Clinical Trial Assistant

Location
San Carlos, California
Posted
Mar 26, 2021
Required Education
Bachelors Degree
Position Type
Full time

Alkahest is a clinical stage biopharmaceutical company targeting neurodegenerative and age-related diseases with transformative therapies derived from a deep understanding of the plasma proteome in aging and disease.

We are seeking a highly motivated and driven Clinical Trial Assistant / Associate (CTA) who will be integral in supporting our clinical efforts. The primary focus of the entry level CTA position is to support clinical study teams in the successful execution of clinical trials. The CTA will perform various administrative tasks and support the study team by creating, distributing, maintaining, and organizing study materials, tools, and documents to ensure conduct of clinical trials in compliance with protocol requirements, SOPs, and ICH GCP Guidelines.  

Alkahest offers a competitive compensation and benefits package, annual bonus potential, opportunities for career growth and development, and a work environment that is collaborative, collegial and lots of fun.

Responsibilities: 

Provide support to the clinical department to assist with execution and maintenance of clinical studies, including:

  • Assist in the start-up, management, close-out and reporting of assigned clinical research projects
  • Assist in budget tracking and invoice review, data entry, and processing
  • Assist in collection of ICH essential documents ensuring TMF is complete and appropriately maintained
  • Assist in preparation of project status reports for management review
  • Review monitoring visit reports and track resolution of all action items
  • Maintain, update, and establish various databases and metrics to support Sponsor oversight responsibilities
  • Assist in the development and management of research protocols, investigator’s manuals, informed consents, study plans, case report forms and budgets related to each project
  • Ensure appropriate documentation of all identified site- and protocol-related issues
  • Other responsibilities as assigned

Requirements:

  • Bachelor's degree in science, nursing, or equivalent preferred
  • Working knowledge of FDA and/or EMA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials
  • Familiarity with pharmaceutical and medical terminology
  • Experience with management and oversight of TMF
  • Experience with EDC platforms
  • Risk-based monitoring (RBM) experience is a plus
  • Working with trials conducted globally is a plus
  • Excellent interpersonal, verbal, and written communication skills
  • Strong attention to detail and organizational skills
  • Strong knowledge of MS Office Suite and Outlook
  • Willingness to travel up to 10% overnight