諾佛葛生技顧問股份有限公司

The Researcher is responsible for the conduct of analysis related works according to GCP, GLP, CAP, Standard Operating Procedures (SOP), applicable Study Specific Procedures (SSP), and local regulatory requirements. Manage the operation of MT and aid physicians in the diagnosis, treatment, and prevention of diseases by testing patient specimens, correlating data, and reporting results in a timely manner to effect quality patient care. Responsibilities: Perform analysis work according to SOPs and guidance. Prepare, review, and approve various documents, including SOPs, protocols, reports, and analytical methods. Manage lab logistics, including purchasing, inventory control, and payment processing. Maintain instruments and ensure cleanliness and maintenance of the workspace. Take on the role of system owner for computerized systems, performing tasks such as validation tests, periodic reviews, and reporting. Attend training courses related to CAP/GCP/GLP/regulatory requirements. Study Based Responsibility (if needed) Analytical Study Director in Study Work as the Study Director, responsible for the overall conduct and final report of the study. Approve the study plan and any amendments by signature, and ensure Quality Assurance personnel receive timely copies. Make study plans, amendments, and SOPs available to study personnel. Ensure procedures in the study plan are followed and document deviations and take corrective action if necessary. Document and record all generated raw data. Validate computerized systems used in the study, sign and date the final report to indicate acceptance of responsibility for data validity, and ensure study materials are archived after completion. Study Personnel in Study Ensure personnel are knowledgeable in relevant Principles of Good Laboratory Practice. Provide study personnel with access to study plans and SOPs applicable to their involvement, with a responsibility to follow instructions and document any deviations. Emphasize the responsibility of all study personnel to promptly and accurately record raw data, comply with Good Laboratory Practice principles, and exercise health precautions to safeguard the integrity of the study.

Please do submit English resume to our company website. https://fa-euzi-saasfaprod1.fa.ocs.oraclecloud.com:443/hcmUI/CandidateExperience/en/job/1488?utm_medium=jobboard General Responsibilities: Manage staff in accordance with organization's policies and applicable regulations, including without limitation: planning, assigning, and directing work; managing performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems; acting as a coach and mentor for subordinates as they develop in their role. Participate in the selection and onboarding process for new staff by conducting candidate review and participating in the interviewing process. Conduct onboarding training for new staff in conjunction with Human Resources and Learning and Development training programs. Ensure that staff have the proper materials, systems access and training to complete job responsibilities. Provide oversight for the execution of the training plan, SOP review and mentored training experiences, as applicable. Maintain lab daily operation. Ensure the quality and timely of lab deliverable. Perform the tasks assigned by line manager. Refer to additional GLP/GCP Regulation Required Responsibilities while involved in GLP organization. As the member of test facility/site management. Delegated /assigned as the system owner for computerized system, do the corresponding work for system, such as validation test, periodic review, report, etc. GLP/GCP Regulations Required Responsibilities (if needed): Lab Manager Maintain an internal responsibility chart which identifies the individual(s) within a test facility who fulfil the responsibilities of management as defined by the Principles of Good Laboratory Practice. Ensure that a sufficient number of qualified personnel, appropriate facilities, equipment, and materials are available for the timely and proper conduct of the study. Ensure the maintenance of a record of the qualifications, training, experience and job description for each professional and technical individual. Ensure that personnel clearly understand the functions they are to perform and, where necessary, provide training for these functions. Ensure that for each study an individual with the appropriate qualifications, training, and experience is designated by the management as the Study Director before the study is initiated. Replacement of a Study Director should be done according to established procedures, and should be documented. Ensure, in the event of a multi-site study, that, if needed, a Principal Investigator is designated, who is appropriately trained, qualified and experienced to supervise the delegated phase(s) of the study. Replacement of a Principal Investigator should be done according to established procedures, and should be documented. Ensure documented approval of the study plan by the Study Director. Ensure that the Study Director has made the approved study plan available to the Quality Assurance personnel. Ensure the maintenance of a master schedule. Ensure that test facility supplies meet requirements appropriate to their use in a study. Ensure for a multi-site study that clear lines of communication exist between the Study Director, Principal Investigator(s), the Quality Assurance Programme(s) and study personnel. Ensure that test and reference items are appropriately characterized. Ensure that appropriate and technically valid Standard Operating Procedures are established and followed, and approve all original and revised Standard Operating Procedures. If necessary, function as Study Director for specific study, in this case, he/she must not have the responsibility of test facility/site management role in the study.

