Serve as the primary point of contact for the Regulatory Start Up Manager (RSM) and/or Project Manager (PM) during start-up on allocated projects.
Provide expertise and guidance to RSM and/or PM on country and local regulations and practices, keeping abreast of developments and changes in regulations, guidelines and practices surrounding clinical trial approvals in relevant countries.
Work within the scope of the Regulatory Start Up plan or other applicable project plan, relevant SOPs, and ICH-GCP.
Provide country and site level information on submission deadlines and timeline metrics for local Regulatory Authority, Ethics Committees, Investigational Review Boards and other local bodies as appropriate.
Works within forecasted submission/approval timelines and ensures they are complied with, updating appropriate systems accurately and in a timely manner, including planned and actual dates of submissions/approvals.
May serve as a point of contact with investigative sites for Regulatory Authority, Ethics Committees/Review Boards and other local authority related activities.
Prepare and submits Central EC/IRB applications, local EC/Governance applications, Regulatory Authority applications, and other local regulatory authorities or site submissions as required.
May serve as a point of contact for Regulatory Authorities, Ethics Committees/Review Boards and other local authorities.
Prepare and submit ongoing amendments, notifications, safety reports and study related materials required by Regulatory Authorities, Ethics Committees/Review Boards and other local authorities as per local requirements.
Escalate any issue to the RSM and/or PM and provides rationale for submission/approval delays, and contingency plan to mitigate impact.
Perform country and site Informed Consent Form (ICF) customisation in line with local requirements.
Initiate translation of submission documents as applicable and review translated documents before submission.
Review and approve proposed packaging and labelling for clinical trial material.
Prepare and submits import/export license applications and management of licenses and custom clearance thereafter if required.
Register project onto an official clinical trial registry as agreed to with Client and update status as required.
Submit regulatory and ethics documents and relevant study correspondence to the trial master file and ensures accuracy and completeness of these documents.
Serve as an independent essential document reviewer and performs 2nd review of Activation Forms for IP release if required.
Where applicable, may act as a Country Lead for projects with no RSM.
[자격요건]
경력사항: 경력(2년 이상 ) 학력사항: 대학교(4년)졸업 직무기술: Regulatory Affairs