Ｗｏｒｌｄｗｉｄｅ Ｃｌｉｎｉｃａｌ Ｔｒｉａｌｓ Ｊａｐａｎ株式会社
SUMMARY:
:The Site Activation Specialist is responsible for supporting Site Activation Manager
(SAM) in activation and maintenance activities with emphasis on the quality and delivery of the Site
Regulatory Package (SRP). Responsibilities include Essential Document distribution, collection,
tracking, review and provision of country/site requirements to support achievement of site activation
goals and ongoing maintenance activities in compliance with Good Clinical Practices (GCPs) and
applicable local and international regulations and Standard Operating Procedures (SOPs).
Conducts and supports site level feasibility assessments by coordinating site identification at a
country and regional level. This includes supporting site qualification, site start-up activities pertaining
to Regulatory Authorities and Ethics Committee submissions under the direction of the Regulatory
Affairs team and Site Activation Manager; and liaison with sites to support contracts/budget
negotiations under the direction of the Site Contracts team.
RESPONSIBILITIES:
Tasks may include but are not limited to:
Track study-specific site regulatory documents by site and/or country and follow up with sites
or internal team members as needed and escalates to the Site Activation Manager
Support the development, adaptation, and review of country/site specific informed consent
forms
Maintain regular communication with sites to ensure timely completion of start-up and
maintenance activities
Interface with relevant functional leads to ensure appropriate prioritization of essential
document collection and review to facilitate synchronized start-up
Collect, receive, and perform first review of required study-specific site regulatory/essential
documents in accordance with applicable SOPs, guidelines, and relevant study specific plans.
Implement corrective action as needed, prior to essential document review sign off and follow
up on Non-Hold items post sign off (where applicable)
Where applicable, provide local follow up and updates of status of local EC submissions to the
relevant teams assigned to the project
Where required, complete, manage and/or support country and site-specific activities required
to activate sites for a clinical trial as appropriate
May perform pre-award feasibility studies
Support Site Identification activities including the negotiation and collection of Confidential
Disclosure Agreements and the collection and analysis of Site Feasibility Questionnaires
Support the collection of country and site level intelligence
Support the development of a preliminary potential site list
Support translations according to governing SOPs
May help advise SAM colleagues to foster quality delivery throughout the department
May support regulatory activities under guidance as needed for critical delivery or for
professional self-development if desired
Be familiar with and comply with SOPs, ICH GCP and applicable regulations
Maintain an understanding of FDA and/ or EU Directives and regulations, ICH Guidelines and
country/local regulatory requirements.
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