Please do submit English resume via our company website. https://fa-euzi-saasfaprod1.fa.ocs.oraclecloud.com:443/hcmUI/CandidateExperience/en/job/2281?utm_medium=jobboard Reporting to: Lab PM Head Position description: Responsible for the overall management of laboratory projects to ensure the adherence of the project to applicable quality standards ( GLP, CAP, GCP), approved timeline and budget in the service agreements. Lead the project team, manage internal/external communications, and identify suitable resources to facilitate efficiency improvement for project execution. Responsibilities: Responsible for the overall project planning and execution of the project per agreed timeline, budget, scope, and quality regarding the assigned projects. Ensure accurate and timely communication with customers regarding delivery of work product and project progress. Ensure that project members have the proper materials, systems access and training to complete project job responsibilities. Responsible for project tasks, including but not limited to lab documents development, bio sample import/ export permits application, query management, project status tracking, management and reporting. Identify quality issues within the study to implement appropriate corrective action plans. Escalate findings and action plans to appropriate parties. Participate and contribute to the BD project bidding and marketing activities, and to facilitate the success of business explore and contract award. Take on additional responsibilities that may be assigned by the line manager. Qualifications: Minimum of a Bachelor's degree or equivalent in Science or medical related filed. Three (+) years relevant work experience in the GLP/ clinical laboratory operations or project management is preferred. Skills and Competencies: Familiar with laboratory related activity processes throughout a clinical trial with good knowledge in GLP, CAP and local regulations. Excellent customer management and problem resolving skills. To be proactive, flexible, organized, and aim to mitigate risk, understanding plans and outcomes fluctuate, and be highly communicative during the entire process. Strong communication and interpersonal skills, fluent communication of speaking and writing in English is preferred. Demonstrated ability to deliver results to the appropriate quality and timeline metrics. Strong software and computer skills, including MS Office applications.

Reporting to: Lab Director, or Lab Manager Position description: The Researcher is responsible for the conduct of analysis related works according to GCP, GLP, CAP, Standard Operating Procedures (SOP), applicable Study Specific Procedures (SSP), and local regulatory requirements. Manage the operation of MT and aid physicians in the diagnosis, treatment, and prevention of diseases by testing patient specimens, correlating data, and reporting results in a timely manner to effect quality patient care. Responsibilities: • Conduct analysis work following related SOPs and guidance. • Draft/check/review/approve documents, such as SOP, protocol, analytical result, report and method. • Involve in lab logistics (general affair) management, such as purchasing, inventory controlling, payment applying. • Responsible for instrument maintenances, workspace cleaning/maintenance. • Delegated /assigned as the system owner for computerized system, do the corresponding work for system, such as validation test, periodic review, report, etc. • Participate in CAP/GCP/GLP/ regulatory related training courses. • Provide temporary supporting assigned by line manager. • Involve in sample collection kit/label preparation. • Involve in analytical study project management. • Refer to additional Study Based Responsibilities while being assigned in GLP project. Qualifications: Education and Experience: • A 4-year BS (Bachelor of Science) degree in Biochemistry, Biotechnology and Laboratory Science, Chemistry, or a related field. Or Junior colleague with over 3-year lab work experience and well qualified. Advanced degree is a plus for Associate Researcher/ Senior Researcher. • License of Medical Technician is required for Associate Researcher/ Senior Researcher in Central Lab. Skills and Competencies: • Familiar with all lab operation activities. • Excellent working knowledge of CAP/GCP, applicable law (local and country) and regulatory requirements. • Good communication skills. • Good verbal and written English or other second language skills. • Good problem-solving skills. • Effective time management and prioritization skills.

