Not SpecifiedCompensation
Mid-level (3 to 4 years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceuticals, HealthcareIndustries

Requirements

Candidates must possess a Bachelor's degree in a life sciences field or a Registered Nursing certification, equivalent to 2+ years of experience as a clinical research monitor. A valid driver's license is also required.

Responsibilities

The Sr CRA I will monitor investigator sites using a risk-based approach, performing root cause analysis and implementing corrective actions to ensure compliance and reduce risks. Responsibilities include ensuring data accuracy through reviews, assessing investigational products, documenting observations in reports, escalating deficiencies, and maintaining communication with investigative sites. The role involves conducting monitoring tasks according to the plan, participating in investigator payments, updating study systems, and potentially participating in investigator meetings. Additionally, the Sr CRA I will identify potential investigators, initiate clinical trial sites, ensure trial close-out and document completion, and contribute to project team efforts. Facilitating communication between sites, clients, and the project team, responding to regulatory requirements, and completing administrative tasks are also key duties.

Skills

risk-based monitoring
root cause analysis
RCA
critical thinking
problem-solving
SDR
SDV
CRF review
on-site monitoring
remote monitoring
investigator sites
data accuracy
physical inventory
records review
business writing
monitoring plan
investigator payment process
issue resolution
team collaboration

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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