[Remote] FSP CRA (Sponsor: AstraZeneca) at Thermo Fisher Scientific

Igołomia-Wawrzeńczyce, Lesser Poland Voivodeship, Poland

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceutical, Clinical ResearchIndustries

Requirements

University degree in a science related field
At least 5 years of independent monitoring experience in clinical development phases I-III
3 years of Cell & Gene Therapy experience
Understanding of ICH-GCP and KGCP requirements
Fluency in English
Proven clinical monitoring skills
Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
Demonstrated ability to attain and maintain a working knowledge of ICH GCPs, applicable regulations, and procedural documents
Well-developed critical thinking skills, including critical mindset, in-depth investigation for root cause analysis, and problem solving
Ability to manage Risk Based Monitoring concepts and processes
Good oral and written communication skills, with ability to communicate effectively with medical personnel
Ability to maintain customer focus through good listening skills, attention to detail, and perceiving customers’ underlying issues
Good organizational and time management skills
Effective interpersonal skills
Attention to detail
Ability to remain flexible and adaptable in a wide range of scenarios
Ability to work in a team or independently as required
Good computer skills: solid knowledge of Microsoft Office and ability to learn appropriate software

Responsibilities

Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking, and problem-solving skills to identify site process failures 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 protocol adherence, resolution of previously identified issues, and timely data recording
Participates in the investigator payment process
Ensures shared responsibility with other project team members on issues/findings resolution and investigates/follows up on findings as applicable
Participates in investigator meetings as necessary
Identifies potential investigators in collaboration with the client company to ensure acceptability of qualified investigative sites
Initiates clinical trial sites according to relevant procedures to ensure compliance with protocol, regulatory, and ICH GCP obligations, making recommendations where warranted
Performs trial close out and retrieval of trial materials
Ensures 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)

Skills

Key technologies and capabilities for this role

Risk-Based MonitoringRoot Cause AnalysisICH-GCPSDVSDRCRF ReviewSite InitiationSite CloseoutEssential DocumentsInvestigator PaymentsClinical Trial Monitoring

Questions & Answers

Common questions about this position

What education and experience are required for this FSP CRA role?

A university degree in a science-related field is required, along with at least 5 years of independent monitoring experience in clinical development phases I-III and 3 years of Cell & Gene Therapy experience.

What key skills are needed for this position?

Proven clinical monitoring skills, demonstrated understanding of medical/therapeutic area knowledge and medical terminology, well-developed critical thinking skills including root cause analysis and problem solving, and good oral and written communication skills are required.

Is this a remote position or does it require office work?

The role involves on-site and remote monitoring activities at investigator sites, with environmental conditions listed as office, indicating a mix of field and office-based work.

What is the work schedule for this job?

This is a full-time position with a standard Monday-Friday work schedule.

What makes a strong candidate for this CRA role?

Candidates with at least 5 years of independent monitoring experience in phases I-III, 3 years in Cell & Gene Therapy, proven clinical monitoring skills, critical thinking for risk-based monitoring, and fluency in English will stand out.

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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