- Responsible for site feasibility and recruitment, including review of Site Information Questionnaires.
- Review assigned clinical documents (i.e. protocols, ICFs, and manuals) for clarity and accuracy and following ICH/GCP guidelines.
- Review study plans, including; Clinical Monitoring, Communication, Project Management, and electronic Trial Master File (eTMF) Management.
- Review of data fields within the electronic data capture (EDC) systems, including performing collating and downloading reports to support study management and data review.
- Participates in assigned activities related to user acceptance testing (UAT) of clinical systems, including EDC and interactive response technology (IRT) and may contribute to the authoring of systems requirements.
- Reviews and tracks required essential regulatory documentation from clinical sites prior to study start-up as well as updates during study conduct.
- Conducts site specific Informed Consent Form (ICF) review.
- Reviews Site Visit Reports for accuracy, quality and consistency.
- Assist with activities related to management of study vendors.
- Assist in performance of TMF QC and reconciliation of findings.
- Assists in Investigator Meeting planning.
- Responsible for clinical team meeting scheduling, agendas and minutes.
- Maintains trackers and updates routine study dashboards.
- Represents department in a professional manner; build and establish good relationships with investigators and all other study personnel.
- Builds stable relationships internally.
Education and/or experience - Bachelor's degree, preferably in areas such as biological sciences, health care management or life sciences research; BSN/RN or experience with management of clinical trials.
- Typically requires a minimum of 2 years of experience and/or combination of experience and education/training (i.e. Clinical Trials Design and Management Certificate).
- Strong understanding of the Trial Master File structure (TMF)
Special skills/knowledge - Highly proficient using the Microsoft Office Suite (i.e., Word, Excel, PowerPoint, Adobe)
- Knowledge in additional applications
- Good written and verbal communication skills and proven ability to multitask. Efficient time management and organizational skills.
- Attention to detail and accuracy in work.
Alumis Values - Elevate
- Challenge
- Nurture
This position is located in South San Francisco, CA. Team members are required in office 3 days per week. At this time we are not considering remote applicants.
Alumis Inc. is an equal opportunity employer. -
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Senior Clinical Trial Associate - South San Francisco, United States - Alumis Inc.
Description
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 Sr. CTA, you will work closely with the Clinical Operations team to support the full scope of study activities, including site activation, patient recruitment, study monitoring, and site and vendor management on Phase 3 trials. You will work cross-functionally within the Alumis team as well as with study sites, CROs, and other vendors.
This role will start as a contractor with the potential to be hired as a full-time employee.
Essential Duties
