Assistant CRA

Thermo Fisher Scientific (Thailand) (Bangkok, Bangkok City, Thailand)

Bangkok, Thailand

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.

Detail posisi

As an Assistant CRA (ACRA) at Thermo Fisher Scientific, you will play a crucial role in supporting clinical trials by combining knowledge and expertise to help clients deliver life-changing therapies to market. You will take ownership of tasks, anticipate problems, and deliver results while working collaboratively with a global team.

Kewajiban

• Performs remote activities on assigned projects in liaison with the Remote CRA, On-Site CRA and study CTM.
• Provides support with regards to site preparedness, logistical support to the monitoring process, and assist with assigned tasks for site management and remote monitoring in accordance with SOPs and regulatory guidelines.
• May be assigned limited site contact activities during study start-up, site management, recruitment and close out phases.
• Completes study and site management activities as defined in task matrix, and as applicable and directed for study assigned.
• Completes and documents study-specific training.
• Orients and trains on any company/study-specific systems.
• Provides in-house support during pre-study assessments and with pre-study assessment waivers, as agreed for project.
• Supports to customize Site ICF with site contact details, as needed.
• Performs remote review of EMR/EHR checklist and supports collection, as applicable assessments.
• Verifies document collection and RCR submission status; updates site EDL and verifies site information.
• Reviews patient facing materials and review translations, as directed.
• Supports site staff with the vendor related qualification process, where applicable.
• Provides support by ensuring system access is requested/granted and revoked.

Kualifikasi

• Knowledge of clinical research processes and regulations.
• Strong organizational and communication skills.
• Ability to work independently and as part of a team.
• Proficiency in using clinical trial management systems and other relevant software.
• Attention to detail and commitment to quality.
• Ability to manage multiple tasks and prioritize effectively.