Clinical Research Associate 2

2 weeks ago


กรงเทพมหานคร, 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 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.
- Requires at least 1 year of on-site monitoring experience.
- Equivalent combination of education, training and experience may be accepted in lieu of degree.
- 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.



  • 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...


  • คลองเตย, กรุงเทพมหานคร, Thailand PRTR Full time

    Our client is a global pharmaceutical company. They are looking for a Clinical Research Associate to join their team. **Responsibilities** - Functioning as project lead for complex BE/Phase I studies and small patient PK/clinical endpoint studies. Serve as liaison between the Mylan project team (Global Pharmacology, Product Development Department Chemistry...


  • 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 AstraZeneca Full time

    The Clinical Research Associate (CRA) is responsible for delivering the studies at allocated centers and actively ensures 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 at study...


  • 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 Full time

    **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 internally and...


  • กรุงเทพมหานคร, Thailand MSD Full time

    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 policies and procedures, quality standards and adverse event reporting requirements internally and externally. Acts as primary...


  • กรุงเทพมหานคร, Thailand MSD Full time

    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, policies and procedures, quality standards and adverse event reporting requirements internally and externally. Acts as primary site...


  • 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 Full time

    With support of SrCRA/CRA and/or CRA Manager, acts as primary site contact and site manager throughout all phases of a clinical research study, taking responsibility of allocated sites. **Description of Position** - Develops strong site relationships and ensures continuity of site relationships through all phases of the trial. - Performs clinical study site...


  • 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 Novotech Asia Full time

    **Brief Position Description**: The Inhouse Clinical Research Associate (IHCRA) provides in-house support to the clinical team according to project requirements, ICH GCP guidelines, local or global regulatory requirements and Novotech or Client SOPs. **Reporting to**: As indicated on current organisation chart. **Minimum Qualifications & Experience**: -...


  • 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...


  • กรุงเทพมหานคร, Thailand MSD Full time

    **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 internally and...


  • 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 Full time

    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 internally and externally. Acts as primary...


  • กรุงเทพมหานคร, Thailand Parexel Full time

    Everything we do has the potential to impact patient lives, and our Clinical Research Associates (CRAs) take their work seriously, demonstrate empathy, and act with heart. They also perform with urgency, navigating our streamlined clinical operating model to drive effectiveness, reduce handoffs and increase employee, client and site satisfaction. As a CRA...


  • กรุงเทพมหานคร, Thailand Parexel Full time

    Everything we do has the potential to impact patient lives, and our Clinical Research Associates (CRAs) take their work seriously, demonstrate empathy, and act with heart. They also perform with urgency, navigating our streamlined clinical operating model to drive effectiveness, reduce handoffs and increase employee, client and site satisfaction. As a CRA...


  • 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...