Hybrid Clinical Trial Operations Specialist

Janux Therapeutics, Inc.; California (MO); Hybrid; USD 105,000 - 115,000; Full time

Benefits offered by this job

Annual bonus

Stock options

401k plan

Medical insurance

Dental insurance

Vision insurance

HSA/FSA

Unlimited PTO

Holiday schedule

Relocation assistance

Job summary

Janux Therapeutics, Inc. is seeking a Clinical Trial Associate (CTA) to provide operational support across our clinical development programs in a fast-paced biotech environment.

You will collaborate with Clinical Trial Managers, CROs, and study sites to ensure trials adhere to ICH/GCP, regulation, and SOPs while maintaining inspection-ready TMFs. The role emphasizes meticulous documentation, study trackers, site onboarding, and cross-functional communication, with a path to grow within a dynamic

Qualifications

• Bachelor's degree in a life sciences field is required.
• 2+ years in clinical research in pharma/biotech.
• Experience supporting Phase I–IV trials.
• Familiarity with ICH/GCP guidelines.
• Knowledge of TMF/eTMF and related systems.
• Strong organizational skills and attention to detail.

Responsibilities

• Support day-to-day execution of clinical trials from start-up through closeout.
• Assist Clinical Trial Managers with operational study activities.
• Coordinate study team meetings, agendas, minutes, and action items follow-up.
• Maintain study trackers, timelines, enrollment reports, and dashboards.
• Assist with site onboarding and activation activities.
• Manage CROs, vendors, and study-related deliverables.
• Maintain eTMFs ensuring completeness and inspection readiness.
• Reconcile missing documents with CROs/vendors.
• Assist with collection, filing, and archiving of essential trial documents.
• Maintain study-specific filing systems and documentation.
• Support study start-up activities including vendor onboarding and site activation.
• Review and distribute study materials and informed consent documents.
• Coordinate supplies, shipments, and materials.
• Track regulatory submissions and study milestones.
• Serve as operational contact for sites and external partners.
• Facilitate cross-functional communication and issue escalation.
• Support audit and inspection readiness, quality reviews, and process improvements.
• Participate in closeout activities including TMF reconciliation and CSR documentation.
• Perform other duties as assigned.

Skills

Strong organizational skills

Attention to detail

Written and verbal communication

Multitasking abilities

MS Office proficiency

Cross-functional teamwork

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 provide operational support across our clinical development programs in a fast-paced biotech environment.

You will collaborate with Clinical Trial Managers, CROs, and study sites to ensure trials adhere to ICH/GCP, regulation, and SOPs while maintaining inspection-ready TMFs. The role emphasizes meticulous documentation, study trackers, site onboarding, and cross-functional communication, with a path to grow within a dynamic