Cra (Level 1) - Fsp

5 days ago


กรงเทพมหานคร, Thailand Thermo Fisher Scientific Full time

**Work Schedule**

Standard Office Hours (40/wk)

**Environmental Conditions**

Office

**Job Description**:
At 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.

Our global Clinical Operations colleagues within our PPD® clinical research services provide end-to-end support for clinical trials from study start up to monitoring through to study close out, across commercial and government contracts. Together, we help clients define and develop clinical programs, minimize delays, and execute high-quality, cost-efficient clinical studies.

**Role-related 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.
- Proficient in optimally balancing multiple responsibilities of growing scope and complexity in a fast-paced environment.
- Good social skills.
- Strong planning & organizational skills, and the ability to work efficiently and effectively in a dynamic environment.
- Respects confidentiality in terms of PII.
- Proactive, meticulous and precise in delivery of quality work even when under pressure
- Effective at analyzing and raising 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
- Proficient in using computer systems and meticulous in attention to detail.

**Role responsibilities**
- Communicate the progress and relevant information or raise issues of the study to the appropriate study management team
- Engage in effective written and verbal communication with collaborators outside the organization to ensure successful study execution.
- Accountable for local activities required in set up and for high quality execution of studies; will seek managerial or other experienced support as appropriate:

- Performs operational site evaluation visits, study initiation visits, on and off-site monitoring visits at the required frequency and site close-out visits.
- Performs site evaluation visits:

- Figures out feasibility of the study protocol with reference to study complexity
- Confirms staff availability, suitable clinical facilities, potential for per protocol patient population. Shows the capability to follow ICH GCP and Client requirements for clinical research by conducting site visits and monitoring activities to assess adherence to protocol, regulatory requirements, and overall data integrity.
- Works with Client Study staff to carry out a local study / site level risk assessment.
- Delivers appropriate training to site staff and other relevant parties, as required. 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 run the clinical study.
- Participate in global investigators and/or supervise meetings as appropriate. Facilitates investigator’s participation in global meetings and/or may assist the Client study staff with organizing local investigator meetings. Participates in other study meetings as required.
- Maintain good relationship with sites and ensure that critical 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 regulatory 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 GCSP and other relevant departments, within the required time frames.
- Completes monitoring visit reports w


  • Assistant Cra

    7 days ago


    กรุงเทพมหานคร, Thailand Thermo Fisher Scientific Full time

    **Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Assistant CRA - Thailand** At 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...

  • Assistant Cra

    4 weeks ago


    กรุงเทพมหานคร, Thailand Thermo Fisher Scientific Full time

    **Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Assistant CRA - Thailand** At 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...

  • Cra Ii or Sr Cra

    3 months ago


    กรุงเทพมหานคร, Thailand Syneos - Clinical and Corporate - Prod Full time

    **Description** Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything...

  • Sr Cra I

    6 months ago


    กรุงเทพมหานคร, Thailand Syneos - Clinical and Corporate - Prod Full time

    **Description** **Senior Clinical Research Associate I** Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and...


  • กรุงเทพมหานคร, Thailand Foreign & Commonwealth Office Full time

    Job Description (Roles and Responsibilities) 1 **Main purpose of job**: The British Embassy Bangkok is a large diplomatic mission of around 140 staff delivering a dynamic and rapidly expanding programme of activity in support of the UK’s objectives including on prosperity, trade, security, open societies, consular services and law enforcement. This is an...


  • กรุงเทพมหานคร, Thailand Foreign & Commonwealth Office Full time

    Job Description (Roles and Responsibilities) **Main purpose of job**: The British Embassy Bangkok is a large diplomatic mission of around 140 staff delivering a dynamic and rapidly expanding programme of activity in support of the UK’s objectives including on prosperity, trade, security, open societies, consular services and law enforcement. This is an...

  • Associate Cra

    6 months ago


    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 and 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...

  • Associate Cra

    6 months ago


    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 and 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...

  • Associate Cra

    6 months ago


    กรุงเทพมหานคร, Thailand MSD Full time

    **WHAT YOU WILL DO** **Key Responsibilities**: - Develops strong site relationships and ensures continuity of site relationships through all phases of the trial. - Performs clinical study site management and monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents. -...


  • 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,...


  • กรุงเทพมหานคร, Thailand AccorCorpo Full time

    **Company Description** "Why work for Accor? We are far more than a worldwide leader. We welcome you as you are and you can find a job and brand that matches your personality. We support you to grow and learn every day, making sure that work brings purpose to your life, so that during your journey with us, you can continue to explore Accor’s limitless...


  • กรุงเทพมหานคร, Thailand IQVIA 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...


  • 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 AstraZeneca Full time

    **Job summary**: The Study Start-Up Manager (SSU Manager) is responsible at country level for managing and conducting start-up activities in compliance with the company procedures, documents, local and international guidelines such as ICH - GCP and relevant regulations. The SSU Manager will prepare, review, track and manage site regulatory documentation at...


  • กรุงเทพมหานคร, Thailand AstraZeneca Full time

    **Study Start-Up Manager** **Job Summary**: The Study Start-Up Manager (SSU Manager) is responsible at country level for managing and conducting start-up activities in compliance with the company procedures, documents, local and international guidelines such as ICH - GCP and relevant regulations. The SSU Manager will prepare, review, track and manage site...


  • กรุงเทพมหานคร, Thailand Shopee Full time

    Department Business Intelligence and Data Analytics- LevelExperienced (Individual Contributor)- LocationThailand - BangkokThe Business Intelligence and Data Analytics team plays a critical role in conducting close-loop data-driven business iterations. As business intelligence specialists and data analysts, our scope of work is not limited to just performance...


  • กรุงเทพมหานคร, Thailand PSI CRO Full time

    **Company Description** PSI is a leading clinical research services company with over 25 years of industry experience. We offer a wide range of clinical study services to many pharmaceutical and biotechnology companies. We maintain a perfect balance between stability and innovation for both our clients and our employees. We are constantly striving to combine...

  • Technical Service

    6 months ago


    ห้วยขวาง, กรุงเทพมหานคร, Thailand Reeracoen Thailand Full time

    **Overview**: **Salary**: 45,000 THB ~ 60,000 THB**Industry**: Manufacturing(Automotive)1. Organize and follow up of Field monitor tests in the ASEAN market 2. Handle the ASEAN market's claims and complains with an accurate response. 3. To analyze the market information and report the market demand and improvement request with actual evidence. 4. Leading or...


  • กรุงเทพมหานคร, Thailand AstraZeneca Full time

    The Clinical Research Associate (CRA) has responsibilities for the delivery of the studies at allocated centers and are active ensuring that quality and quantity commitments are achieved in a timely and efficient manner. **Major responsibilities** - Manage EC submission, Initiation, Monitoring and Closure of clinical studies - Proactive to drive recruitment...

  • Technical Service

    6 months ago


    กรุงเทพมหานคร, Thailand RGF Full time

    **Job Detail**: - Technical Service (Tire/Senior or Assistant Level) (45K-55K) (SDG-100661) - เจ้าหน้าที่อาวุโสหรือผู้ช่วยฝ่ายบริการด้านเทคนิค (ยาง)- - Organize and follow up of Field Monitor tests in the ASEAN market - Handle the ASEAN market's claims and...