Senior CRA 2, FSP – Invitro Diagnostics

Senior CRA 2, FSP - Invitro Diagnostics
Lifelancer
United States (nationwide) (nationwide) (On-site)

About the Role

The Sr. CRA 2 role at Lifelancer involves critical responsibilities in clinical trial monitoring and management. This position requires a high level of expertise, ensuring compliance with regulatory standards and maintaining the integrity of study data.

• Responsible for routine and close-out site monitoring, including pre-study and initiation visits
• Maintain study files and liaise with vendors as necessary
• Ensure proper materials and instructions are provided to protocol staff
• Verify informed consent procedures and adherence to regulatory requirements
• Monitor data for missing or implausible entries on Case Report Forms (CRFs)
• Undertake feasibility work when requested, including SAE reporting and production of reports/narratives
• Independently perform CRF review and query generation/resolution against established guidelines

Key Responsibilities

You will be responsible for all aspects of study site monitoring, registry management, and on-site general oversight. This includes ensuring the safety and rights of participants, maintaining data integrity, and performing various administrative tasks as assigned.

• Ensure proper materials and instructions are provided to protocol staff
• Verify informed consent procedures and adherence to regulatory requirements
• Monitor data for missing or implausible entries on Case Report Forms (CRFs)
• Undertake feasibility work when requested, including SAE reporting and production of reports/narratives
• Independently perform CRF review and query generation/resolution against established guidelines

What You Bring

Candidates should have a minimum of 4+ years of experience in clinical research, with specific expertise in monitoring. A strong background in clinical trial management, data integrity, and regulatory compliance is essential.

• Minimum of 4+ years of experience in clinical research
• Experience in site monitoring, CRF review, and query resolution
• Familiarity with regulatory requirements and standards
• Strong organizational and communication skills
• A proven track record of ensuring data integrity and compliance

About the Company

Lifelancer is a leading provider in clinical research, dedicated to advancing medical science through high-quality clinical trials. Our team is committed to excellence and innovation in healthcare.

Next Steps

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