Clinical Research Associate

4 days ago

Bangkok, Bangkok, Thailand Tigermed Full time
  1. Job Purpose

1.1 This position is responsible for project management and study site management from site selection to initiation until monitoring and close-out of assigned clinical study studies in accordance with Tigermed or sponsor Standard Operating Procedures (SOPs), International Conference on Harmonization Good Clinical Practice standard (ICH-GCP), Clinical Practice standard (GCP) and other applicable regulations.

1.2 The position is responsible for ensuring that all data generated by the assigned sites is of high quality, on time and within budget.

2.Responsibilities

(a) Site management


• Study site selection, initiation (SIV) and clinical monitoring.


• Perform pre-study visit to ensure eligible sites are selected according to sponsor site selection criteria, including but not limited to adequate resources and experience.


• Prepare and conduct SIV to ensure adequate study training for relevant site staff to proceed with study start and conduct in compliance with protocol and relevant regulations.


• Ensure Principal Investigator/study staff complies with safety reporting requirements, as defined in protocol, SOP, ICH-GCP and GCP.


• Track study recruitment to ensure recruitment target is achieved in all studies.


• Conduct monitoring visit according to SDV plan and SOP; address issues with sites and complete monitoring visit report in a timely manner coordinating.


• Ensure timely coordination of study materials (drug, non-drug, equipments, CRFs) to the site for start-up and throughout the study.


• Assemble site specific EC submission dossier, and ensure submission to EC.

Training


• Provide ongoing training to site staff with regards to ICH-GCP, GCP, study protocol and requirements.


• Conduct site initiation to ensure that the site has a thorough understanding of the study protocol and requirements.

Documentation


• Ensure timely collection of essential documents in compliance with protocol and regulations at study start-up, during and at study close-down. Maintain and update these documents in investigator files, trial master files.


• Prepare/complete study records' archiving according to protocol and sponsor requirements.

(b) Drug Safety


• Ensure safety information is disseminated to all sites according SOP and applicable regulations.


• Ensure SAE is reported within the timeline in compliance with SOPs and applicable regulations.

(c) Finance and Administration


• Finalize budget and obtain signed contract from site, prior to site initiation visit.


• Ensure Study Payment Schedule is executed and retain relevant documents/receipts.

(d) Study Tools and system


• Update and maintain Study tools/systems in a timely manner.

  1. Qualifications

3.1 Bachelor degree or above in Medical, Pharmacology or Biology related major. The excellent candidates will not be restricted to the current requirements;

3.2 At least 2 year of CRA experience including experience in SSU part such as SSV, SSU (preparation submission package) and site monitor.

3.3 Good understanding and knowledge of Good Clinical Practice and clinical trial operation processes/procedures;

3.4 Good skills on Microsoft Word, Excel, PPT and Outlook, etc.

  • Senior Clinical Research Associate

    2 weeks ago

    Bangkok, Bangkok, Thailand ICON plc Full time ฿600,000 - ฿1,200,000 per year

    Senior Clinical Research AssociateICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical developmentWe are currently seeking a Senior Clinical Research Associate (CRA)...

  • Senior Clinical Research Associate

    2 weeks ago

    Bangkok, Bangkok, Thailand ICON plc Full time ฿1,800,000 - ฿3,600,000 per year

    Senior Clinical Research AssociateICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical developmentWe are currently seeking a Senior Clinical Research Associate (CRA)...

  • Research Associate, Research

    2 weeks ago

    Bangkok, Bangkok, Thailand CLSA Full time ฿15,000 - ฿4,800,000 per year

    Position DescriptionThe Research Associate is responsible for providing support to the research function in the office. The incumbent is primarily responsible for coordinating research activities (e.g., compiling research for daily packs and client visits) and working with Senior and Investment Analysts on research projects and client Requests. The incumbent...

  • Associate/ Clinical Project Manager

    2 weeks ago

    Bangkok, Bangkok, Thailand IQVIA Full time ฿1,200,000 - ฿2,400,000 per year

    Responsibilities: Has the overall responsibility for the study commitments within the country and for timely delivery of data to required quality.Leads Local Study Team consisting of CRA(s), CSA(s), for assigned study/studiesLeads and optimises the performance of the Local Study Team(s) at country level ensuring compliance with sponsor's Procedural...

  • Associate/ Clinical Project Manager

    2 weeks ago

    Bangkok, Bangkok, Thailand IQVIA Inc. Full time ฿250,000 - ฿400,000 per year

    Bangkok, ThailandFull timeR1515494HybridJob available in additional locationsThailandApply NowSave this jobEmailXLinkedInFacebookResponsibilities:Has the overall responsibility for the study commitments within the country and for timely delivery of data to required quality.Leads Local Study Team consisting of CRA(s), CSA(s), for assigned study/studiesLeads...

  • Clinical Psychologist

    2 weeks ago

    Bangkok, Bangkok, Thailand Institute of HIV Research and Innovation Foundation Full time ฿25,000 - ฿75,000 per year

    Clinical Psychologist (นักจิตวิทยาคลินิก) มีหน้าที่ให้การประเมิน บำบัด และสนับสนุนทางจิตใจแก่บุคคลหลากหลายกลุ่ม

  • Associate CRA

    6 days ago

    Bangkok, Bangkok, Thailand MSD Full time

    Job DescriptionWith support of Sr.CRA/CRA and/or CRA-Manager, acts as primary site contact and site manager throughout all phases of a clinical research study, taking responsibility of allocated sites.Responsibilities:Develops strong site relationships and ensures continuity of site relationships through allphases of the trial.- Performs clinical study site...

  • Associate CRA

    1 week ago

    Bangkok, Bangkok, Thailand MSD Full time

    Job DescriptionWith support of Sr.CRA/CRA and/or CRA-Manager, acts as primary site contact and site manager throughout all phases of a clinical research study, taking responsibility of allocated sites.Responsibilities:Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.Performs clinical study site...

  • Associate CRA

    1 week ago

    Bangkok, Bangkok, Thailand MSD Full time

    Job DescriptionWith support of Sr.CRA/CRA and/or CRA-Manager, acts as primary site contact and site manager throughout all phases of a clinical research study, taking responsibility of allocated sites.Responsibilities:Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.Performs clinical study site...

  • Clinical Implementation Manager

    2 weeks ago

    Bangkok, Bangkok, Thailand bioMérieux Full time $520,000 - $1,560,000 per year

    Primary Purpose And Overall Objective Of The JobAct as a clinical resource to demonstrate and promote the clinical value of our products and solutions to physicians & other healthcare providers by supporting their implementation within the hospital or healthcare environment in order to improve patient outcomes, provide real-world evidence, educate, and...