Not SpecifiedCompensation
Entry Level & New Grad, Junior (1 to 2 years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceuticals, Biotechnology, Clinical Research ServicesIndustries

Requirements

The Assistant CRA role requires a full-time commitment with a standard Monday-Friday work schedule. While specific educational qualifications are not detailed, the role involves performing remote activities in liaison with CRAs and study teams, supporting site preparedness, and assisting with site management and remote monitoring tasks in accordance with SOPs and regulatory guidelines. Limited site contact activities may be assigned during various study phases.

Responsibilities

The Assistant CRA will complete study and site management activities as defined in the task matrix, including study-specific training and orientation on CRG/study-specific systems. Responsibilities include providing in-house support for pre-study assessments, customizing Informed Consent Forms, performing remote review of EMR/EHR checklists, verifying document collection and RCR submission status, and reviewing patient-facing materials and translations. The role also involves supporting site staff with vendor qualification processes, ensuring system access for site staff, following up on site staff training, coordinating logistics for Investigator Meeting attendance, and maintaining vendor trackers. Additionally, the Assistant CRA will support study/site supply management, assist with essential document collection and review, follow up on missing study vendor data, support ongoing remote review of centralized monitoring tools, and assist with site payment processes and system updates. Reconciliation tasks for assigned trials, including CRF and query status, deviations, and SAEs, are also part of the role, along with verifying document collection status and driving action for missing documents. The Assistant CRA may also perform other assigned site management tasks and specific role profiles for FSP opportunities.

Skills

Clinical Research
Site Management
Remote Monitoring
SOPs
Regulatory Guidelines
Study Start-up
Study Close Out
Data Management

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.

Land your dream remote job 3x faster with AI