Job Summary： As a member of Central lab team, you will be supporting the start-up of a cell-based assay and flow cytometry analysis. You will help define the requirements for validation and will establish processes under line manager's supervision that will enable the Central lab to operate successfully with regard to the analysis and characterization of cell-based therapies or vaccines; specifically as a flow cytometry scientist. This role provides the opportunity to closely partner with the vaccine development and clinical trials as you define and execute the start-up activities associated with establishing flow cytometry / cell-based assay capabilities and expertise at Central lab. Responsibilities include flow cytometry / cell-based assay method development, validation, qualification, transfer and troubleshooting. In addition, the candidate will be expected to write the validation / analytical protocol and report. Additional responsibilities include validation of computer systems, and management/administration of equipment (e.g. instrument, etc.). General Responsibilities: 1.Collaborate with external groups to identify technology and business processes that will establish flow cytometry / cell-based assay expertise at Central lab. 2.Conduct analysis work following related SOPs and guidance. 3.Review data and evaluate against established acceptance criteria 4.Define requirements for laboratory equipment and support purchasing. 5.Evaluate data to identify trends and/or establish limits 6.Participant in discrepancy investigations and corrective actions 7.Receive and provide training 8.Lead assay development, transfer and validation activities 9.Write, review or approve equipment qualification/maintenance life cycle documents 10.Draft, check, review or approve documents, such as SOP, protocol, analytical result, report and method. 11.Write protocols and reports under limited supervision 12.Assure and apply GCP/CAP throughout operations 13.Participate in CAP/GCP/GLP/ regulatory related training courses. 14.Support internal, external, and regulatory inspections 15.Work to meet schedules, timelines, deadlines 16.Participate in and/or lead projects and process improvements 17.Delegated /assigned as the system owner for computerized system, do the corresponding work for system, such as validation test, periodic review, report, etc. 18.Provide input or set personal performance goals and departmental objectives Establish work priorities to meet targets and timelines; manage competing priorities Other tasks assigned by line manager. Clinical Lab Service Scientist 1.Participate in and/or lead projects and process improvements Delegated /assigned as the system owner for computerized system, do the corresponding work for system, such as validation test, periodic review, report, etc. 2.Provide input or set personal performance goals and departmental objectives Establish work priorities to meet targets and timelines; 3.Manage competing priorities Other tasks assigned by line manager.

加入我們的專業團隊，開啟您的亞太地區生物科技之旅！ 職缺: 檢體管理員 簡介: 我們是一家位於亞太地區的領先中心實驗室，專注於全球範圍內的臨床試驗相關檢測分析。我們的實驗室擁有GLP和CAP的認證，並致力於提供優質的服務，以支持藥物的科學研究與創新，以造福病友。其中需要檢體管理員這個重要的角色，協同其它檢體管理員們，在臨床試驗中進行檢體管理與處理的所有相關活動，以協助檢測分析的順利進行，同時符合法規等認證需求。不是醫療背景的你，你想穿著白袍在實驗室裡穿梭嗎? 你想對醫療有一份貢獻嗎? 你想要有獨立的辦公座位嗎? 你想要下午有免費的點心吃嗎? 你想要主管時不時請喝飲料嗎? 符合資格的朋友別猶豫了，快來加入我們。 職責範圍: 1. 主要工作: 負責檢體的接收、清點、標籤與核對，並確保檢體資訊的準確輸入至系統中，以及檢體的有效分發。 2. 次要工作: 協助組裝與檢查採檢套組，確保品質管控。 3. 文件管理: 負責案件檢體管理相關文件的掃描與歸檔。 4. 環境維護: 保持檢體管理區域的整潔與有序。 5. 團隊協作: 完成主管分配的其他相關任務。 個人特質要求: 1. 細心與耐心 2. 強烈的責任感 3. 良好的英語能力（多益550分以上、雅思4.5以上或同等水平） 4. 團隊合作精神與良好的邏輯思維 主管寄語：在這裡，我們重視的不僅僅是技能和知識，更看重每位團隊成員的人格與態度。即使您沒有相關經驗，只要有適合的人格特質，我們都願意提供學習與成長的機會。 加入我們，與我們一起推動生物科技的未來！

