[Remote] CRA II FSP at Thermo Fisher Scientific

Italy

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Clinical Research, Pharmaceutical, Biotechnology, CROIndustries

Requirements

University degree in a science related field
CRA Qualified as per the Ministerial Decree dated 15/11/2011
At least 1 year of independent monitoring experience in clinical development phases II-IV
Understanding of ICH-GCP, EU and FDA requirements
Fluency in English and in Italian
Valid Driver's License
Proven clinical monitoring skills
Demonstrated understanding of medical (incomplete in description)

Responsibilities

Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks
Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities
Assesses investigational product through physical inventory and records review
Documents observations in reports and letters according to timelines using approved business writing standards
Escalates observed deficiencies and issues to clinical management expeditiously and follows all issues through to resolution
Maintains regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner
Participates in the investigator payment process
Ensures a shared responsibility with other project team members on issues/findings resolution and investigates and follows-up on findings as applicable
Participates in investigator meetings as necessary
Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites
Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted
Performs trial close out and retrieval of trial materials
Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations
Conducts on-site file reviews as per project specifications
Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required
Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System)
Contributes to the project team by assisting in preparation of project publications/tools and sharing ideas/suggestions with team members
Contributes to other project work and initiatives for process improvement, as required

Skills

Risk-Based Monitoring

Root Cause Analysis

Critical Thinking

Problem-Solving

Source Data Review

Source Data Verification

CRF Review

On-Site Monitoring

Remote Monitoring

Investigational Product Inventory

Clinical Trial Monitoring

Business Writing

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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