Clinical Research Associate

2 weeks ago


กรงเทพมหานคร, Thailand Thermo Fisher Scientific Full time

Job DescriptionAt Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner, and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development, and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future
- A day in the Life:
- Communicate the progress and information or raise issues to the study management team.
- Accountable for activities required in set up and for quality execution of studies
- Performs site evaluation visits, study initiation visits, and monitoring visits at the frequency and site visits.
- Determines the feasibility of the study protocol with reference to study complexity.
- Confirms staff availability, facilities, for per protocol patient population.
- Confirms ability to align with ICH GCP and Client requirements for clinical studies and works with Client Study staff to carry out a study / site level risk assessment.
- Delivers training to site staff and parties, as the need arises. Assists with web based and face to face Client trainings to ensure that investigators and site staff are appropriately trained in ICH GCP and study related procedures so that they can effectively be responsible for the study.
- Participate in global investigators and/or supervise meetings. Facilitates investigator’s participation in global meetings and/or may assist the Client study staff with organizing investigator meetings. Participates in study meetings as required.
- Maintain relationship with sites and ensure that study timelines related to monitoring activities are achieved and that recruitment targets, patient recruitment cycle times, data and audit quality and site related achievements are met.
- Ensure that investigators and staff fully understand their roles and responsibilities with respect to requirements (ICH-GCP).
- Work with the sites to ensure they address data queries in a timely manner. Verifying that data entered into the CRFs is consistent with patient medical notes and entered in real time.
- Ensure Investigator and site staff receives safety reports and new safety information in a timely manner.
- Ensure the accuracy of data collected for safety reporting (AEs, SAEs etc.), and provides such information to relevant departments, within the required time frames.
- Completes supervising visit reports within the agreed timelines.
- Ensure local and global clinical study tracking databases are kept current with clinical study information as required.
- Ensure all vital study supplies are available at sites in a timely manner and appropriate accountability is maintained during the study. Ensure all unused study supplies are accounted for and destroyed appropriately.
- Ensure sponsor study records are inspection ready at all times and archives records as applicable.
- Experience and Skills- Strong written and verbal communication skills in English and local language (if applicable), good presentation, negotiation and influencing skills.
- Able to work within remote teams and independently.
- Ability to effectively manage multiple priorities and responsibilities of increasing scope and complexity.
- Good interpersonal skills.
- Strong planning & organizational skills, and the ability to work efficiently and effectively in a dynamic environment.
- Respects confidentiality.
- Proactive, conscientious and precise in delivery of quality work even when under pressure
- Effective at analyzing and escalating issues at the right functional level, solving problems and resolving conflicts in a timely manner.
- Flexible with high learning and change agility.
- Collaborative, building strong internal and external relationships.
- Knowledge of local regulations, IND/ICH GCP - guidelines.
- Available and willing to travel as job requires.
- Strong computer skills with good eye for detail.



  • กรุงเทพมหานคร, Thailand Novotech Asia Full time

    **Minimum Qualifications & Experience**: Graduate in a clinical or life sciences-related field. Relevant experience/qualifications in allied professions may also be considered. Must have good time management skills, attention to detail, be able to work well in a team, and be computer literate. Preferably experience of working in the research, pharmaceutical...


  • กรุงเทพมหานคร, Thailand MSD (THAILAND) LTD. Full time

    Develops strong site relationships and ensures continuity of site relationships through all phases of the trial. Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents. Gains an in-depth understanding of the study protocol and...


  • กรุงเทพมหานคร, Thailand AstraZeneca Full time

    **About the job** The Clinical Research Associate has local responsibility for the delivery of the studies at allocated centers and is active in ensuring that quality and quantity commitments are achieved in a timely and efficient manner. **Major responsibilities** - Set up, initiated, monitored, closed and documentation archived of clinical studies -...


  • กรุงเทพมหานคร, Thailand MSD (THAILAND) LTD. Full time

    Develops strong site relationships and ensures continuity of site relationships through all phases of the trial. Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents. Gains an in-depth understanding of the study protocol and...


  • กรุงเทพมหานคร, Thailand MSD (THAILAND) LTD. Full time

    Develops strong site relationships and ensures continuity of site relationships through all phases of the trial. Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents. Gains an in-depth understanding of the study protocol and...


