Magnit Global is a leading, global professional services and technology company and a certified "Great Place to Work". We have been a leader in contingent workforce management since 1991 and work with leading Fortune 500 companies and other large organizations across numerous verticals including consumer electronics, research and development, pharmaceuticals, health services, and many more!

We're glad to continue a relationship with you and happy to assist in the next steps of your career once more!

This contract opportunity is with Insmed.

About the Role

Seeking an experienced Sr. CRA to provide hands-on monitoring and data-readiness support for an active, sponsor-led Phase 1 gene therapy study approaching an interim data freeze.

What You'll Do

• Perform data cleaning and monitoring of gene therapy clinical studies for adherence to protocol, ICH/GCP, SOPs, and Clinical Monitoring Plan.
• Conduct on-site and remote visits, create trip reports in Veeva, and monitor site performance metrics.
• Ensure quality of data generated from clinical sites and resolve subject eligibility/protocol deviation issues.
• Collaborate with CTM/Data Management lead/COL to follow up on issues and ensure timely resolution.
• Track essential documents, review/approve site ICFs, and coordinate activities with third-party vendors.
• Monitor metrics, study status, query tracking, non-compliance, and protocol deviations.
• Perform senior-level independent monitoring, including PSV/SIV/IMV/COV.
• Review regulatory binders/ISF and reconcile documentation.
• Identify, document, and follow up on protocol deviations and site issues.
• Manage site relationships, particularly with academic/rare-disease sites.
• Review investigational product/gene therapy administration documentation.
• Travel immediately and frequently for on-site monitoring as needed.

What You'll Bring

• Proficiency in Veeva Vault, including eTMF/CTMS and monitoring documentation.
• Experience with gene therapy/rare disease clinical trials and complex early-phase (Phase 1/2) trials.
• Proficiency in EDC systems, ideally Medidata Rave.
• Strong written monitoring reports and action-item follow-up skills.
• Ability to independently prioritize high-volume outstanding SDV and close monitoring gaps.
• Minimal onboarding required and ability to become productive quickly.

Preferred Qualifications

• Bachelor’s or Master's degree in life sciences, nursing, healthcare, or related field preferred.
• Equivalent combination of education and relevant clinical research experience considered.
• ACRP or SOCRA certification preferred, but not required.

This is the pay range that Magnit reasonably expects to pay for this position: $73.44/hour - $73.44/hour.

Benefits: Medical, Dental, Vision, 401K