{"id":63923,"date":"2026-08-10T14:04:37","date_gmt":"2026-08-10T07:04:37","guid":{"rendered":"https:\/\/www.oucru.org\/?post_type=career&#038;p=63923"},"modified":"2026-08-10T15:31:50","modified_gmt":"2026-08-10T08:31:50","slug":"oucru-id-regulatory-research-associate-jakarta","status":"publish","type":"career","link":"https:\/\/www.oucru.org\/vi\/career\/oucru-id-regulatory-research-associate-jakarta\/","title":{"rendered":"OUCRU ID \u2013 Regulatory Research Associate \u2013 Jakarta"},"content":{"rendered":"\n<ul class=\"wp-block-list\">\n<li><strong>Group:<\/strong>&nbsp;Clinical Research Management and Governance, OUCRU Indonesia<\/li>\n\n\n\n<li><strong>Location:<\/strong>&nbsp;Jakarta (with frequent travel to sites expected)<\/li>\n\n\n\n<li><strong>Hours of Work:<\/strong>&nbsp;1.0 FTE<\/li>\n\n\n\n<li><strong>Tenure:<\/strong>&nbsp;Initially for&nbsp;01&nbsp;years&nbsp;with&nbsp;possibility&nbsp;of extension<\/li>\n\n\n\n<li><strong>Reporting to:&nbsp;<\/strong>Head of Clinical Research Management and Governance<\/li>\n\n\n\n<li><strong>Vacancy Reference:<\/strong>&nbsp;OUCRU ID \u2013 Regulatory Research Associate \u2013 Jakarta<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">Background<\/h3>\n\n\n\n<p id=\"p-rc_9c80046eb049ee0d-49\">The Oxford University Clinical Research Unit (OUCRU) is a large-scale clinical and public health research unit, with sites offices in Ho Chi Minh City and Hanoi in Vietnam, Jakarta in Indonesia and Kathmandu in Nepal. In Vietnam, we are hosted by the Hospital of Tropical Diseases (HTD) in Ho Chi Minh City, and the National Hospital for Tropical Diseases (NHTD) in Hanoi.\u00a0OUCRU Nepal closely collaborates with the National Academy of Medical Sciences in Kathmandu, and OUCRU Indonesia exists in partnership with the Universitas Indonesia. As a\u00a0Wellcome\u00a0Trust Africa Asia\u00a0Programme, we have received considerable support from the\u00a0Wellcome\u00a0Trust since our establishment in 1991.\u00a0\u00a0<\/p>\n\n\n\n<p>OUCRU\u2019s vision is to have&nbsp;local,&nbsp;regional&nbsp;and global impact on health by leading a locally driven research&nbsp;programme&nbsp;on infectious diseases in Southeast Asia. Priority is given to health issues important to the hospitals where we work, and to the countries&nbsp;as a whole where&nbsp;we&nbsp;operate: Vietnam,&nbsp;Indonesia&nbsp;and Nepal.&nbsp;&nbsp;All work is intended not only to&nbsp;benefit&nbsp;the patients seen daily at our host hospitals, but also to help improve patient care.&nbsp;<\/p>\n\n\n\n<p>Please see more information on OUCRU website:&nbsp;<a href=\"http:\/\/www.oucru.org\/\" target=\"_blank\" rel=\"noreferrer noopener\">www.oucru.org<\/a>&nbsp;<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Key Responsibilities<\/h3>\n\n\n\n<p><strong><strong>System and Communication Tools Management<\/strong>&nbsp;<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Sets up, populates and accurately&nbsp;maintains&nbsp;information in OUCRU&nbsp;ID tracking and communication tools (e.g. CTMS, NAS, SharePoint,&nbsp;etc.) and supports others in the usage of these systems&nbsp;&nbsp;<\/li>\n<\/ul>\n\n\n\n<p><strong><strong>Study Document Management<\/strong>&nbsp;<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Operational responsibility for the correct set-up and maintenance&nbsp;of the local eTMF and ISF, including document tracking&nbsp;in&nbsp;accordance with&nbsp;ICH- GCP and local requirements.&nbsp;<\/li>\n\n\n\n<li>Ensures essential documents under their responsibility are of&nbsp;quality and&nbsp;maintain&nbsp;Inspection Readiness&nbsp;<\/li>\n\n\n\n<li>Contributes to the production and maintenance of study&nbsp;documents, ensuring template and version compliance.&nbsp;<\/li>\n\n\n\n<li>Ensures that all study documents are ready for final archiving and&nbsp;completion of local part of the TMF and supports the CTC in the&nbsp;close out activities for the ISF.&nbsp;<\/li>\n<\/ul>\n\n\n\n<p><strong><strong>Regulatory and Study Authorization<\/strong>&nbsp;<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Contributes to clinical research applications\/submissions by&nbsp;handling clinical-regulatory documents according to the requested&nbsp;technical standards and supporting delivery to regulatory&nbsp;authorities.&nbsp;<\/li>\n\n\n\n<li>Interfaces with Local Study Team and Clinical Trial Coordinators&nbsp;during the document collection process to support effective&nbsp;delivery of a study and its documents.