Regional CRA, Early Development (60% Travel)

ICON plc; Bell (CA); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Annual leave

Health insurance

Retirement planning

Global EAP/LifeWorks

Life assurance

Flexible benefits

Job summary

ICON Strategic Solutions seeks a Clinical Research Associate for regional on-site monitoring in early development multi-therapeutic trials. You will serve as the main liaison between sites and sponsors, perform site visits, ensure ICH-GCP compliance, and maintain CTMS/eTMF documentation across programs.

The role requires a 2+ year on-site monitoring background in pharma or CRO, strong communication, and willingness to travel up to 60% regionally.

Qualifications

• Minimum 2+ years of on-site monitoring experience in pharma or CRO.
• Experience in early development Phase I/II trials across multiple therapeutic areas.
• Proficient in ICH-GCP, local regulatory requirements and clinical systems such as CTMS and eTMF.
• Strong communication, problem solving and collaborative skills.

Responsibilities

• Serve as primary point of contact between investigation sites and sponsor for early development trials.
• Conduct site visits: selection, initiation, routine monitoring, and close-out.
• Ensure site compliance with ICH-GCP, SOPs, and regulations.
• Maintain up-to-date documentation in CTMS and eTMF.
• Support and track site staff training and compliance records.
• Monitor patient safety with timely AE/SAE/PQC reporting.
• Support site recruitment and retention efforts.
• Oversee drug accountability and storage, return, or destruction.
• Resolve data queries and drive timely data entry.
• Document site progress and escalate risks or issues to the clinical team.
• Assist in tracking site budgets and site payments.
• Collaborate with cross-functional partners (CTAs, LTMs, CTMs).

Skills

Communication skills

Team player

Problem-solving

Education

Bachelor’s degree in Life Sciences or RN

Tools

CTMS

eTMF

Job description

ICON Strategic Solutions seeks a Clinical Research Associate for regional on-site monitoring in early development multi-therapeutic trials. You will serve as the main liaison between sites and sponsors, perform site visits, ensure ICH-GCP compliance, and maintain CTMS/eTMF documentation across programs.

The role requires a 2+ year on-site monitoring background in pharma or CRO, strong communication, and willingness to travel up to 60% regionally.