Clinical Trial Associate (CTA) Job at Sironax, Waltham, MA

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  • Sironax
  • Waltham, MA

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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