Clinical Research Associate

This is a 1 year contract home-based in Ha Noi, Vietnam. The type of contract could be extended after CRA performance review.

POSITION PURPOSE:

1. To support project(s) as ICH E6 GCP/applicable local GCP definition of "Monitor"

2. To ensure all designated clinical/ site monitoring activities are conducted in highest quality standards

3. To support project management, clinical monitoring and/or regulatory affairs operations in all aspects of the project(s)

4. To support study start up activities to ensure on-time start up and initiation of the study as possible

5. To assist project team in all project related administrative tasks including status and financial tracking

6. To support project in capacity of "Clinical Trail Assistant (CTA)" as required

7. To provide relevant support and assistance whenever required by the company and project team

RESPONSIBILITIES:

• Responsible for preparing, organizing, managing and monitoring clinical trials in accordance with the highest standards
• Responsible for performing all monitoring aspects of clinical trials as stated in ICH E6 GCP/applicable local GCP to assure all trials are conducted in strict adherence to good clinical practices, regulatory obligations, investigator integrity and compliance with project specific requirements
• Perform site selection, initiation, monitoring and close-out visits in accordance with sponsor's and/or company's standard operating procedures (SOPs) and study requirements
• Develop, compile and/or review all study-related regulatory and administrative documents from investigational sites, monitoring visit reports, work progression reports and other study-required documents
• Develop, compile and/or submit dossiers to regulatory and/or ethics committee for review and follow up until approval, if required
• Support in safety reporting to regulatory and/or ethics committee as required
• Support in planning, coordinating, organizing and attending all study-related meetings and activities for site as required
• Support/assist in feasibility studies, site and investigator identification as required
• Manage/support project in the capacity of Clinical Research Associate, Clinical Trial Assistant and/or designated project roles to undertake all or partial responsibilities and tasks as required, whenever designated by the company
• Support/assist in Site and CRO audit or inspection as required
• Assist to set up, review and maintain project files to ensure compliance to ICH E6 GCP/applicable local GCP, applicable local regulatory and project requirements
• Support Company's operations by assisting/coordinating and conducting orientation and applicable training for new employees as required
• Review, revise and/or develop Clinical Monitoring related SOPs, work guides etc.

REQUIREMENTS:

Qualifications

• Minimum bachelor degree (major in nursing, pharmacy or other biomedical-related background) from a recognized institution, and/or equivalent combination of training and experience
• Certificate in basic GCP courses
• Certificate in monitoring or equivalent training

Experience and Skills

• Minimum 2 year relevant experience in clinical research in healthcare, pharmaceutical and/or CRO industry or 1 year direct experience as monitor in clinical studies
• Preferably has experience in clinical study monitoring
• Good knowledge of ICH/GCP guidelines, SOPs and other applicable regulations
• Strong interpersonal, problem-solving, organization and time management skills
• Ability to produce meticulous and accurate work under pressure and stringent timelines
• Able to work independently and willingness to travel
• Strong computer/technology skills including MS Word, MS Excel and PowerPoint
• Good written and verbal communication skills
• Self-initiative to perform duties
• Meticulous and able to work in a fast-paced environment
• Good team-player
• Ability to multi-task and follow through with assigned tasks
• Good knowledge of ICH/GCP guidelines, SOPs and other applicable regulations

LOCATION:
 Home-based in Ha Noi, Vietnam