Senior Clinical Trial Associate - Iambic Therapeutics, Inc.

JOB TITLE: Senior Clinical Trial Associate 

JOB SUMMARY

This role is based on site at the San Diego headquarters. The Senior/Clinical Trial Associate (Sr. CTA) will support clinical studies and the Clinical Operations Department by managing various administrative tasks, including generating agendas and minutes, maintaining study tracking, and conducting filing and quality reviews. This role will also involve participating in process improvement initiatives across departments. The Sr. CTA will report to the Director of Clinical Operations and will be instrumental in collaborating cross-functionally, working closely with study teams from vendors and CROs to achieve departmental and project goals.

The Sr. CTA must adhere to the company’s core values and comply with all applicable regulations, ICH-GCP guidelines, and SOPs. Strong candidates should have a solid understanding of trial and study site management, vendor management, and experience participating in the full cycle of studies from start-up to close-out.

KEY RESPONSIBILITIES

• Provide general administrative support to the Clinical Operations Department 
• Assist in the production of presentations as needed for project, departmental, and/or business development
• Assist the Study Lead(s) with Sponsor oversight of CRO, including study-specific documentation review and QC, and reviews of ICFs, study plans, study reference manuals, eCRFs, etc.
• Assist with creation and maintenance of study metrics trackers, tools and reports
• Assist in coordination and tracking of Investigator and third-party payments
• Ensures required study documents are submitted to the CRO-held eTMF
• Assists the Study Lead(s) with Sponsor oversight of CRO-held eTMFs, including periodic audit and findings resolution
• Assist the Study Lead(s) in executing clinical monitoring oversight
• Assists with customization of CDA, clinical site contracts & budgets, when applicable
• Assist the Study Lead(s) and clinical team with Investigator Meeting coordination, activities preparation and generate meeting minutes
• Coordinate document translation, if required
• May contact clinical sites for specific requests (e.g., enrollment updates, missing documentation, meeting arrangements, etc. when needed)
• Attends internal and external team meetings/teleconferences and generate meeting agenda and minutes when needed

QUALIFICATIONS

• Bachelor's Degree or equivalent international degree
• 2 or more years or experience in pharmaceutical industry, clinical research organization (CRO), or related role; CRO experience preferred
• Experience working on Phase 1 and 2 studies and global/international studies is advantageous
• Experience and knowledge of ICH GCP, eTMF management and DIA TMF Reference Model
• Excellence in task management and collaboration
• Proficient in English language (spoken and written)

ABOUT IAMBIC THERAPEUTICS

Iambic Therapeutics is disrupting the therapeutics landscape with its cutting-edge generative AI drug discovery platform. We have assembled a world-class team that unites pioneering AI experts and seasoned drug hunters with strong track records of success in delivering clinically validated breakthrough treatments.  The Iambic Therapeutics platform has been demonstrated to deliver high quality, differentiated drugs to clinic with unprecedented speed and across multiple target classes and mechanisms of action.  We are focused on the advancement on our internal pipeline of clinical assets to address urgent unmet patient need in oncology and other therapeutic areas.

MISSION & CORE VALUES

The culture and work at Iambic Therapeutics are profoundly strengthened by the diversity of our people and our differences in background, culture, national origin, religion, sexual orientation, and life experiences. We are committed to building an inclusive environment where a diverse group of talented humans work together to discover therapeutics and create technologies.

PAY AND BENEFITS

We offer industry leading competitive pay, company paid healthcare, flexible spending accounts, voluntary life Insurance, 401K matching, and unlimited vacation to our team. We are in a brand-new state-of-the art facility in beautiful San Diego with an onsite gym, dining, and easy access to great places to live and play.