Senior Clinical Research Associate

BioTalent; Utah; On-site; USD 90,000 - 120,000; Full time

Job summary

BioTalent seeks an experienced Senior Clinical Research Associate (CRA) to independently manage and monitor clinical trial sites across the full study lifecycle, from start-up through close-out. This field-based role requires strong ownership of site activities with minimal supervision, while ensuring compliance, data quality, and site performance.

You will conduct SQVs, SIVs, IMVs, and COVs, serve as the primary site contact, ensure adherence to ICH-GCP and FDA regulations, perform SDV, and

Qualifications

• Bachelor's degree in Life Sciences or related field.
• Minimum 5 years CRA monitoring experience.
• Experience across full clinical lifecycle.
• Ability to travel up to 100%.

Responsibilities

• Conduct Site Qualification Visits (SQVs) and Site Initiation Visits (SIVs).
• Perform Interim Monitoring Visits (IMVs) and Close-Out Visits (COVs).
• Serve as primary contact for assigned sites and ensure compliance with study protocols.
• Ensure adherence to ICH-GCP, FDA regulations, and SOPs.
• Perform source data verification and maintain data integrity.
• Manage Investigator Site Files (ISF) and TMF documentation; maintain inspection readiness.
• Provide ongoing site training and support; address compliance risks.
• Prepare monitoring reports and visit documentation within required timelines.

Skills

CRA monitoring

Site management

Regulatory compliance

Travel readiness

Education

Bachelor's in Life Sciences

Tools

eCRF/EDC

Job description

We are seeking an experienced Senior Clinical Research Associate (CRA) to independently manage and monitor clinical trial sites throughout the full study lifecycle, from start-up through close-out. This is a highly autonomous, field-based role requiring an experienced monitor who can take ownership of site activities with minimal supervision while ensuring the highest standards of compliance, data quality, and site performance.

Key Responsibilities

Independently conduct:

• Site Qualification Visits (SQVs)
• Site Initiation Visits (SIVs)
• Interim Monitoring Visits (IMVs)
• Close-Out Visits (COVs)
• Serve as the primary point of contact for assigned clinical trial sites.
• Ensure compliance with study protocols, ICH-GCP, FDA regulations, and applicable SOPs.
• Perform source data verification, resolve site queries, and maintain data integrity and quality.
• Manage Investigator Site Files (ISF) and support Trial Master File (TMF) documentation to maintain inspection readiness.
• Conduct investigational product accountability and reconciliation activities.
• Provide ongoing site training, support, and guidance throughout the study lifecycle.
• Complete monitoring reports, follow-up letters, and visit documentation within required timelines.
• Identify, escalation, and support resolution of site issues and compliance risks.

Requirements

• Bachelor's degree in Life Sciences or a related scientific discipline.
• Minimum 5 years of CRA monitoring experience within clinical research.
• Proven experience independently managing sites across the full clinical trial lifecycle.
• Strong knowledge of:
• ICH-GCP
• FDA regulations
• Clinical trial operations
• eCRF and electronic data capture systems
• Demonstrated ability to manage multiple sites and priorities simultaneously.
• Valid driver's licence required.
• Up to 100% travel required, including air and ground travel.