Clinical Trial Associate

Job Description

Job Description

The Clinical Trial Associate (CTA) will provide operational support for the planning, execution, and closeout of clinical studies across Janux Therapeutics' clinical development programs. The CTA will partner closely with Clinical Trial Managers, Clinical Operations leadership, CROs, study vendors, and investigative sites to ensure studies are conducted in compliance with protocol requirements, ICH/GCP guidelines, regulatory requirements, and internal SOPs. This individual will be responsible for coordinating study documentation, maintaining inspection-ready Trial Master Files (TMFs), tracking study metrics, supporting study start-up and closeout activities, and facilitating communication among cross-functional stakeholders. The ideal candidate is highly organized, detail-oriented, proactive, and eager to grow within a fast-paced biotech environment.

ESSENTIAL FUNCTIONS AND 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.

REQUIRED EDUCATION, EXPERIENCE, SKILLS, AND ABILITIES

• 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.
• Experience supporting autoimmune, immunology, or oncology clinical trials preferred.
• Working knowledge of ICH/GCP guidelines and applicable clinical research regulations.
• Experience maintaining clinical trial documentation and/or Trial Master Files (TMFs).
• Familiarity with clinical systems such as eTMF, CTMS, EDC, IRT, or related platforms.
• Strong organizational skills and exceptional attention to detail.
• Excellent written and verbal communication skills.
• Ability to manage multiple priorities in a fast-paced environment.
• Proficiency with Microsoft Office Suite, including Excel, Word, PowerPoint, and Outlook.
• Demonstrated ability to work collaboratively across cross-functional teams.
• Ability to work independently in a fast-paced environment while appropriately escalating issues.
• Minimal travel required (0-10%).

In addition to a competitive base salary ranging from $105,000 to $115,000, we offer stock options, restricted stock units, a stock purchase plan (ESPP) and a target bonus. Janux also provides a comprehensive benefits package for our employees and their families, which includes medical, dental, vision, and supplemental disability insurance. Relocation assistance may also be available.

Please note that the hourly rate range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies, and internal equity.

Job Type:  Full-time

Benefits:

· Annual bonus program

· Incentive stock option plan

· 401k plan with flat non-elective employer contribution

· Comprehensive medical insurance with 90-100% employer-paid premiums

· Dental and vision insurance

· HSA, FSA, and supplemental insurance plans (life, disability, accident, critical illness, hospital indemnity)

· Unlimited PTO

· Generous holiday schedule; includes summer and winter company shutdown

· Relocation assistance

Schedule:

· Monday to Friday

Work authorization:

· United States (Required)

Additional Compensation:

· Annual targeted bonus %

Work Location:

· Onsite in our San Diego office preferred; hybrid arrangements may be considered with approval and require a minimum of three days per week onsite.

EQUAL OPPORTUNITY EMPLOYER:

Janux Therapeutics, Inc. is an equal opportunity employer that is committed to providing a work environment free of harassment and discrimination based upon a protected category, as well as an environment free from retaliation for protected activity.

Notice to Recruiters and Third-Party Agencies

The Talent Acquisition team manages the recruitment and employment process for Janux. To protect the interests of all parties involved, Janux will only accept resumes from a recruiter once a fully-executed search agreement is in place. Agencies are hereby specifically directed not to contact Janux employees directly in an attempt to present candidates. Janux will consider any candidate for whom an Agency and/or Recruiter has submitted an unsolicited resume to have been referred, free of any charges or fees.

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.