Clinical Trial Specialist (CTS)

Annexon Biosciences•Brisbane, CA

5d•Hybrid

About The Position

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 Clinical Operations.

Requirements

Science or nursing degree, BA, BS, RN, or higher or equivalent combination of education and experience in Biotech or Pharmaceutical industry sectors
0 -2 years of experience as a Clinical Trial Assistant or Clinical Study Coordinator
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

Nice To Haves

Knowledge of ICH GCPs is a plus

Responsibilities

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