如果你是一位擁有醫檢師執照的專業人才，如果你對臨床試驗的檢驗分析有高度熱情，如果你渴望挑戰自我，我們需要你！ 我們正在尋找一位積極、具有創造力並對於檢驗分析充滿熱情的醫事檢驗師加入我們的團隊。作為我們的醫事檢驗師，你將可以在醫事檢驗所執業登記，並參與到檢驗前、中、後的活動。除了提供良好的工作環境並有免費的零食餵食以外，還有完善的教育訓練制度，我們同時擁有一個已有20多年美國病理學會(CAP)認證歷史的醫學實驗室，並致力於不斷提升自我，為臨床試驗中的受試者提供最好的檢驗服務。 如果你擁有生化、免液、血液與尿液、凝固學至少2項（如有分生plus），至少一年醫檢師的工作經驗，並在流式細胞儀分析、分子生物、病理檢驗染色、手工血清學有檢測或是方法開發經驗，那麼這是一個絕佳的機會，請盡快加入我們的團隊。同時，如果你擁有ISO-15189受訓證書或是有至少參加過一次CAP inspection的經驗，更是加分。 此外，我們歡迎積極、樂觀、勇於接受挑戰的個性的人加入我們的團隊。如果你渴望或是尋求機會可以跨足生技產業的行業展現自我，希望通過不斷學習和提高提升自我，那麼這將是一個絕佳的工作機會。如果你想脫離單調的醫院工作環境，請加入我們的團隊，開始一段全新的職業生涯。放下手中的鍵盤在靠北醫檢師社團的抱怨，期待你的加入！ If you are a licensed medical technologist with a passion for clinical trial testing and a desire to challenge yourself, we need you! We are looking for a proactive, creative and passionate medical technologist to join our team. As our medical technologist, you will be able to register for practice in the medical laboratory and participate in pre-analytical, analytical, and post-analytical activities. In addition to providing a good working environment and free snacks, we have a well-established educational training system and a clinical laboratory that has been certified by the College of American Pathologists (CAP) for more than 20 years. We are committed to continuous improvement and providing the best testing services for clinical trial subjects. If you have more than two years of medical technologist experience and have method development or analysis experience in flow cytometry analysis, molecular biology, pathology staining, and manual serology testing, this is an excellent opportunity to join our team. Furthermore, if you have an ISO-15189 training certificate or have participated in at least one CAP inspection, that's a plus. In addition, we welcome individuals with positive, optimistic, and challenge-accepting personalities to join our team. If you are eager or seeking opportunities to step into the biotech industry and show your talents through continuous learning and improvement, then this will be an excellent job opportunity. If you want to break away from the monotony of hospital work environments, join our team and start a new career.

工作內容： 1.行政與日常支援：耗材與試劑的-詢價&議價&訂貨&驗收與庫存管理及盤點，列印表單 (每天, 不定時) ，儀器保養、校正排程的追蹤與協調，記錄本的印製以及發放 (每周一次)，掃描文件(每周一次)，櫃檯收發文件及接聽電話 2.次要工作：委外文件歸檔處理 3.團隊協作: 完成主管分配的其他相關任務 崗位要求： 1.細心、負責、願意配合團隊 2. 具有基本英文讀寫能力 3. MS Office skills 4. 大專(以上)畢業

Administrative Support for PMs: • Support finance-related tasks such as budget tracking, invoice coordination, and application of project-related expenses and vendor invoices • Track and manage sample-related queries • Set up projects in Lab LIMS system • Assist with bio-sample import/export permit applications • Support Trial Master File (TMF) management and organization • Take meeting minutes and follow up on action items • Handle project-related document stamping and signature application processes • Assist in project documents for drafting or quality control (QC) • Facilitate internal communication and coordination across departments for project needs • Execute other ad hoc tasks assigned by supervisors Basic Project Coordination: • Manage assigned basic-level projects under supervision • Ensure project delivery aligns with agreed timelines, scope, and quality standards • Maintain clear and timely communication with internal teams and external clients • Support project tracking and reporting activities Qualifications: • Bachelor’s degree or equivalent in Science, Medical, or related field • 1–2 years of experience in laboratory operations, clinical trials, or administrative coordination preferred Skills and Competencies: • Familiarity with laboratory workflows and basic project management principles • Detail-oriented, organized, and proactive in task execution • Strong communication and interpersonal skills; English proficiency is a plus • Ability to manage multiple tasks and prioritize effectively • Proficient in MS Office and comfortable working with lab systems (e.g., STARLIMS) • Basic understanding of finance processes and document control in a regulated environment

