Associate Cra
5 days ago
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 and related procedures.
Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.
Participates & provides inputs on site selection and validation activities.
Performs remote and on-site monitoring & oversight activities using various tools to ensure the data generated at site are complete, accurate and unbiased which Subjects' right, safety and well-being are protected.
Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.
Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.
Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRM, PLM and CCQM.
Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.
WHAT YOU MUST HAVE.
To be successful in this role, you will have strong technical skills as well as business capabilities. The requirements are as follows:
Bachelor of Sciences with strong emphasis in science and/or biology would be prefer.
Minimum 1 Years of clinical research experience which may include Clinical Trial Assistant, Study Coordinator, Regulatory CTC etc.
Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand technical information. Developing ability to present technical information with support.
Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.
Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
Developing skills in Site Management including management of site performance and patient recruitment which monitoring skill and independent professional judgment.
Able to work with other experienced research professions to develop skills across multiple protocols, sites and therapy areas.
High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment, with support from Line Manager.
Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.
Demonstrates commitment to Customer focus.
Search Firm Representatives Please Read Carefully
**Employee Status**:
Regular
**Relocation**:VISA Sponsorship**:Travel Requirements**:Flexible Work Arrangements**:
Not Applicable
**Shift**:Valid Driving License**:Hazardous Material(s)**:
**Requisition ID**: R266105.
**Job skills required**: Biology, English, Research, Compliance
-
Clinical Research Associate
4 weeks ago
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...
-
Associate Cra
3 weeks 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. -...
-
Associate Cra
3 weeks ago
กรุงเทพมหานคร, Thailand MSD (THAILAND) LTD. Full timeDevelops 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...
-
Cra Ii
4 weeks ago
กรุงเทพมหานคร, Thailand ICON Full timeAt 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,...
-
Cra Ii
3 weeks ago
กรุงเทพมหานคร, Thailand ICON Full timeAt 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,...
-
Cra Ii
5 days ago
กรุงเทพมหานคร, Thailand ICON plc Full timeAt 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,...
-
Cra Ii
5 days ago
กรุงเทพมหานคร, Thailand ICON Full timeAt 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,...
-
Associate Cra
4 weeks ago
กรุงเทพมหานคร, Thailand MSD Full time**Job Description**: **THE OPPORTUNITY** With support, to acts as primary site contact and site manager throughout all phases of a clinical research study, taking responsibility of allocated sites. **WHAT YOU WILL DO** **Key Responsibilities**: - Develops strong site relationships and ensures continuity of site relationships through all phases of the...
-
Cra Ii or Sr Cra
3 weeks 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...
-
Cra Ii
4 weeks ago
กรุงเทพมหานคร, Thailand ICON plc Full timeAt 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,...
-
Associate Cra
2 weeks ago
กรุงเทพมหานคร, Thailand MSD Full time**THE OPPORTUNITY** With support, to acts as primary site contact and site manager throughout all phases of a clinical research study, taking responsibility of allocated sites. **WHAT YOU WILL DO** **Key Responsibilities**: - Develops strong site relationships and ensures continuity of site relationships through all phases of the trial. - Performs...
-
Sr Cra I
1 week 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...
-
Inhouse Clinical Research Associate
4 weeks ago
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**: -...
-
Associate Clinical Research Associate
4 weeks ago
กรุงเทพมหานคร, Thailand MSD Full timeWith 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...
-
Clinical Research Associate Manager
1 week ago
กรุงเทพมหานคร, Thailand MSD Full time**Job Description**: **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...
-
Clinical Research Associate Manager
3 weeks ago
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,...
-
Associate Clinical Research Associate
3 weeks ago
กรุงเทพมหานคร, Thailand MSD (THAILAND) LTD. Full timeDevelops 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...
-
Clinical Trials Assistant
3 weeks ago
กรุงเทพมหานคร, Thailand IQVIA Full time**Responsibilities**: - Assist Clinical Research Specialist (CRS)/In-house Clinical Research Specialist (iCRS), Clinical Research Associates (CRAs)/In-house Clinical Research Associate (iCRA) and Regulatory and Start-Up (RSU) with accurately updating and maintaining clinical systems that track site compliance and performance within project timelines. -...
-
Senior Clinical Research Associate
3 weeks ago
กรุงเทพมหานคร, Thailand MSD (THAILAND) LTD. Full timeDevelops 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...
-
Senior Clinical Research Associate
4 weeks ago
กรุงเทพมหานคร, Thailand MSD Full timeThe role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA manager or CRD, 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...
