monitoring and managing clinical trial sites to ensure compliance with study protocols, Good Clinical Practice (GCP), FDA regulations, and sponsor standards. This role supports study execution from site initiation through closeout while serving as a key point of contact for investigative sites and cross-functional study teams. This is a large-scale, multi-region clinical trial program offering the opportunity to work across a substantial CRA team supporting a high volume of active sites nationwide.

Responsibilities

• Conduct site monitoring visits, including site qualification, initiation, interim monitoring, and closeout activities.
• Ensure protocol compliance, data quality, and adherence to GCP and regulatory requirements.
• Serve as the primary point of contact for assigned investigative sites, communicating study updates, issues, and risks.
• Review and maintain essential study documentation, including Investigator Site Files and trial records.
• Prepare monitoring reports and escalate significant findings or site issues as appropriate.
• Track site performance, recruitment progress, and study milestones.
• Support investigator training, study meetings, and other clinical trial activities.
• Collaborate with internal teams, vendors, and site personnel to support successful study execution.

Requirements

• Minimum of 7 years of clinical monitoring experience within pharmaceutical, biotechnology, or CRO environments.
• Bachelor's degree in a scientific or healthcare-related field.
• Strong knowledge of clinical research operations, FDA regulations, ICH-GCP guidelines, and clinical trial conduct.
• Excellent organizational, communication, problem-solving, and relationship-management skills.
• Experience with CTMS, eTMF, eCRF platforms, and Microsoft Office applications.
• Ability to manage multiple priorities with minimal supervision in a fast-paced environment.
• Willingness and ability to travel up to 70%, with no travel restrictions.

Preferred Qualifications

• CNS (Central Nervous System) clinical trial experience.

Benefits

• 12-month contract with travel expenses covered.
• Large, active clinical trial program with multiple concurrent openings across the country.
• Opportunity to work across East, Central, and West regions with a sponsor known for repeat, long-term engagements.