Job Summary As a member of the Central Lab team, you will be primarily responsible for the development, optimization, validation, and testing of Potency Assays based on cellular and immunological principles, as well as ELISA, cell culture, and functional assays. You will help define validation requirements and establish compliant processes under the supervision of the line manager, enabling the Central Lab to successfully develop, validate, and deliver high-quality assays to support clinical trials and regulatory submissions. This role also offers the opportunity to closely collaborate with clinical trial teams as you define and execute the start-up activities required to establish these assay capabilities and technical expertise within the Central Lab. You will lead or contribute to method development, optimization, validation, and transfer of assays, including cell-based functional assays, ELISA, and other immunoassays, while ensuring full GLP compliance. The role involves performing mammalian cell culture, advanced analytical techniques (e.g., Flow Cytometry, qPCR/dPCR), and driving method transfer and validation from external partners. Additionally, you will be responsible for supporting computer system validation, ensuring data integrity, audit readiness, and regulatory compliance across lab operations. General Responsibilities: 1. Collaborate with external groups to identify technology, method evaluation and business processes that will establish potency assay expertise at Central lab. 2. Conduct analytical testing in compliance with established SOPs and relevant guidance. 3. Review data and evaluate against established acceptance criteria. 4. Define requirements for laboratory equipment and support purchasing. 5. Evaluate data to identify trends and/or establish limits. 6. Participant in discrepancy investigations and corrective actions. 7. Provide training to department team member, especially in potency assay techniques. 8. Lead assay development, optimization, transfer and validation activities. 9. Write, review or approve equipment qualification/maintenance life cycle documents. 10.Draft, check, review documents, such as SOP, protocol, analytical result, report and method under limited supervision. 11.Support internal, external, and regulatory inspections. 12.Other tasks assigned by line manager. Qualifications: Education and Experience: 1. Master’s degree in Biotechnology, Biochemistry, Pharmaceutical Sciences, Laboratory Science, or related field. 2. 3+ years of experience in potency assay, ELISA, and/or cell-based assay development, preferably from CDMO, CMO, CRO, or GMP-regulated laboratories. 3. Familiarity with assay development for vaccines, biologics, ADC, or cell therapies is a plus. 4. With direct experience in flow cytometry method development is preferred. 5. Demonstrated ability to apply knowledge of potency assay theories, principles, and techniques. 6. Medical technologist license is a plus, but not required. Skills and Competencies:  Strong expertise in assay validation, method lifecycle management, and data analysis.  Familiarity with clinical trial lab operations and regulatory compliance.  Excellent documentation skills for regulated environments.  Effective communication and collaboration with cross-functional teams and clients.  Strong troubleshooting and problem-solving abilities.  Good verbal and written communication in English.  Ability to manage multiple priorities and meet deadlines in a dynamic CRO setting.

職責範圍: 1. 主要工作: 負責檢體的接收、清點、標籤與核 對，並確保檢體資訊的準確輸入至系統中，以及檢體的有效分發。 2. 次要工作: 協助組裝與檢查採檢套組，確保品質管控。 3. 文件管理: 負責案件檢體管理相關文件的掃描與歸檔。 4. 環境維護: 保持檢體管理區域的整潔與有序。 5. 團隊協作: 完成主管分配的其他相關任務。 尋人方向: 1. 細心與耐心 2. 有責任感 3. 基本的英語能力 4. 團隊合作精神 5. 科學或生物、化學相關科系背景 6. 大專(以上)畢業

