Clinical Research Associate II (CRA 2)

Summary Of Responsibilities:

• Perform on-site monitoring visits including Initiation visits, Interim monitoring visits, and Close-Out visits
• Verify ICF and source data against CRFs per the Registry Monitoring Plan.
• Assess site compliance with protocol, GCP, and regulatory requirements.
• Review and collection of regulatory documents during on-site monitoring visits
• Provide on-site training and ongoing support to site staff on study procedures and documentation as needed and identified
• Identify/address and escalate protocol deviations, safety issues, and data queries and or discrepancies
• Support focused data collection activities when appropriate
• Maintain detailed visit reports and follow-up correspondence.
• Support audits and inspections by ensuring site readiness and providing necessary documentation and support.
• Maintain and use applicable trackers, tools and systems; participate in study team related meetings and training
• Maintain accurate and up-to-date records in clinical systems, including Clinical Trial Management Systems (CTMS) and electronic Trial Master File (eTMF), ensuring compliance with company procedures and regulatory requirements.

Qualifications (Minimum Required):

• Bachelor’s degree in life sciences or related field and or associated experience.
• 2+ years of on-site CRA experience, ideally in observational or rare disease studies.
• In-depth knowledge of clinical trial processes, GCP, and regulatory guidelines.
• Willingness to travel frequently to clinical sites/ up to 80%
• Strong interpersonal, training, and documentation skills.

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