Clinical Trial Assistant / Associate
Alkahest, Inc.
San Carlos, EEUU
hace 6 días

Description

Uniquely positioned to enhance quality of life in aging, at Alkahest, we are pioneering science that is rapidly being translated to the clinic.

Our approaches utilize in vivo, in vitro, proteomic, and molecular techniques to identify new therapeutics and apply them to patients.

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 provide assistance with 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, stock options, 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, maintenance, and close-out of assigned clinical research projects
  • 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
  • Assist in managing the eTMF to ensure regulatory documents are accurate, complete, and appropriately maintained
  • Assist in developing study progress trackers and preparing project status reports for management review
  • Maintain, update, and establish various databases and study metrics to support Sponsor oversight responsibilities
  • Ensure appropriate documentation of all identified site- and protocol-related issues
  • Assist in contract, invoice, and budget management and tracking including obtaining appropriate approvals and signatures
  • Other responsibilities as assigned
  • Requirements :

  • Basic knowledge of FDA and / or EMA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials
  • Familiarity with pharmaceutical and medical terminology
  • Familiarity with regulatory documents and eTMF management
  • Experience with EDC platforms
  • 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
  • Apply today. We look forward to meeting you!

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