Senior Clinical Research Associate 1

6 months ago


Hanoi, Vietnam IQVIA Full time

Job Overview
Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.

Essential Functions
- Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and Good Clinical Practice.
- Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
- Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
- Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
- Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
- Collaborate and liaise with study team members for project execution support as appropriate.
- If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.

**Qualifications**:

- Bachelor's Degree Degree in scientific discipline or health care preferred. Req
- Requires at least 2 years of year of on-site monitoring experience. Req
- Equivalent combination of education, training and experience may be accepted in lieu of degree. Req
- Good knowledge of, and skill in applying, applicable clinical research regulatory requirements.
- i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Good therapeutic and protocol knowledge as provided in company training.
- Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
- Written and verbal communication skills including good command of English language.
- Organizational and problem-solving skills.
- Effective time and financial management skills.
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients.



  • Hanoi, Vietnam Novasyte Full time

    Job Overview Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements. Essential Functions - Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance...


  • Hanoi, Vietnam MSD Full time

    **Job Description**: The role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA manager the person ensures compliance of study conduct with ICH/GCP and country regulations, Our company policies and procedures, quality standards and adverse event reporting requirements internally and...


  • Hanoi, Vietnam CIAT Full time

    **The Organization** The Alliance of Bioversity International and CIAT delivers research-based solutions that harness agricultural biodiversity and sustainably transform food systems to improve people’s lives. Alliance solutions address the global crises of malnutrition, climate change, biodiversity loss, and environmental degradation. The Alliance works...


  • Hanoi, Vietnam Oxford University Clinical Research Unit - Vietnam Full time

    **Mô tả công việc**: (Mức lương: Thỏa thuận) The post is responsible for the day-to-day operations of the IT activities in the Oxford University Clinical Research Unit - Ha Noi. He/she is also responsible for managing all servers, computers, printers, internet service, networking devices, and backup services by coordinating with IT Teams in...


  • Hanoi, Vietnam AlignTech Full time

    **Join a team that is changing millions of lives.** Transforming smiles, changing lives. At Align Technology, we believe a great smile can transform a person’s life, so we create technology that gives people the confidence to take on whatever’s next. We revolutionized the orthodontic industry with the introduction of the Invisalign system, and we have...


  • Hanoi, Vietnam MSD Full time

    **Job Description**: This role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, Our Company policies and procedures, quality standards and adverse event reporting requirements internally and externally. Under the oversight of the Sr. COM, Head COMs or CRD, the person is...


  • Hanoi, Vietnam Mekong Capital Full time

    **The Why**: - Mekong Capitals purpose is reinventing Private Equity. We are looking for a new Associate or Senior Associate in the Transaction Team to cause breakthroughs in identifying, structuring, and completing investments at Mekong Capital. - Join us if you are passionate about hunting to find the opportunities that best fit our approach and model of...

  • Research Associate

    7 months ago


    Hanoi, Vietnam CIAT Full time

    **The Organization** The Alliance of Bioversity International delivers research-based solutions that harness agricultural biodiversity and sustainably transform food systems to improve people’s lives. Alliance solutions address the global crises of malnutrition, climate change, biodiversity loss, and environmental degradation. The Alliance works with...


  • Hanoi, Vietnam Align Recruitment Full time

    **Posting** ** AR-199 **Title** **Consultant Rheumatologist & Clinical Medical Director - Hanoi, Vietnam - AR-199**: **City** ** Hanoi **Country** ** Vietnam **Profession** ** Rheumatology **Job Type** ** Permanent Full-Time **Relocation** ** Yes **Salary** ** US$8,000 to $9,000 per month net after taxes paid by the employer **Start Date** **...


  • Hanoi, Vietnam USAID Learns - Social Impact Full time

    **(SENIOR) RESEARCH SPECIALIST** USAID Learns Contract Hanoi, Vietnam **About Social Impact**: Social Impact (SI) is a global development management consulting firm. We provide monitoring, evaluation, strategic planning, and capacity-building services to advance development effectiveness. We work across all development sectors including democracy and...


  • Hanoi, Vietnam Social Impact Full time

    **(SENIOR) RESEARCH SPECIALIST** USAID Learns Contract Hanoi, Vietnam **About Social Impact**: Social Impact (SI) is a global development management consulting firm. We provide monitoring, evaluation, strategic planning, and capacity-building services to advance development effectiveness. We work across all development sectors including democracy and...


  • Hanoi, Vietnam USAID Learns - Social Impact Full time

    **(SENIOR) RESEARCH SPECIALIST** USAID Learns Contract Hanoi, Vietnam **About Social Impact**: Social Impact (SI) is a global development management consulting firm. We provide monitoring, evaluation, strategic planning, and capacity-building services to advance development effectiveness. We work across all development sectors including democracy and...


  • Hanoi, Vietnam Vialto Partners Full time

    Company Description At Vialto we create the connections that build global careers and societies, bridging the gap between people and their aspirations. As the world of work continues to evolve, we are bringing together the individuals, ideas and technology to unlock business and human growth. **Job Description**: Vialto Partners Professional skills and...


  • Hanoi, Vietnam Kroll Full time

    **Senior Associate, Compliance Consulting, Hanoi, Vietnam** In a world of disruption and increasingly complex business challenges, our professionals bring truth into focus with the Kroll Lens. Paired with the latest technology, allow us to give our clients clarity—not just answers—in all areas of business. We embrace diverse backgrounds and global...

  • Senior Associate

    1 day ago


    Hanoi, Vietnam aon vietnam ltd Full time

    Xem và nộp hồ sơ ngay **Lưu ý**: - Người tìm việc đang xem tin **Senior Associate - Client Management**: - **Mã tin đăng: 3451806**. Mọi thông tin liên quan tới tin tuyển dụng này là do người đăng tin đăng tải và chịu trách nhiệm. Chúng tôi luôn cố gắng để có chất lượng thông tin tốt nhất,...


  • Hanoi, Vietnam NavigosSearch Full time

    **What We Can Offer**: The Environmental Specialist is responsible for undertaking varied consultancy tasks of reasonable scope and complexity with some direction and guidance from more senior staff team members, including Technical Principal - Environment and Associate Principal. The holder of this position provides broad technical knowledge in the...


  • Hanoi, Vietnam IRRI Education Full time

    **About IRRI** The Initiative “Nature+: Nature-positive solutions for shifting agri-food systems to more resilient and sustainable pathways”, developed by CGIAR scientists and partners, is a ten-year programme which aims at integrating agri - food production systems with innovative nature-positive solutions to cope with climate change and the depletion...

  • Associate, Tax

    7 months ago


    Hanoi, Vietnam Vialto Partners Full time

    Associate, Tax **Company Description** Vialto Partners is a market leader in global mobility services. Our purpose is to 'Connect the world'. We are unique and the only stand-alone global mobility business. This presents a rare opportunity for our clients, stakeholders and colleagues. Our teams help companies streamline and effectively manage their global...


  • Hanoi, Vietnam NavigosSearch Full time

    **What We Can Offer**: The Environmental Specialist is responsible for undertaking varied consultancy tasks of reasonable scope and complexity with some direction and guidance from more senior staff team members, including Technical Principal - Environment and Associate Principal. The holder of this position provides broad technical knowledge in the...


  • Hanoi, Vietnam Dragon Capital Full time

    **Position**: Senior Associate, Partnership Distribution **Department**: Domestic Asset Management **No. of vacancy**: 1 **Work location**: 1 person in HCMC, 1 person in Ha Noi Key Responsibilities Handle all sales activities on assigned channels. Monitor information on the assigned business channels and report to the Sales Director. Provide effective...