Assistant CRA at Thermo Fisher Scientific

Taipei, Taiwan

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Not SpecifiedCompensation

Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

Clinical Research, Pharmaceuticals, HealthcareIndustries

Requirements

Ability to perform remote activities in liaison with CRA and study Clinical Lead
Knowledge of SOPs and regulatory guidelines for site management and remote monitoring
Capability to complete study-specific training and orient/train on study-specific systems
Proficiency in administrative tasks such as expense reports and timesheets
Flexibility for working modes: Office, Flex, or Remote

Responsibilities

Completes study and site management activities as defined in task matrix and as directed
Completes and documents study-specific training
Orients and trains on study-specific systems
Provides in-house support during pre-study assessments and with pre-study assessment waivers
Supports customization of Site ICF with site contact details
Performs remote review of EMR/EHR checklist and supports collection
Verifies document collection and RCR submission status; updates site EDL and verifies site information
Reviews patient-facing materials and translations, as directed
Supports site staff with vendor-related qualification process
Ensures system access is requested/granted and revoked for site staff
Follows up on site staff training
Coordinates logistics for IM attendance
Supports maintenance of vendor trackers
Coordinates study/site supply management
Supports essential document collection, review, and updating
Follows up on missing study vendor data (e.g., ECGs, lab samples, e-diaries)
Supports ongoing remote review of centralized monitoring tools
Supports site payments processes, system updates, reconciliations, and site invoices
Performs reconciliation tasks (e.g., CRF/query status, deviations, SAEs, safety reports)
Verifies document collection status and drives action for missing/incomplete/expired documents
Performs other assigned site management tasks as directed by CRA and per Task Matrix
Performs specific role profiles for FSP opportunities per client requests
Maintains and completes administrative tasks like expense reports and timesheets timely
May perform limited site contact activities during study start-up, management, recruitment, and close-out phases

Skills

Key technologies and capabilities for this role

CRA supportsite managementremote monitoringSOP complianceregulatory guidelinesstudy start-upEDL managementICF customizationEMR/EHR reviewvendor qualificationsystem access managementessential document collectionpatient facing materials review

Questions & Answers

Common questions about this position

Is this position remote or office-based?

The working mode can be Office, Flex, or Remote.

What are the essential functions of this Assistant CRA role?

Essential functions include completing study and site management activities as defined in the task matrix, providing support for site preparedness and monitoring, managing essential documents, supporting site payments, and performing reconciliation tasks on assigned trials.

What is the salary for the Assistant CRA position?

This information is not specified in the job description.

What are the benefits offered for this role?

This information is not specified in the job description.

What makes a strong candidate for this Assistant CRA position?

Strong candidates should have experience or ability to handle clinical study tasks like site management, document collection, remote monitoring support, and administrative duties such as timesheets and expense reports, while following SOPs and regulatory guidelines.

Thermo Fisher Scientific

Provides life sciences products and services

About Thermo Fisher Scientific

Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.

Waltham, MassachusettsHeadquarters

1956Year Founded

$17MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Increased competition in single-use bioprocessing may impact market share.

Sale of anatomical pathology business could create a temporary product gap.

Investment in miDiagnostics may face regulatory challenges affecting returns.

Differentiation

Thermo Fisher offers a comprehensive range of life sciences products and services.

Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.

They provide strong customer support and educational resources to optimize client workflows.

Upsides

Expansion of biologics production facility enhances capacity for precision biologics monitoring.

Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.

Collaboration with Mainz Biomed positions them in the growing cancer detection market.

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