シミックホールディングス株式会社／CMIC HOLDINGS Co., Ltd. (HQ) Overseas の求人一覧
全 3 件中 3 件 を表示しています
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Clinical Research Associate I or II/Senior CRA ※Singapore Office
This is a full-time position required in Singapore. POSITION PURPOSE: 1. To support project(s) as ICH E6 GCP definition of "Monitor" 2. To ensure all designated clinical/site monitoring activities are conducted in highest quality standards Support in operations and/or business's continuality by undertaking tasks such as: 1. Mentoring and training of new employees as required 2. Support business development activities 3. Review, revise and/or develop clinical operations service related work guides or site specific documents etc. RESPONSIBILITIES: Responsible for performing all monitoring aspects of clinical trials and assist to set up, review and maintain project files to ensure compliance as stated in ICH E6 GCP to assure all trials are conducted in strict adherence to good clinical practices, regulatory obligations, investigator integrity and compliance with project specific requirements Responsible for preparing, organizing, managing feasibility, site selection and investigator identification, initiation, monitoring an close-out visits in accordance with sponsor's and/or company's standard operating procedures (SOPs) and study requirements with the highest standards Planning, develop, compile and/or review all study-related regulatory and administrative documents from investigational sites, monitoring visit reports, work progression reports and other study-required documents Develop, compile and/or submit dossiers include initial/amendment/interim report/safety reporting to regulatory and/or ethics committee for review and follow up until approval, as required Management in planning, coordinating, organizing and attending all study-related meetings and activities for sites as required Manage/support project(s) in the capacity of lead CRA role and/or other designated project roles to undertake all or partial responsibilities and tasks as required, whenever designated by the Company Support/Assist in Site and CRO audit or inspection as required Support business development activities (e.g. search new project related information) as required Support/assist in regulatory research/consultancy tasks in relation to clinical trial planning, conduction and product application/registration Proactively identify and facilitate resolution of complex study problems and issues. Actively work towards achieving good personal relationships with the project Team members REQUIREMENTS: Qualifications Minimum bachelor degree (major in nursing, pharmacy or other biomedical-related background) from a recognized institution, and/or equivalent combination of training and experience Certificate in basic GCP courses Certificate in monitoring or equivalent training Experience and Skills Minimum 1 year relevant experience in clinical research in healthcare, pharmaceutical and/or CRO industry or 1 year direct experience as monitor in clinical studies Preferably has experience in clinical study monitoring Good knowledge of ICH/GCP guidelines, SOPs and other applicable regulations Strong interpersonal, problem-solving, organization and time management skills Ability to produce meticulous and accurate work under pressure and stringent timelines Able to work independently and willingness to travel Strong computer/technology skills including MS Word, MS Excel and PowerPoint Good written and verbal communication skills Self-initiative to perform duties Meticulous and able to work in a fast-paced environment Good team-player Ability to multi-task and follow through with assigned tasks Good knowledge of ICH/GCP guidelines, SOPs and other applicable regulations LOCATION: Hybrid Work Arrangement. Office at Shenton Way APPLICATION: Interested parties please send your application via email to: Name: Pearlyn Tan Email: pearlyn-tan@cmicgroup.com 続きを見る
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Research Analyst【CMIC, Inc.】
Research Analyst – The Research Analyst will perform lab activities in accordance with applicable Methods, Plans, SOPs/SWPs, GLP regulatory guidelines and 21 CFR Part 11 as directed from Group Leader and Sr. Analysts. Conduct Bio-analysis validation and sample analysis independently. Conduct Pre-Study with minimal supervision. Utilize establish techniques to compile and analyze data. Document work and maintain study documentation and lab records. Provide direction and technical assistance to lesser-skilled team members. Assist with SOP/SWP preparation and other technical related documents including client communications. Perform other routine laboratory duties as deemed necessary. Maintain a safe environment. Requirements: Bachelor’s or foreign degree equivalent in Chemistry, Food Science, Engineering, Food Technology or related field and 1 year of experience in the job offered or experience working in a regulatory laboratory environment. Special skills: 1 year of experience in LC-MS/MS and/or UHPLC-UV; UHPLC-FD; understanding GLP requirements and SOP/SWPs; and utilizing analytical techniques to perform sample analysis. Worksite Location - 2860 Forbs Ave., Hoffman Estates, IL 60192 Any Applicant who is interested in this position may apply by regular mail to: D. Washick CMIC, Inc. 2860 Forbs Ave. Hoffman Estates, IL 60192 続きを見る