Brief Position Description: The Site Management Associate (SMA) is responsible for planning, directing, and managing clinical trials at site. The SMA also implements remote site management activities according to the Site Management Plan, ensuring that clinical trials are conducted and documented, as per protocol, ICH GCP guidelines and applicable regulatory requirements and SOPs. 工作內容: 1. 協助醫師執行臨床試驗計畫 2. 完成資料及試驗數據之收集、記錄 3. 有研究護理師經驗者佳 4. 計畫及管理臨床試驗 5. 執行試驗場地管理 (依據試驗場地管理計畫) 6. 確保臨床試驗的執行及紀錄，是依據ICH GCP準則、本地及全球性的法規要求、諾佛葛及試驗場地的標準作業程序 Reporting to: As indicated on current organisation chart. Responsibilities: Conduct and complete remote site management activities and/or on-site visits according to the Site Management Plan. Specific duties include: Serve as a primary point of contact for site communication. Implement study start-up activities including but not limited to gathering feasibility information, negotiation of contract and budgets, planning for subject recruitment, communication with IRB/IEC. Collaborate with the principal investigator to prepare IRB/IEC and any other regulatory submission documents as required per protocol, ICH-GCP and local regulations. Ensure amendments to an approved protocol, informed consent form, and other relevant documents are submitted to IRB/IEC for approval as required and assure that changes are not implemented prior to approval. Arrange with monitor the scheduled date, time and location of site initiation visit. Prior to the site initiation visit, review the Investigator's Brochure and any up-to-date information on the investigational product for assessment of risk/benefit ratio of study participation in order to set Site Management Service Plan. Perform study-related tasks delegated by the principal investigator within the contracted scope. SMA is responsible for performing tasks appropriate for its role, unless otherwise noted on a protocol specific delegation of authority log. Support the investigator to identify suitable subjects for screening according to the eligibility criteria. If necessary, assist the principal investigator to use directed and IRB/IEC approved advertising (newspaper, TV, Internet advertisements, posters, etc.) materials. Provide written and verbal site updates on study progress to the line manger according to the study requirements/timelines. Ensure adequacy of information and data contained in site visit reports and other site management documents. Manage the site expenses of clinical trial including but not limited to subject reimbursement, material cost, travelling expense, cost for technical information, utilities and fees.

Please do submit English resume via our company website. https://fa-euzi-saasfaprod1.fa.ocs.oraclecloud.com/hcmUI/CandidateExperience/en/sites/CX_1/job/2284?utm_medium=jobboard Reporting to: Lab Director, or Lab Manager Position Description: The Researcher is responsible for the conduct of analysis related works according to GCP, GLP, CAP, Standard Operating Procedures (SOP), applicable Study Specific Procedures (SSP), and local regulatory requirements. The report writer/QC is responsible for writing correspond study report/method according to study plan and Standard Operating Procedures (SOP). And to perform the quality control works. Responsibilities: General Responsibilities • Conduct analysis work following related SOPs and guidance. • Draft/check/review/approve documents, such as SOP, protocol, analytical result, report and method. • Involve in lab logistics (general affair) management, such as purchasing, inventory controlling, payment applying. • Responsible for instrument maintenances, workspace cleaning/maintenance. • Delegated /assigned as the system owner for computerized system, do the corresponding work for system, such as validation test, periodic review, report, etc. • Participate in CAP/GCP/GLP/ regulatory related training courses. • Provide temporary supporting assigned by line manager. • Refer to additional Study Based Responsibilities while being assigned in analytical project. • Involve in sample collection kit/label preparation. • Involve in analytical study project management. • Other tasks assigned by line manager. Study Based Responsibility (if needed) Study Personnel in Study • All personnel involved in the conduct of the study must be knowledgeable in those parts of the Principles of Good Laboratory Practice which are applicable to their involvement in the study. • Study personnel will have access to the study plan and appropriate Standard Operating Procedures applicable to their involvement in the study. It is their responsibility to comply with the instructions given in these documents. Any deviation from these instructions should be documented and communicated directly to the Study Director, and/or if appropriate, the Principal Investigator(s). • All study personnel are responsible for recording raw data promptly and accurately and in compliance with these Principles of Good Laboratory Practice, and are responsible for the quality of their data. • Study personnel should exercise health precautions to minimize risk to themselves and to ensure the integrity of the study. They should communicate to the appropriate person any relevant known health or medical condition in order that they can be excluded from operations that may affect the study. Report Writer/Quality Control • As QC person, check and review the study data, document, report. • Involve in reference compound management, such as planning, shipping, receiving, using, storing, and disposing. And as the backup of sample manager. Qualifications: Education and Experience: • Secondary Technical school, Junior colleague, BS (Bachelor of Science) degree in Biochemistry, Biotechnology and Laboratory Science, Chemistry, or a related field. Advanced degree is a plus for Associate Researcher/ Senior Researcher. • License of Medical Technician is required for Associate Researcher/ Senior Researcher in Central Lab. Skills and Competencies: • Familiar with all lab operation activities. • Good working knowledge of CAP/GCP/GLP, applicable law (local and country) and regulatory requirements. • Good communication skills. • Good verbal and written English or other second language skills. • Good problem-solving skills. • Effective time management and prioritization skills.

