Job Description

Location: Waltham or Remote (U.S.)

Department: Clinical Operations

Reports To: VP of Clinical Operations

Position Summary

The Clinical Trial Associate (CTA) plays a critical role in the successful execution of Sironax clinical trials across Phase 1–3 programs. This individual supports end-to-end clinical operations, ensuring high-quality trial conduct, regulatory compliance, and operational excellence across global studies.

Key Responsibilities

• Support day-to-day execution of Phase 1–3 clinical trials
• Maintain clinical trial trackers and ensure visibility into study status
• Create and manage essential trial documents
• Perform eTMF quality reviews to ensure inspection readiness
• Assist in CRO and vendor oversight
• Review monitoring visit reports and track follow-up actions
• Conduct periodic EDC data reviews for quality and timeliness
• Support audits and regulatory inspections
• Coordinate meetings, agendas, and minutes
• Contribute to SOP development and process improvements

Qualifications

• Minimum of 3 years experience as a CTA with a Sponsor or CRO
• Knowledge of ICH-GCP and FDA regulations
• Strong organizational and communication skills
• Experience with EDC, CTMS, and eTMF systems
• Ability to work in fast-paced, global environment

Education

Bachelor’s degree required (Life Sciences related major preferred)

Travel

Infrequent, with the potential for 10–20% domestic and international travel based upon business needs

How to Apply:

If you meet the above criteria and are excited by the opportunity to join our team, please submit your application directly.

Please note: We are not accepting applications or outreach from recruitment agencies for this role. All candidates must apply directly.

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