Careers

Clinical Trial Assistant / Sr. Clinical Trial Assistant

Description

Neoleukin Therapeutics is looking for a Clinical Trial Assistant to join our Clinical Operations team.  This position will provide operational support for upcoming clinical trials in cancer and autoimmunity, including the planning, coordination and execution of multiple early phase immuno-oncology studies. If you are a resourceful, independent, collaborative individual looking to join a fast-growing organization, please apply!


Responsibilities

  • Clinical Operations support of Neoleukin clinical trial(s), including support of trial site communications, documentation and monitoring
  • Collaborate with Protocol Lead (PL) to support achievement of study activities and milestones
  • Collect, maintain, disseminate and track clinical documents from study sites
  • Establish and maintain clinical contact information for sites, teams and vendors
  • Assist with the generation and/or review of study and site level documents, including but not limited to plans, training materials, informed consent forms and study manuals
  • Maintain study and site trackers to support oversight of good clinical practice, risk assessment and trend reviews
  • Support team and sites during regulatory approval process, from regulatory packet preparation through IRB/EC approval
  • Generate agendas and minutes for study team meetings and track action items to fruition
  • Create and maintain clinical trial master file (CTMF) and serve as CTMF subject matter expert
  • Maintain clinical trial master system (CTMS) and serve as the CTMS subject matter expert
  • Support site level quality control reviews
  • Schedule study team activities and meetings


Qualifications

  • Bachelor’s degree required, preferably in a scientific or healthcare discipline
  • Minimum of two years of experience in clinical drug development in the pharmaceutical/biotech industry
  • Familiarity with essential documents, clinical operations and FDA GCP/ICH guidelines
  • Experience managing CTMF and site level files
  • Strong self-awareness, with proactive and positive approach to problem solving
  • Excellent oral, written, and medical communication skills required
  • Ability to thrive in a fast-paced and entrepreneurial environment
  • Ability to function as an independent contributor at a high level in a team setting
  • Flexibility to adapt to changing needs in real time
  • Excitement about the vision and mission of Neoleukin Therapeutics


Applications can be submitted to careers@neoleukin.com

Neoleukin Therapeutics is proud to be an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status, or age, and Neoleukin will not tolerate discrimination or harassment based on any of the above characteristics.