FSP Clinical Research Associate I/II - Oncology (Quebec - bilingual) at Thermo Fisher Scientific

Canada

Thermo Fisher Scientific Logo
Not SpecifiedCompensation
Junior (1 to 2 years), Mid-level (3 to 4 years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceuticals, Biotechnology, HealthcareIndustries

Requirements

Candidates must have a Bachelor's degree in a related field or equivalent experience, with a strong preference for oncology experience and bilingual proficiency in French and English, particularly for candidates located in Quebec. A minimum of 6 months to 1 year of direct onsite monitoring experience is highly preferred. Proven ability to monitor investigator sites, assess investigational product compliance, and demonstrate outstanding critical thinking and problem-solving skills are essential. Proficiency in ICH-GCP and regulatory standards, along with excellent communication and organizational skills, is required. The ability to work collaboratively within a team is also necessary.

Responsibilities

The Clinical Research Associate will monitor investigator sites, analyze root causes of issues, and implement solutions to improve compliance and minimize risks. Responsibilities include assessing investigational products, ensuring data accuracy through various review methods, and promptly reporting and resolving observed deficiencies. The role involves maintaining continuous contact with investigative sites, conducting monitoring tasks and visits according to the approved plan, and collaborating with project team members. The associate will provide trial status updates, update study systems, participate in investigator meetings, identify potential investigators, and commence/closeout clinical trial sites. Ensuring essential documents are complete, conducting on-site file reviews, contributing to project publications, facilitating communication between sites, the client, and the project team, and completing administrative tasks are also key duties. The role requires addressing company, client, and regulatory needs, audits, and inspections.

Skills

Clinical Research
Oncology
Monitoring
ICH-GCP
Regulatory Requirements
Data Accuracy
French
English

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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