  • สาทร, กรุงเทพมหานคร, Thailand PRTR Full time

    More than just a recruitment company. At PRTR, we have been a part of our customer's success for 30 years as their total HR solutions partner. With 550 dedicated professionals and over 15,000 outsourced staff, we will continue to carry out our mission to develop a better career, a better life, and a better society, and thrive to become the No.1 people...


  • กรุงเทพมหานคร, Thailand AstraZeneca Full time

    **About the job** The Senior Clinical Research Associate has local responsibility for the delivery of the studies at allocated centers and is active in ensuring that quality and quantity commitments are achieved in a timely and efficient manner. **Major responsibilities** - Set up, initiated, monitored, closed and documentation archived of clinical...


  • กรุงเทพมหานคร, Thailand MSD Full time

    **Job Description**: **THE OPPORTUNITY** 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, Merck policies and procedures, quality standards and adverse event reporting requirements...


  • กรุงเทพมหานคร, Thailand MSD (THAILAND) LTD. Full time

    Develops strong site relationships and ensures continuity of site relationships through all phases of the trial. Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents. Gains an in-depth understanding of the study protocol and...


  • กรุงเทพมหานคร, Thailand MSD (THAILAND) LTD. Full time

    Develops strong site relationships and ensures continuity of site relationships through all phases of the trial. Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents. Gains an in-depth understanding of the study protocol and...


  • กรุงเทพมหานคร, Thailand Monroe Consulting Group Full time

    **Senior Clinical Research Associate I (Health), Bangkok**: - **Sector**: Monroe Health - **Contact**: Joh - Sakdihot - **Location**: Bangkok - **Salary**: Up to THB180000 per month - **Expiry Date**: 03 November 2023 - **Job Ref**: BBBH429223_1691201847 Award-winning executive recruitment company, Monroe Consulting Group Thailand is recruiting on behalf...


  • กรุงเทพมหานคร, Thailand MSD Full time

    **Clinical Research Associate Manager** **THE OPPORTUNITY** This role will be key to ensure strong monitoring in our clinical trials. Under the oversight of the Head of Monitoring Resources or the CRD, the person is responsible to manage a team of 6-14 CRAs and to ensure excellent study and site performance with strict adherence to local regulations,...

  • Research Nurse

    4 weeks ago


    ปทุมวัน, กรุงเทพมหานคร, Thailand มูลนิธิสถาบันเพื่อการวิจัยและนวัตกรรมด้านเอชไอวี Full time

    องค์กรการกุศล วันนี้ - คุณสมบัติพื้นฐาน - งานประจำ- 3 - 5 ปี- กทม. (ปทุมวัน)- ปริญญาตรี- สามารถเจรจาต่อรองได้- หน้าที่และความรับผิดชอบ -...


  • กรุงเทพมหานคร, Thailand Fortrea Full time

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...


  • กรุงเทพมหานคร, Thailand 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...


  • กรุงเทพมหานคร, Thailand MSD Full time

    With support of other CRMs and/or TA-Head/CRD, this role is accountable for the end-to-end performance and project management for assigned protocols in a country in compliance with ICH/GCP and country regulations, the company's policies and procedures, quality standards and adverse event reporting requirements internally and externally. The aCRM could be...


  • กรุงเทพมหานคร, Thailand MSD (THAILAND) LTD. Full time

    Work allocation, staff development and performance appraisal. Provides input for capacity planning, including reporting of current manpower and forecasting of CRA capacity and needs, to provide efficient use of resources. Work with CRAs, PLMS and other functions to ensure consistency of processes and protocol implementation across the country, to reduce...


  • กรุงเทพมหานคร, Thailand Grand Pacific CRO Full time

    **About Us**: **The Grand Pacific CRO** team has over 25 years’ experience in conducting clinical trials in the Asia Pacific region, including Australia, New Zealand and South Africa. We have continued as a leader in the industry and have expanded services to include central laboratory, site management and image reading services. We pride ourselves on...


  • กรุงเทพมหานคร, Thailand 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...


  • กรุงเทพมหานคร, Thailand Novasyte Full time

    Essential Functions - Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines - Administer protocol and related study training to assigned sites and...