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Clinical Trial Associate (CTA)

Sironax

Waltham, MAOnsitePosted 25 days ago
Full TimeMid LevelClinical DevelopmentBiotechnology
Original posting ↗

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.

Job description

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

Requirements

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

Company overview

Sironax is a global clinical-stage biotechnology company founded in 2017 and headquartered in Beijing, China, with a growing presence in the United States. The company develops transformative therapies for neurodegenerative, inflammatory, immunologic, metabolic, and rare diseases by targeting fundamental pathways of tissue degeneration. Leveraging expertise in programmed cell death, medicinal chemistry, translational medicine, and global clinical trial execution, Sironax advances small-molecule drug candidates, cell death inhibitors, and targeted anti-inflammatory therapeutics. Its pipeline includes SARM1 and RIP1 modulators and PDE3A/SLFN12 disruptors, reflecting a strong intellectual property portfolio of over 100 patent documents. Sironax has raised approximately $376 million across multiple funding rounds, including a Series B1 in 2024, backed by investors such as the Abu Dhabi Investment Authority and CBC Group. With roughly 150-170 employees, the company is recognized as a rising leader in China's neurology-focused biotech sector.

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