[Remote] Senior Clinical Research Associate (CRA) - Client-dedicated at Thermo Fisher Scientific

Poland

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceutical, Biotechnology, Clinical Research, CROIndustries

Requirements

University degree in a science related field
Understanding of ICH-GCP, EU and FDA requirements
Fluency in English
Valid driver’s license
Proven clinical monitoring skills
Experience from working on Cell & Gene Therapy studies
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 but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving
Ability to manage

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
Assess 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. May need to maintain 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. 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

Key technologies and capabilities for this role

Risk-Based MonitoringRoot Cause AnalysisCritical ThinkingSource Data ReviewSource Data VerificationCRF ReviewOn-Site MonitoringRemote MonitoringInvestigational Product InventoryProtocol ComplianceClinical Site Management

Questions & Answers

Common questions about this position

Is this a full-time position?

Yes, this is a full-time position.

What is the work schedule and location for this role?

The work schedule is standard Monday-Friday in office environmental conditions, involving both on-site and remote monitoring activities.

What are the key skills required for this Senior CRA role?

Key skills include risk-based monitoring, root cause analysis, critical thinking, problem-solving, data accuracy review through SDR/SDV/CRF, and knowledge of ICH GCP regulations.

What is the company culture like at PPD, part of Thermo Fisher Scientific?

The culture emphasizes meaningful work with global impact, enabling customers to make the world healthier through research, development, and delivery of life-changing therapies, while providing resources for individual career goals.

What experience makes a strong candidate for this CRA position?

Strong candidates are CRAs currently working in the life science sector for pharmaceutical companies, biotech companies, or CROs, with skills in site monitoring, compliance, and issue resolution.

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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