Please do submit English resume to our company website. https://fa-euzi-saasfaprod1.fa.ocs.oraclecloud.com/hcmUI/CandidateExperience/en/sites/CX_1/job/3388/?utm_medium=jobshare&utm_source=External+Job+Share Clinical Research Associate II - Clinical Research Associate III - Senior CRA Position Description: The Clinical Research Associate (CRA) is primarily responsible for ensuring the rights and wellbeing of trial participants are protected and the reported trial data are accurate, complete, and verifiable from the source documents. The CRA is the primary contact between the Investigational Sites, Novotech, and Sponsor. Key responsibility of a CRA is as a site relationship manager ensuring that clinical trials are conducted in accordance with ICH GCP guidelines, local and global regulatory requirements, and Novotech/Client SOPs. Responsibilities: •CRAs primary responsibility is to build relationships with Principal Investigators, study coordinators, pharmacists, and all relevant site trial personnel to ensure the efficient, expedited, and smooth management of clinical trials. •In collaboration with IHCRA or DMA team, ensure the project Trial Master File (TMF) is up to date, current and complete always throughout duration of the study. •Monitoring of investigational sites as per ICH GCP §5.18 (Monitoring) and the Clinical Monitoring Plan (CMP) for each study. This includes all monitoring visit types across all phases of a clinical trial including Site Selection, Site Initiation, Site Monitoring and Site Close Out, unblinded pharmacy visits, and co-monitoring visits. Visits can be conducted either onsite or remote as per CMP. •Responsible for learning the company culture, policies, and procedures through specialized training called CRA II fast track training program including observational visits for all types of visits (if applicable) and on the job training by supporting the day-to-day CRA activities of clinical project team members such as CRAs and Line managers (LMs). •Provide written and verbal site updates (including monitoring visit reports) on study progress to the PM/LCRA according to the study requirements/timelines as documented in the Clinical Monitoring Plan and Sponsor/Novotech SOPs. Escalate all key issues as per Issue Escalation SOP.

