In-house CRA I/ In-house CRA II

The role

This In-house CRA (IHCRA) role gives non-site-facing support to CRAs and clinical project teams across the study lifecycle. The work covers maintaining study documents and systems, reviewing site data, preparing metrics and completing agreed administrative follow-up.

What you will do

• Provide non-site-facing operational and administrative support to assigned CRAs and clinical project teams.
• Prepare and maintain Investigator Site Files and coordinate document distribution.
• Review Investigator Site Files remotely for completeness, where an electronic file is in use.
• Review documents for legibility, completeness and filing readiness, and file them in the eTMF.
• Review the eTMF for missing or expiring site documents and send follow-up lists to CRAs.
• Run scheduled reconciliations between the Delegation of Authority Log, CTMS, eTMF and system-access records.
• Set up and maintain site-level data, milestones and activities in CTMS and other study systems.
• Run reports and provide CRAs with agreed site metrics.
• Support sample tracking and vendor reconciliations, and report discrepancies to CRAs.
• Support audit and inspection readiness under CRA or CTM direction.

Required qualifications

• Bachelor's degree or international equivalent, or an equivalent combination of education and relevant experience.
• Initial experience in clinical research, clinical trial administration or study coordination in a CRO, pharmaceutical or biotechnology environment.
• Practical experience using CTMS, eTMF and other clinical trial systems or tools.
• Familiarity with ICH-GCP principles and clinical trial documentation.
• Strong written and verbal communication skills in English.
• Strong organization, prioritization and follow-through across multiple studies, sites and deadlines.
• High attention to detail for extended document and data review.
• Ability to identify discrepancies, communicate findings and escalate issues.
• Ability to work independently remotely while collaborating with CRAs, CTMs and cross-functional partners.
• Proficiency in Microsoft Outlook, Word, Excel and PowerPoint.
• Self-motivation, flexibility, teamwork and commitment to agreed responsibilities.

Nice to have

• Experience supporting multiple studies or countries in a centralized or regional clinical operations model.
• Experience with Veeva Clinical applications.

Benefits

• Extremely high retention rates compared to industry averages, as stated by the employer.

Before you apply

• Candidates must be legally authorized to work in the country of employment without employer sponsorship.
• Applications must be submitted in English.

About the company

Precision for Medicine is a clinical research organization focused on oncology and rare disease. The posting describes a strong culture and high employee retention.