Clinical Research Associate I

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...

**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...

**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...

**Essential Job Duties**: - Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits, with or without guidance (as per the training status of the CRAI-MEA); liaise with vendors; and other duties, as assigned - Responsible for...

Essential Functions: - Monitors investigator sites with a risk-based monitoring approach applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable...

**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...

**Job Overview** Perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery. Essential Functions - Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining...

This position is responsible for project management of the assigned studies, accountable for performance for assigned protocols, leads local study teams to high performance on trains in the protocol other local roles, closely collaborates with and supports CRAs as protocol expert etc. **WHAT YOU WILL DO** **Key Responsibilities**: - Main Point of Contact...

**Job Description**: This position is responsible for project management of the assigned studies, accountable for performance for assigned protocols, leads local study teams to high performance on trains in the protocol other local roles, closely collaborates with and supports CRAs as protocol expert etc. **WHAT YOU WILL DO** **Key Responsibilities**: -...

**About the Department** Novo Nordisk is a global healthcare company with more than 95 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat obesity, haemophilia, growth disorders and other serious chronic diseases. Headquartered in Denmark, Novo Nordisk employs...

บริษัท: - ศูนย์ประสานความร่วมมือระหว่างไทย-ออสเตรเลีย-เนเธอร์แลนด์ เพื่อการศึกษาวิจัยทางคลินิกด้านโรคเอดส์ - รายละเอียดงาน: - Reviews...

**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. -...

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

Job Duties: - Has regulatory oversight of direct reports by ensuring regulatory training is executed, understood and implemented - Escalate issues and follow them till proper resolution - Ensures training record compliance with training matrix and ensures training records are up to date - Provide input to relevant SOPs and standard plans/templates when...

**Brief Position Description**: **Minimum Qualifications & Experience: - Degree in a related field; computer science, information technology and/or information systems. - Experience in clinical trial systems supporting the CRO and/or pharmaceutical industry is required **Responsibilities: - Primary liaison with vendors and Novotech IT for maintenance...

At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery,...

Clinical supply and Non-clinical supply management (mainly focus on import and export activities), in collaboration with other country roles. Update clinical trial databases, report and trackers as required. Ensure collaboration and distribution of study tools and documents. Prepare documents and correspondence. Collate, distribute/ship, and archive clinical...

**Are you looking for an exciting next step in your career? Do you enjoy working on high profile global accounts within the FMCG industry?** We are looking for an energetic, self-motivated and passionate individual to join our small but growing team in Bangkok as a Project Manager. This an** associate level**position with a salary reflective of this, please...

This position is open to all APAC countries including AU and NZ. **Brief Position Description**: The Clinical Lead (CL) and Senior Clinical Lead provides direction and guidance to multi-country clinical teams in assigned project(s), coordinates site management and monitoring activities, and provides operational leadership for clinical teams to achieve...

We are sourcing for translators in Thailand -native Thai and native English. - **Please only send CVs in English.**: - **Translator/Linguist certificate will be required**: - **Work references will be required** **About us** We are specialists in multi-country studies and have a global reach, through our strategic regulatory, linguistic and research...