Description
Company Summary Clinical Trial Specialist Job Description Our client is a clinical-stage biopharmaceutical company developing a new class of complement medicines for patients with classical complement-mediated autoimmune, neurodegenerative, and ophthalmic disorders of the body, brain, and eye. The companys pipeline is based on its platform technology addressing a broad spectrum of well-researched classical complement-mediated autoimmune and neurodegenerative diseases triggered by aberrant activation of C1q, the initiating molecule of the classical complement pathway. The Company is advancing a portfolio of innovative product candidates designed to block the activity of C1q and the entire classical complement pathway: intravenous administration, intravitreal administration, and subcutaneous administration. The Company is deploying a disciplined, biomarker-driven strategy designed to improve the probability of technical success of its portfolio. Company is HQed in the SF peninsula hear SFO airport and has approximately 63 employees. Desired Candidate Profile As the companys Clinical Trial Specialist (CTS) you will primarily be 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. Your 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. Position is located at corporate headquarters in the SF peninsula near the SFO airport. Specific 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. Key Qualifications Science or nursing degree, BA, BS, RN, or higher Experience as a clinical trial assistant or clinical study coordinator is a plus 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 The Clinical Trial Specialist will be required to be fully vaccinated against the Covid-19 virus. An applicant is considered fully vaccinated two weeks after their second dose in a 2-dose series, such as the Pfizer or Moderna vaccines, or two weeks after a single-dose vaccine, such as Johnson & Johnsons Janssen vaccine. You will be required to show proof of vaccination status upon hire. The Company provides reasonable accommodations in accordance with applicable state, federal and local laws. Powered by JazzHR OLiJEViR1z
