Annexon Biosciences is a clinical-stage biopharmaceutical company developing a pipeline of novel therapies for patients with classical complement-mediated disorders of the body, brain and eye. The Company’s pipeline is based on its platform technology addressing well-researched classical complement-mediated autoimmune and neurodegenerative disease processes, both of which are triggered by aberrant activation of C1q, the initiating molecule of the classical complement pathway. The Company’s first product candidate, ANX005, is a full-length monoclonal antibody formulated for intravenous administration in autoimmune and neurodegenerative disorders. The Company’s second product candidate, ANX007, is a monoclonal antibody antigen-binding fragment (Fab) formulated for intravitreal administration for the treatment of neurodegenerative ophthalmic disorders. Based on learnings from its initial trials, Annexon is advancing its current programs while evaluating additional orphan and large market indications. Annexon is deploying a disciplined, biomarker-driven development strategy designed to establish that each of its product candidates is engaging the specific target at a well-tolerated therapeutic dose in the intended patient tissue.
The Clinical Trial Specialist (CTS) is primarily responsible for the coordination of activities associated with the setup and management of clinical studies under the direction of, or as delegated by a member of the Global Clinical Operations team. Responsibilities will range from clinical study coordination to data entry projects and general office work.
This position will report to the Sr. Director of Global Clinical Operations.
Responsibilities include, but are not limited to:
· Help provide accurate and up-to-date study status information to the organization.
· Implement accurate tracking systems, forms, and other relevant documents to support clinical studies
· Assist the clinical operations team with vendor management, including tracking all study invoices and payments
· Assist in the preparation of spreadsheets, presentations, etc. utilizing Microsoft Office Suite.
· Assist in the periodic review and QC of eTMFs to support inspection readiness and archiving of completed studies
· Maintain electronic files of clinical trial documents for ongoing projects
· Coordinate logistics for clinical operations team meetings, kick-off meetings, etc. Prepare draft minutes from the various meetings for review and finalization
· Assist in the tracking of clinical lab samples for multiple clinical trials, including tracking shipments of samples from lab vendors and helping maintain documentation of reconciliation practices and follow up any outstanding items
· Science or nursing degree, BA, BS, RN, or higher
· Two or more years of experience as a clinical trial assistant or clinical study coordinator
· Knowledge of ICH GCPs is a plus
· Proficient with MS Word, Excel, and PowerPoint
· Strong interpersonal, communication (written and verbal)
· Excellent organizational skills
· Ability to work as part of a multi-functional study team
· Based in the San Francisco Bay Area preferred