Clinical Research Associate

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...

**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 -...

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...

**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...

**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...

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...

**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...

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...

Essential Job Duties: 1) 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; liaise with vendors; and other duties, as assigned 2) Responsible for all aspects of site management as prescribed in the project plans 3) General...

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. -...

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...

**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...

Track (e.g. essential documents) and report (e.g. Safety Reports). Update clinical trial databases (CTMS) and trackers. Ensure collation and distribution of study tools and documents. Clinical supply & non-clinical supply management, in collaboration with other country roles. Manage Labeling requirements and coordinate/sign translation change request, in...

**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...