Sr. Clinical Trial Associate

The person in this role will assist and support the Clinical Operations Lead/Study Manager and the study conduct team in the execution of clinical study(ies) conduct to support project team goals and objectives. The scope of this position may support multiple studies. 

Role Responsibilities: 

• Support the clinical operations team in the successful execution of clinical trials from protocol concept to clinical study report 
• Prepare and maintain study related files 
• Organize study and departmental meetings, take minutes, and ensure all study documentation is appropriately archived 
• Coordinate clinical trial equipment and supplies 
• Coordinate cross-functional project related activities (e.g., Clinical Data Review Meetings) 
• Ensure clinical team compliance with all required study specific training 
• Perform TMF reviews to ensure completeness 
• Ensure inspection readiness and provide support to sites to prepare for clinical audits/inspections 
• Assist with budget management 
• Support the day-to-day operations of clinical study execution in compliance with applicable SOPs, ICH/GCP guidelines and other regulatory requirements. 
• Activities may include tracking of appropriate subject and site activity/metrics, performing quality check activities across components of the clinical study, etc. 
• Proactively identify and escalate issues that arise related to support functional deliverables. 
• Assist in study set-up including but not limited to protocol/synopsis preparation, informed consent form preparation and review, systems (i.e., CTMS, IRT, etc.), and regulatory submissions, study operational manuals, training manuals, investigator document review, various study plans (i.e., visit logs, drug inventory, monitoring plans, etc.), and other study-related requests. 
• Collaborate with CRO on the timely collection and archiving of TMF documents for assigned studies/programs. Coordinate with regulatory on the ongoing submission of essential documents to regulatory authorities. 
• Assist in the management of study completion activities with the CRO and the sites including TMF reconciliation, drug reconciliation, ensure that all documents are available for the CSR. 
• Effectively communicate with study team members and work closely with Clinical Operations Lead/Study Manager. 
• May participate in process improvement and quality-related initiatives associated with study execution and deliverables. 
• Strong Organizational Skills 
• Must have excellent interpersonal, written, verbal communication, computer, and administrative skills 
• Computer ability 
• Minimal travel required (0 to 5%) 

Preferred Qualifications: 

• General knowledge of drug development and ICH/GCP 
• Pharmaceutical/Biotechnology Industry Experience 

Education and Experience Requirement: 

• Bachelor’s degree with at least 3 years of hands-on clinical trials experience. 
• Working knowledge of ICH/GCP regulations 
• Ability to work independently with minimal direction/oversight and within a team structure. 
• Ability to think critically in fast-paced environment with a keen sense of urgency and a demonstrated ability to problem solve. 

Job Type: Full-time 

Benefits: 

• 401K 
• Medical insurance 
• Dental insurance 
• Vision insurance 
• Supplemental disability insurance plans 
• Flexible schedule 
• Life insurance 
• Flexible vacation 
• Sick time 
• Incentive stock option plan 
• Cell phone reimbursement 

Schedule: 

• Monday to Friday 

Work authorization: 

• United States (Required) 

Additional Compensation: 

• Annual targeted bonus % 

Work Location: 

• On site required – La Jolla / Torrey Pines 

Company’s website: 

• www.januxrx.com 

COVID-19 Vaccination required 

Janux requires all new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Janux will consider requests for Reasonable Accommodations. 

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