&nbsp;<\/li>\n\n\n\n<li>Assists&nbsp;in coordination and administration of clinical studies from&nbsp;the start-up to execution and close-out.&nbsp;<\/li>\n\n\n\n<li>Collects,&nbsp;assists&nbsp;in preparation,&nbsp;reviews&nbsp;and tracks documents for&nbsp;the application process.&nbsp;<\/li>\n\n\n\n<li>Assists&nbsp;in&nbsp;timely&nbsp;submission of proper application\/documents to&nbsp;OxTREC, EC\/IRB and, where&nbsp;appropriate to&nbsp;Regulatory Authorities&nbsp;for the duration of the study.&nbsp;<\/li>\n\n\n\n<li>Support Senior Research &amp; Grant Administrator to prepare,&nbsp;submit,&nbsp;track and document applicable permits required by the respective&nbsp;research (including local research permit, import permit etc.)&nbsp;<\/li>\n\n\n\n<li>Ensures compliance with local,&nbsp;national&nbsp;and regional legislation, as&nbsp;applicable.&nbsp;<\/li>\n<\/ul>\n\n\n\n<p><strong><strong>IMP management<\/strong>&nbsp;<\/strong><\/p>\n\n\n\n<p>Act as Clinical Trial Pharmacist back up:&nbsp;<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Supports the Clinical Trial pharmacist in reviewing protocols and&nbsp;study documents related to investigational drug management;&nbsp;<\/li>\n\n\n\n<li>Liaise with study team and\/or coordinator to&nbsp;establish&nbsp;site&nbsp;pharmacy\u2019s role, and to implement dispensing,&nbsp;compounding&nbsp;and&nbsp;billing procedures;&nbsp;<\/li>\n\n\n\n<li>Maintaining Pharmacy Binder;&nbsp;<\/li>\n\n\n\n<li>Ensures and coordinates distribution of an up-to-date&nbsp;investigational drug trials list and stock at OUCRU ID;&nbsp;<\/li>\n\n\n\n<li>Ensures that the investigational drug is handled, stored,&nbsp;identified&nbsp;and dispensed&nbsp;in accordance with&nbsp;the applicable requirements and&nbsp;quality standards;&nbsp;<\/li>\n\n\n\n<li>Ensures the accountability through good documentation practice in&nbsp;all activities related to investigational drug management; and&nbsp;<\/li>\n\n\n\n<li>Liaise with the hospital and\/or health facility pharmacy involved in&nbsp;storage and distribution of investigational drug<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">Requirements<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Bachelor Degree (Registered Pharmacist)<\/li>\n\n\n\n<li>Work experience: Minimum 2 years in Regulatory Affairs (pharmaceutical company, clinical research organisation) and\/or community or clinical pharmacy<\/li>\n\n\n\n<li>Experience in clinical trial regulatory and QA activities<\/li>\n\n\n\n<li>Knowledge in document management<\/li>\n\n\n\n<li>Excellent English scientific writing and communication skills<\/li>\n\n\n\n<li>Ability to work effectively in matrix environment<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">How to Apply<\/h3>\n\n\n\n<p>Please submit the following documents by email to&nbsp;<strong>recruitment.id@oucru.org<\/strong>:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Cover letter<\/li>\n\n\n\n<li>Curriculum vitae<\/li>\n\n\n\n<li>Names and contact details of a minimum of two professional referees<\/li>\n\n\n\n<li>Salary expectations<\/li>\n<\/ul>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><strong>Email Subject:<\/strong>&nbsp;Please quote the reference&nbsp;\u201c<strong>OUCRU ID \u2013 Regulatory Research Associate \u2013 Jakarta \u2013 Your name\u201d<\/strong>&nbsp;<\/p>\n<\/blockquote>\n\n\n\n<p><strong>Deadline for submission<\/strong>: 21 August 2026<\/p>\n\n\n\n<p><em>Only shortlisted candidates will be contacted.<\/em><\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Contact person<\/h3>\n\n\n\n<p>Iwan Tarmizi\/Eka Yuninda<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Background The Oxford University Clinical Research Unit (OUCRU) is a large-scale clinical and public health research unit, with sites offices in Ho Chi Minh City and Hanoi in Vietnam, Jakarta [&hellip;]<\/p>\n","protected":false},"author":55,"featured_media":0,"menu_order":0,"template":"","meta":{"_acf_changed":false,"_links_to":"","_links_to_target":""},"categories":[146],"tags":[],"class_list":["post-63923","career","type-career","status-publish","hentry","category-indonesia"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v25.3.1 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>OUCRU ID \u2013 Regulatory Research Associate \u2013 Jakarta - OUCRU<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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