Clinical Trial Operations Specialist

Januxrx; San Diego (CA); Hybrid; USD 65,000 - 90,000; Full time

Benefits offered by this job

Annual bonus program

Incentive stock option plan

401k plan with employer contribution

Medical, dental, and vision insurance

Job summary

Janux Therapeutics, Inc. is seeking a Clinical Trial Associate (CTA) to support planning, execution, and closeout of clinical studies across our development programs.

You will coordinate TMFs, study trackers, regulatory documents, and vendor activities, ensuring ICH/GCP compliance and alignment with internal SOPs. You will partner with Clinical Trial Managers, CROs, sites, and cross-functional teams to ensure timely, inspection-ready trials.

Qualifications

• Bachelor's degree in Life Sciences, Nursing, Public Health, or a related scientific discipline.
• 2+ years of clinical research experience in a pharmaceutical or biotechnology setting.
• Experience supporting Phase I-IV clinical trials.

Responsibilities

• Support the day-to-day execution of clinical trials from study start-up through closeout.
• Assist Clinical Trial Managers with operational study activities and project coordination.
• Coordinate study team meetings, prepare agendas, document meeting minutes, and ensure follow-up on action items.
• Maintain study trackers, timelines, enrollment reports, and operational dashboards.
• Assist with site onboarding and activation activities.
• Support management of CROs, vendors, and study-related deliverables.
• Maintain electronic Trial Master Files (eTMFs) to ensure completeness, quality, and inspection readiness.
• Conduct routine TMF reviews and reconcile missing or incomplete documents with CROs and study vendors.
• Assist with collection, review, filing, and archiving of essential trial documents.
• Maintain study-specific filing systems and operational documentation.
• Support study start-up activities including vendor onboarding, site activation, investigator meetings, and study system setup.
• Assist with review and distribution of study materials, informed consent documents, and study tools.
• Coordinate clinical trial supplies, equipment shipments, and study-related materials.
• Track regulatory submissions, site essential documents, and study milestones.
• Serve as an operational point of contact for clinical sites, CROs, and other external partners.
• Facilitate communication between internal teams and external stakeholders.
• Track site and vendor inquiries and route issues to appropriate team members.
• Assist with scheduling vendor meetings and maintaining documentation of vendor performance activities.
• Ensure clinical trial activities are conducted in accordance with ICH/GCP guidelines, applicable regulations, and internal SOPs.
• Support audit and inspection readiness activities.
• Assist with quality review of study documentation and study-level processes.
• Participate in process improvement initiatives across Clinical Operations.
• Support study closeout activities, including TMF reconciliation, site document collection, and archiving activities.
• Assist with drug accountability reconciliation and study documentation required for Clinical Study Reports (CSRs).
• Perform other duties as assigned.

Skills

Attention to detail

Organizational skills

Communication skills

Cross-functional collaboration

Independent worker

Education

Bachelor's degree in Life Sciences, Nursing, Public Health, or related discipline

Tools

eTMF

CTMS

EDC

IRT

Job description

Janux Therapeutics, Inc. is seeking a Clinical Trial Associate (CTA) to support planning, execution, and closeout of clinical studies across our development programs.

You will coordinate TMFs, study trackers, regulatory documents, and vendor activities, ensuring ICH/GCP compliance and alignment with internal SOPs. You will partner with Clinical Trial Managers, CROs, sites, and cross-functional teams to ensure timely, inspection-ready trials.