Site Activation Specialist (SAS)

Highly Competitive
  1. Permanent
  2. Clinical Trial Assistant (CTA)
  3. Japan
Tokyo, Japan
Posting date: 04 Sep 2023

Proclinical are partnering with a CRO who are currently recruiting for an individual to join their team. This role is on a permanent basis. The opening position is for a Site Activation Specialist.


  • Accomplish, handle and/or assist with country and site-specific actions necessary to activate sites for a clinical trial when suitable and when needed.
  • You might support SAM colleagues by advising them to foster quality delivery throughout the division.
  • The ideal candidate might assist with regulatory actions under direction when required for critical delivery or for professional self-development if ideal.
  • Gather, receive and conduct first evaluation of necessary study-specific site regulatory/necessary documents rendering to suitable SOPs, regulations, and pertinent study specific plans.
  • Execute corrective action when required, prior to necessary document evaluation sign off and follow up on non-Hold items post sign off.
  • Offer local follow up and update status of local EC proposals to the pertinent teams allocate to the project.
  • Familiarise yourself with and comply to SOPs, ICH GCP and any other suitable guidelines.
  • Any other assigned duties.

Key Skills and Requirements:

  • Educated to a degree level with a major in a medical, biological, physical, health, pharmacy or similar scientific field.
  • At least 1 year of experience working within clinical research, ideally within site activation or regulatory-linked function.
  • Familiarity working within a pharmaceutical/CRO industry.
  • Expertise in ICH GCP, EU clinical trials directive and any other pertinent clinical research.
  • Fluency in the Japanese language with knowledge in English.
  • An organised individual with the ability to manage own time efficiently.
  • Capable of planning, strategising, managing, monitoring, scheduling, and critiquing skills.
  • A motivated individual keen to learn present regulatory procedures and knowledge.
  • Able to share knowledge and train others within and beyond own division.
  • Communication skills both verbally and in writing.
  • Adaptable to constantly shifting settings.
  • Capable of prioritising workload with a high attention to detail.
  • Able to handle various tasks simultaneously within a fast-paced and changing setting.
  • Computer literacy.
  • Skilled with contemporary digital systems would be beneficial.
  • Works well in a team.
  • Comprehension of country level cultural norms and local healthcare systems.
  • Capable of initiating and developing relations with local investigators and key site personnel.
  • Comprehension of clinical research principles and procedure.

If you are having difficulty in applying or if you have any questions, please contact Erik Tarpley at

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.