In-house CRA I/II

Position Summary:

• Provides centralized, non-site-facing support to CRAs and clinical project teams across the study lifecycle.
• Supports consistent site oversight by maintaining study documentation and systems.
• Works in close collaboration with assigned CRAs and under the oversight of the CTM.

Essential Functions:

• Prepare and maintain Investigator Site Files, including document distribution and coordination.
• Review eTMF for completeness and identify documents requiring follow-up.
• Perform scheduled reconciliations between Delegation of Authority Log, CTMS, eTMF, and system-access records.

Qualifications:

• Bachelor’s degree in a scientific, healthcare, or related discipline.
• Initial experience in clinical research, clinical trial administration or study coordination within a CRO, pharmaceutical, or biotech environment.
• Practical experience using CTMS, eTMF, and other clinical trial systems.

Skills and Competencies:

• Strong organization, prioritization, and follow-through across multiple studies and deadlines.
• High attention to detail and ability to perform accurate document and data review.
• Ability to work independently in a remote environment while collaborating effectively with CRAs and CTMs.