[Remote] Assistant CRA at Thermo Fisher Scientific

Germany

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Not SpecifiedCompensation

Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Pharmaceuticals, BiotechnologyIndustries

Requirements

Knowledge of FDA and/or local regulations and guidelines, ICH GCPs, and company procedural documents
Ability to perform remote site management and monitoring activities
Skills in reviewing study data from various sources remotely
Capability to contact study sites to collect documentation, resolve issues, and request information
Experience with EDC systems for tracking, querying, and data management
Proficiency in risk-based monitoring, root cause analysis (RCA), critical thinking, and problem-solving
Ability to evaluate PI oversight, subject safety, and study processes
Skills in conducting remote investigations and implementing corrective/preventive actions
Competence in providing refresher training and assisting with administrative and regulatory needs
Familiarity with clinical listings review, tracking violations/deviations, enrollment, CRF status, and SAE follow-up

Responsibilities

Develop and maintain close, collaborative communication with site staff, discussing protocol conduction, enrollment strategies, issues, EDC completion, queries, and project status
Complete/track/follow up ETRTR for subject data in EDC and other systems per study guidelines; raise manual queries as applicable
Remotely review study logs as necessary
Conduct and document site management calls/contacts according to the monitoring plan; participate in investigator meetings
Investigate and follow up on centralized monitoring findings
Evaluate PI oversight (e.g., protocol adherence), subject safety, and study processes to assess site performance regularly
Conduct remote investigations into site performance using risk-based monitoring, RCA, critical thinking, and problem-solving to identify failures and implement corrective/preventive actions
Provide refresher training, follow up on outstanding administrative needs (e.g., regulatory documents), assist with regulatory reviews as requested
Review ad-hoc clinical listings, track and trend violations/deviations, site status, enrollment, CRF status, and SAE follow-up
Provide trial status tracking and progress update reports to the study manager
Participate in investigator payments (incomplete in description)

Skills

Clinical Research

Clinical Trials

CRA

Decentralized Trials

Regulatory Compliance

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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