FSP-Start Up Associate (Hong Kong)

Hong Kong SAR ChinaOn-site

Responsibilities

Perform a review of final submission documents as applicable.
Ensure appropriate systems are updated accurately and compliantly, ensuring others follow established processes.
Anticipate and prevent issues and service failures from developing in their study, escalating when appropriate, negotiating when required.
Mentor and coach other Site Readiness and Regulatory Operations team members.
Collect and track all the necessary documents required and perform a quality review, formatting and compilation of the final documents for effective and compliant site activation and maintenance without supervision and liaise with stakeholders as applicable in site activation related items.
Develop project specific plans for the Site Activation component of assigned studies.
Review and approve projections and timelines to study teams, ensuring that they accurately represent the country’s performance and suggests mitigation actions in agreement with line manager.
Review and approve Country and Site Specific patient informed consents for compliance to local
Oversee start up activities (possibly across a range of studies) to ensure issues are identified, managed and, if necessary, escalated to the appropriate individual.

Responsibilities: Responsible for maintaining awareness of regulatory legislation, guidance and practice, ICH/GCP and relevant Sponsor requirements.
Qualifications (Minimum Required): University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology) AND 1 year work
experience in clinical research, including a strong working knowledge of the ICH guidelines and RA, IRB/IEC regulations.

Job Overview: Primary contact with investigative site(s) during site start-up activities and maintenance with responsibility for collection of the required investigator and essential documents for a study, to ensure EC/IRB/Third body/Regulatory Authority and any other local applications are made within the timelines agreed with project management and Site Readiness team and that documentation meets the specifications required by applicable regulations and sponsor.