Assistant CRA at Thermo Fisher Scientific

Adelaide, South Australia, Australia

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Not SpecifiedCompensation

Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

Clinical Research, Pharmaceuticals, Life SciencesIndustries

Requirements

Ability to perform remote activities on assigned projects in coordination with the internal study team
Knowledge of SOPs and regulatory guidelines for site management and remote monitoring
Capability to complete study-specific training and orient/train on CRG/study-specific systems
Skills in providing in-house support during pre-study assessments
Proficiency in remote review of EMR/EHR checklists and supporting collection/assessments
Ability to verify document collection, RCR submission status, update site EDL, and verify site information
Competence in reviewing patient-facing materials and translations
Experience supporting site staff with vendor qualification processes
Ability to ensure system access is requested, granted, or revoked for site staff and oversee site staff training
Skills in coordinating logistics for IM attendance and maintaining vendor trackers
Capability to coordinate study/site supply management
Proficiency in supporting essential document collection, review, and updating in systems
Ability to resolve missing vendor data (e.g., ECGs, lab samples, e-diaries)
Competence in conducting ongoing remote review of centralized monitoring tools
Skills in facilitating site payment processes and coordinating with functional departments
Ability to support system updates, reconciliations, and follow-up on site invoices
Proficiency in performing reconciliation tasks (e.g., CRF/query status, deviations, SAEs, safety reports)
Capability to verify document collection status in CRG systems and drive actions for missing/incomplete/expired documents
Ability to maintain and complete administrative tasks (e.g., training, expense reports, timesheets) in a timely manner
Works on problems of limited scope and follows standard practices and procedures

Responsibilities

Completes study and site management activities as defined in task matrix and as directed for assigned studies
Completes and documents study-specific training
Orients and trains on CRG/study-specific systems
Provides in-house support during pre-study assessments
Performs remote review of EMR/EHR checklist and supports collection/assessments as applicable
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 the vendor qualification process
Ensures system access is requested, granted, or revoked for relevant site staff throughout the study; oversees site staff training and ensures it is current
Coordinates and supports logistics for IM attendance as directed
Supports maintenance of vendor trackers as directed
Coordinates study/site supply management during pre-activation and subsequent course of the study
Supports essential document collection, review, and updating in systems as applicable
Resolves missing vendor data such as ECGs, lab samples, and e-diaries as directed
Conducts ongoing remote review of centralized monitoring tools as directed
Facilitates site payment processes by coordinating with various functional departments and the site
Supports system updates and reconciliations and follows up on site invoices throughout the study period
Performs reconciliation tasks on assigned trials including CRF/query status, deviations, SAEs, and safety reports as applicable
Verifies document collection status in CRG systems and drives action for missing/incomplete/expired documents and open document findings as directed
Performs other assigned site management tasks as directed by study team and per Task Matrix
Performs specific role profile for FSP opportunities according to client requests
Maintains and completes administrative tasks such as training, expense reports, and timesheets in a timely manner

Skills

Key technologies and capabilities for this role

Clinical ResearchSite ManagementStudy Start-upRemote MonitoringRegulatory ComplianceSOPsRecruitmentStudy Close-outSite ContactTraining

Questions & Answers

Common questions about this position

Is this a remote position?

Yes, the Assistant CRA performs remote activities on assigned projects in coordination with the internal study team.

What is the salary for the Assistant CRA role?

This information is not specified in the job description.

What are the main responsibilities of the Assistant CRA?

The role involves completing study and site management activities, remote review of EMR/EHR checklists, verifying document collection, supporting site staff training, and coordinating study supply management.

What is the work schedule for this position?

The work schedule is standard Monday through Friday in an office environment.

What kind of company culture does Thermo Fisher Scientific offer?

The company emphasizes meaningful work with positive global impact, providing resources for individual career goals and enabling science to advance through research and delivery of life-changing therapies.

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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