Senior Clinical Research Associate

Barrington James; Denver (CO); On-site; USD 90,000 - 130,000; Full time

Job summary

Barrington James is seeking a Senior CRA for a small CRO, focused on US-only site monitoring activities. The role requires independence in on-site visits, initiation, routine monitoring, and close-out tasks in line with ICH-GCP and regulatory standards.

You will manage a defined caseload, ensure enrollment and data quality, and act as the primary liaison with investigators. Travel ~30% and mentoring junior staff are expected, with a dynamic, smaller infrastructure offering opportunities to shape

Qualifications

• Minimum 3–5 years' CRA experience with on-site monitoring.
• Strong knowledge of ICH-GCP and FDA/EMA regulations.
• Proven ability to manage a full monitoring caseload independently.
• Experience mentoring junior staff is a plus.
• Ability to travel ~30% for on-site visits (region-dependent).

Responsibilities

• Independently perform site selection, initiation, routine monitoring, and close-out visits per protocol, ICH-GCP, and regulations.
• Conduct remote and on-site monitoring visits with SDV, consent compliance, and data quality focus.
• Manage a defined caseload of sites with minimal supervision, ensuring enrollment and timelines.
• Serve as primary site contact, building relationships with investigators and site staff.
• Identify and resolve site-level issues, escalating risks to the Clinical Team Lead/PM as needed.
• Review and ensure completeness of essential documents/TMF per ICH-GCP and SOPs.
• Support development of monitoring plans, visit report templates, and site tools.
• Mentor junior CRA staff and CRA-in-training.
• Contribute to audit/inspection readiness at site and study level.
• Liaise with sponsors on site status, risk mitigation, and study progress.
• Support process improvements within a smaller CRO infrastructure.

Skills

Independent on-site monitoring

Excellent communication

Site relationship management

Autonomous work style

Travel willingness 30%

Education

Bachelor's degree in life sciences, nursing, or related field

Job description

New Role - Snr CRA - Small CRO - US Only

Key Responsibilities

• Independently perform site selection, initiation, routine monitoring, and close-out visits in accordance with the protocol, ICH-GCP, and applicable regulations
• Conduct/oversee remote and on-site monitoring visits, ensuring source data verification, informed consent compliance, and data quality
• Manage a defined caseload of sites with minimal supervision, ensuring enrollment, timelines, and quality metrics are met
• Serve as primary site contact, building strong relationships with investigators and site staff
• Identify and resolve site-level issues, escalating risks to the Clinical Team Lead/PM as appropriate
• Review and ensure completeness of essential documents/TMF in line with ICH-GCP and company SOPs
• Support development of monitoring plans, visit report templates, and site management tools
• Mentor and provide guidance to junior CRAs and CRA-in-training staff
• Contribute to audit/inspection readiness at site and study level
• Liaise directly with sponsors on site status, risk mitigation, and study progress as needed
• Support process improvement initiatives given the CRO's smaller, evolving infrastructure

Requirements

• Bachelor's degree in life sciences, nursing, or related field (or equivalent experience)
• Minimum 3–5 years' CRA experience, including independent on-site monitoring (CRO, sponsor, or site-based)
• Strong working knowledge of ICH-GCP, FDA/EMA (or relevant regional) regulations
• Proven track record managing a full monitoring visit caseload independently
• Experience in [therapeutic area, if relevant] preferred
• Excellent communication and site relationship management skills
• Ability to work autonomously in a smaller, less hierarchical company structure
• Willingness to travel 30% for on-site visits (region-dependent)
• Experience mentoring junior staff is a plus