Clinical Research Associate

Clinical Research Associate (CRA) / Monitor (Up to 60% travel)

The Clinical Research Associate (CRA) is responsible for supporting clinical activities across domestic and international studies. This role ensures high‑quality study execution, compliance with regulatory requirements, and effective collaboration with clinical sites and internal teams. The CRA may also support additional clinical initiatives as needed.

• Conduct site qualification and site initiation visits to assess site readiness and regulatory compliance.
• Perform routine monitoring visits to ensure protocol adherence, accurate data collection, and proper reporting.
• Conduct site close‑out visits and verify that all site files are complete, accurate, and up to date.
• Train site staff on protocol requirements, source documentation, and case report form (CRF) completion.

• Collaborate with Senior CRAs to develop source documentation and CRFs aligned with protocol requirements.
• Support sites and internal teams in developing site‑specific consent/assent language and IRB submissions.
• Maintain real‑time filing of site documents to ensure Trial Master File (TMF) accuracy and completeness.
• Ensure compliance with SOPs, local regulations, ICH guidelines, and GCP standards.

• Provide study‑specific information and support validation activities for clinical study reports.
• Participate in team meetings, document meeting minutes, and track action items.
• Work closely with internal and external stakeholders to support study progress and resolve issues.

• Perform other tasks as required, depending on study needs and team structure.

• Bachelor’s degree (B.S. or B.A.) or equivalent combination of education and experience.
• Minimum of 3 years of experience in clinical research study execution.
• Ability to travel up to 60%, often on short notice, and independently manage travel schedules.
• Strong analytical skills, attention to detail, and interpersonal communication abilities.
• Knowledge of regulatory agency guidelines and clinical research requirements.
• Strong written and verbal communication skills.
• Ability to communicate effectively at all organizational levels.
• Proficiency with PC applications: word processing, spreadsheets, databases, and internet research.
• Flexible and comfortable working in a fast‑paced environment.
• Strong organizational skills and ability to prioritize effectively.
• Team‑oriented mindset with the ability to maintain accurate and thorough records.

• Mid‑Senior level

• Contract

• Research
• Medical Equipment Manufacturing