Please do submit English resume to our company website. https://fa-euzi-saasfaprod1.fa.ocs.oraclecloud.com/hcmUI/CandidateExperience/en/sites/CX_1/job/2683/?utm_medium=jobshare Brief Position Description: The Study Nurse is responsible for planning, directing, and managing clinical trials at site. The Study Nurse also implements remote site management activities according to the Site Management Plan, ensuring that clinical trials are conducted and documented, as per protocol, ICH GCP guidelines and applicable regulatory requirements and SOPs. Reporting to: As indicated on current organisation chart. Responsibilities: Conduct and complete remote site management activities and/or on-site visits according to the Site Management Plan. Specific duties include: Serve as a primary point of contact for site communication. Implement study start-up activities including but not limited to gathering feasibility information, negotiation of contract and budgets, planning for subject recruitment, communication with IRB/IEC. Collaborate with the principal investigator to prepare IRB/IEC and any other regulatory submission documents as required per protocol, ICH-GCP and local regulations. Ensure amendments to an approved protocol, informed consent form, and other relevant documents are submitted to IRB/IEC for approval as required and assure that changes are not implemented prior to approval. Arrange with monitor the scheduled date, time and location of site initiation visit. Prior to the site initiation visit, review the Investigator's Brochure and any up-to-date information on the investigational product for assessment of risk/benefit ratio of study participation in order to set Site Management Service Plan. Perform study-related tasks delegated by the principal investigator within the contracted scope. Study Nurse is responsible for performing tasks appropriate for its role, unless otherwise noted on a protocol specific delegation of authority log. Support the investigator to identify suitable subjects for screening according to the eligibility criteria. If necessary, assist the principal investigator to use directed and IRB/IEC approved advertising (newspaper, TV, Internet advertisements, posters, etc.) materials. Provide written and verbal site updates on study progress to the line manger according to the study requirements/timelines. Ensure adequacy of information and data contained in site visit reports and other site management documents. Manage the site expenses of clinical trial including but not limited to subject reimbursement, material cost, travelling expense, cost for technical information, utilities and fees.

Position description: Lead the team to assist PI to administer and coordinate the clinical study projects in accordance with Protocol and SOPs to ensure that the procedures and quality of clinical trials are in compliance with GCP guidelines. Responsibilities: 1) Lead the team in Clinical Pharmacology Unit to execute the clinical trials in accordance with Protocol, SOP and in compliance with GCP guidelines and local regulation. 2) Perform any responsibilities of assigned team members in all capacity, as appropriate. This may include, without limitation, performing site visit, subject screening, Investigative Site File (ISF) management, Adverse Event management, study conduct, sample preparation, subject health status monitoring and follow up, etc., in accordance with assigned team members’ job descriptions. 3) Manage assigned team’s resource and provide periodic analytic resource forecast to the management. May be involved in hiring process. 4) Provide necessary training to assigned team members and ensures team’s training requirements and qualifications are met. 5) Manage Key Performance Indicators (KPI) are met and achieves goals set by the organization for the assigned team and individuals within the assigned team. 6) Manage and build relationship with internal/external stakeholders. This may include, without limitation, direct client facing activities, participation in internal/external meetings, vendor management, investigator/site staff management etc. 7) Lead audit and/or inspection activities and provide necessary level of support to assigned team and projects. 8) Ensure the study team’s work environment is safe and adequate to perform assigned tasks i.e., access control, safety equipment, pest control etc. 9) May be assigned to any other temporary tasks as required by the organization. Qualifications: Education and Experience: 1) Bachelor or college degree of nursing, pharmacy, or medical related profession 2) year or above working experience in clinical research industry is a plus Skills and Competencies: 1) Good knowledge of GCP 2) Communication skill 3) Project management concept

職責範圍: 1. 主要工作: 負責檢體的接收、清點、標籤與核對，並確保檢體資訊的準確輸入至系統中，以及檢體的有效分發。 2. 次要工作: 協助組裝與檢查採檢套組，確保品質管控。 3. 文件管理: 負責案件檢體管理相關文件的掃描與歸檔。 4. 環境維護: 保持檢體管理區域的整潔與有序。 5. 團隊協作: 完成主管分配的其他相關任務。 尋人方向: 1. 細心與耐心 2. 有責任感 3. 基本的英語能力 4. 團隊合作精神

品質保證單位之職責及工作內容: - 維持GLP實驗室品保部門的運作。 - 負責稽查GLP 試驗計畫之執行過程，以確保其設施、設備、儀器、人員、試驗方法、各項管制及紀錄等符合法規範要求。 - 撰寫或審核品保部門SOP以確保符合法規範要求。 -負責客戶稽核以及法規機關查核應對以及後續矯正措施的追蹤。 -進行委外供應商定期稽核。 -負責主管交辦事項 專業背景： - 醫學、藥學、生命科學相關專業本科及以上學歷； - 至少1年生技醫藥行業相關經驗，有GLP,GCP或CAP體系相關經驗者優先； - 具備扎實的GLP理論與實踐經驗，瞭解臨床試驗法規與規範；