Senior Clinical Research Associate

BioTalent; Maryland; On-site; USD 90,000 - 130,000; Full time

Job summary

BioTalent is seeking an experienced Senior Clinical Research Associate (CRA) to independently manage and monitor clinical trial sites across the full lifecycle, from start-up through close-out. This field-based role demands ownership and high standards of data quality, compliance, and site performance.

The ideal candidate has at least 5 years of CRA experience, strong knowledge of ICH-GCP and FDA regulations, and is comfortable traveling up to 100% to sites nationwide or internationally as

Qualifications

• Bachelor's degree in Life Sciences or related discipline.
• Minimum 5 years of CRA monitoring experience in clinical research.
• Experience independently managing sites across full trial lifecycle.
• Strong knowledge of ICH-GCP, FDA regulations, and study operations.
• Familiarity with eCRF/EDC systems.

Responsibilities

• Independently conduct Site Qualification Visits (SQVs).
• Conduct Site Initiation Visits (SIVs) and Interim Monitoring Visits (IMVs).
• Serve as primary contact for assigned trial sites.
• Ensure compliance with ICH-GCP, FDA regulations, and SOPs.
• Perform source data verification and resolve site queries.
• Manage Investigator Site Files (ISF) and TMF documentation.
• Oversee investigational product accountability and reconciliation.
• Provide ongoing site training and guidance throughout the study lifecycle.
• Complete monitoring reports and visit documentation within timelines.
• Identify and escalate site issues and compliance risks.

Skills

ICH-GCP

FDA regulations

eCRF / EDC systems

Multi-site management

Travel readiness

Education

Bachelor's degree in Life Sciences or related discipline

Tools

EDC systems

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, elevate, 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.