Inhouse Clinical Research Associate

In-House Clinical Research Associate (CRA)

Seeking a proactive, detail-oriented In-House CRA to support early- and late-phase clinical trials in a fast-paced biotech setting. This role is central to study operations, vendor oversight, and ensuring quality and compliance from start-up through close-out.

Key Responsibilities

• Manage site feasibility, selection, start-up, and close-out documentation.
• Maintain CTMS and study trackers to monitor site activation, enrollment, and performance metrics.
• Support remote site monitoring, review reports and ICFs, and track resolution of issues with field CRAs.
• Serve as point of contact for select vendors, review reports for accuracy, and track performance.
• Maintain eTMF to inspection readiness and support cross-functional study communication.

Qualifications

• Bachelor’s in life sciences (or related field) preferred;
  Associate’s with relevant experience considered.
• 1–3 years’ clinical research experience, ideally in biotech or sponsor settings.
• Knowledge of GCP, ICH, and regulatory requirements.
• Proficiency with Veeva Vault, EDC, IRT, CTMS, and Microsoft Office.
• Strong organizational, communication, and problem-solving skills.
• Willingness to travel domestically up to 20%.