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.

Sironax

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Clinical Trial Associate (CTA)