Senior Clinical Trial Associate

Foresite Labs

Foresite Labs

South San Francisco, CA, USA
Posted on Saturday, February 17, 2024

Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients.

As a Senior Clinical Trial Associate (Sr. CTA) at Alumis, you will play a crucial role in supporting the Clinical Operations team across the full spectrum of study activities. This includes site activation, patient recruitment, study monitoring, and managing relationships with sites and vendors during Phase 2 / 3 trials. You will collaborate closely with various departments within Alumis and work alongside study sites, Contract Research Organizations (CROs), and other vendors. Embracing our core values—We Elevate, We Challenge, We Nurture—you will contribute to our mission of advancing innovative treatments and improving patient outcomes.

This role will start as a contractor with the potential to be hired as a full-time employee.

Essential Responsibilities:

  • Conduct site feasibility and recruitment, including reviewing Site Information Questionnaires.
  • Review clinical documents (protocols, ICFs, and manuals) for clarity and accuracy, ensuring compliance with ICH/GCP guidelines.
  • Review study plans, including Clinical Monitoring, Communication, Project Management, and electronic Trial Master File (eTMF) Management.
  • Audit data fields within electronic data capture (EDC) systems, collate and download reports to support study management and data review.
  • Participate in user acceptance testing (UAT) of clinical systems, including EDC and interactive response technology (IRT), and may contribute to authoring system requirements.
  • Review and track essential regulatory documentation from clinical sites before study start-up and throughout study conduct.
  • Conduct site-specific Informed Consent Form (ICF) reviews.
  • Review Site Visit Reports for accuracy, quality, and consistency.
  • Assist with managing study vendors.
  • Support TMF quality control and reconciliation of findings.

Professional Experience / Qualifications:

Typically requires a minimum of 3 years of experience and/or a combination of experience and education/training (e.g., Clinical Trials Design and Management Certificate).

Preferred Education:

Bachelor’s degree, preferably in biological sciences, health care management, or life sciences research; BSN/RN or experience with management of clinical trials.

Preferred Experience:

  • Strong understanding of the Trial Master File (TMF) structure, DIA model.
  • Good written and verbal communication skills with a proven ability to multitask.
  • Efficient time management and organizational skills.
  • Attention to detail and accuracy in work.

Preferred Computer Skills:

Proficiency in Microsoft Office (Word, Excel, Outlook), Smartsheet, electronic TMF, and electronic clinical technologies.

Alumis Values

  • Elevate
  • Challenge
  • Nurture

This position is located in South San Francisco, CA, with expectation of being in the office 3 days a week, Tuesday through Thursday. At this time we are not considering remote applicants.

The salary range for this position is $ 105,000 USD to $120,000 USD annually. This salary range is an estimate, and the actual salary may very based on the Company’s compensation practices.

Alumis Inc. is an equal opportunity employer.