[Remote] Senior Clinical Research Associate at Thermo Fisher Scientific

Romania

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Clinical Research, Pharmaceuticals, BiotechnologyIndustries

Requirements

Bachelor's degree in a life science related field or equivalent

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 in a timely manner using approved business writing standards
Brings 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
Conducts monitoring tasks in accordance with the approved monitoring plan
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 and may help to identify 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 team as required
Ensures study systems are complete, accurate and updated per agreed study conventions (e.g. Clinical Trial Management System)
Facilitates effective communication between investigative sites, the client company and internal project teams through written, oral and/or electronic contacts
Responds to company, client and applicable regulatory requirements/audits/inspections
Maintains and completes administrative tasks such as expense reports and timesheets in a timely manner

Skills

Key technologies and capabilities for this role

Clinical MonitoringSite ManagementICH-GCPRisk-Based MonitoringRoot Cause AnalysisSDVSDRCRF ReviewProtocol ComplianceRegulatory ComplianceAudit Readiness

Questions & Answers

Common questions about this position

Is this a remote position or does it require on-site work?

The role involves conducting remote or on-site visits to investigator sites for monitoring and site management.

What are the key responsibilities of a Senior Clinical Research Associate?

Key responsibilities include monitoring investigator sites with a risk-based approach, ensuring data accuracy through reviews, assessing investigational product inventory, documenting observations, and maintaining site contact between visits.

What skills are essential for this CRA role?

Essential skills include root cause analysis, critical thinking, problem-solving, risk-based monitoring, and knowledge of ICH-GCP guidelines, regulations, and SOPs.

What is the work schedule and employment type for this position?

This is a full-time position with a standard Monday-Friday work schedule in an office environment.

What makes a strong candidate for the Senior CRA role at Thermo Fisher Scientific?

A strong candidate demonstrates determination to deliver quality and accuracy, excels in clinical monitoring, site management, risk-based approaches, and ensuring compliance with protocols, ICH-GCP, and regulations.

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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