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Clinical Research Associate I or II ※Vietnam
This is a 1 year contract home-based in Ha Noi, Vietnam. The type of contract could be extended after CRA performance review. POSITION PURPOSE: 1. To support project(s) as ICH E6 GCP/applicable local GCP definition of “Monitor” 2. To ensure all designated clinical/ site monitoring activities are conducted in highest quality standards 3. To support project management, clinical monitoring and/or regulatory affairs operations in all aspects of the project(s) 4. To support study start up activities to ensure on-time start up and initiation of the study as possible 5. To assist project team in all project related administrative tasks including status and financial tracking 6. To support project in capacity of “Clinical Trail Assistant (CTA)” as required 7. To provide relevant support and assistance whenever required by the company and project team RESPONSIBILITIES: Responsible for preparing, organizing, managing and monitoring clinical trials in accordance with the highest standards Responsible for performing all monitoring aspects of clinical trials as stated in ICH E6 GCP/applicable local GCP to assure all trials are conducted in strict adherence to good clinical practices, regulatory obligations, investigator integrity and compliance with project specific requirements Perform site selection, initiation, monitoring and close-out visits in accordance with sponsor’s and/or company’s standard operating procedures (SOPs) and study requirements Develop, compile and/or review all study-related regulatory and administrative documents from investigational sites, monitoring visit reports, work progression reports and other study-required documents Develop, compile and/or submit dossiers to regulatory and/or ethics committee for review and follow up until approval, if required Support in safety reporting to regulatory and/or ethics committee as required Support in planning, coordinating, organizing and attending all study-related meetings and activities for site as required Support/assist in feasibility studies, site and investigator identification as required Manage/support project in the capacity of Clinical Research Associate, Clinical Trial Assistant and/or designated project roles to undertake all or partial responsibilities and tasks as required, whenever designated by the company Support/assist in Site and CRO audit or inspection as required Assist to set up, review and maintain project files to ensure compliance to ICH E6 GCP/applicable local GCP, applicable local regulatory and project requirements Support Company’s operations by assisting/coordinating and conducting orientation and applicable training for new employees as required Review, revise and/or develop Clinical Monitoring related SOPs, work guides etc. REQUIREMENTS: Qualifications Minimum bachelor degree (major in nursing, pharmacy or other biomedical-related background) from a recognized institution, and/or equivalent combination of training and experience Certificate in basic GCP courses Certificate in monitoring or equivalent training Experience and Skills Minimum 2 year relevant experience in clinical research in healthcare, pharmaceutical and/or CRO industry or 1 year direct experience as monitor in clinical studies Preferably has experience in clinical study monitoring Good knowledge of ICH/GCP guidelines, SOPs and other applicable regulations Strong interpersonal, problem-solving, organization and time management skills Ability to produce meticulous and accurate work under pressure and stringent timelines Able to work independently and willingness to travel Strong computer/technology skills including MS Word, MS Excel and PowerPoint Good written and verbal communication skills Self-initiative to perform duties Meticulous and able to work in a fast-paced environment Good team-player Ability to multi-task and follow through with assigned tasks Good knowledge of ICH/GCP guidelines, SOPs and other applicable regulations LOCATION: Home-based in Ha Noi, Vietnam APPLICATION: Interested parties please send your application via email to: Name: Ha Thi Tra My Email: tramy-hathi@cmicgroup.com 続きを見る
全 3 件中 3 件 を表示しています