[Remote] FSP CRA (Level II) at Thermo Fisher Scientific

China

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Clinical Research, Pharmaceuticals, HealthcareIndustries

Requirements

Applies root cause analysis (RCA), critical thinking and problem-solving skills
Knowledge of protocol compliance, ICH-GCP guidelines, applicable regulations, and SOPs
Ability to conduct remote or on-site visits and manage documentation
Skills in data accuracy verification through SDR, SDV, and CRF review
Proficiency in investigational product inventory and records review
Experience with business writing standards for reports and letters
Capability to escalate deficiencies and follow issues to resolution
Familiarity with risk-based monitoring approach
Ability to maintain regular contact with sites and conduct supervising tasks per monitoring plan
Participation in investigator payment process and shared responsibility for issue resolution
Knowledge of trial initiation, close-out, and material retrieval procedures
Ensures crucial documents are complete per ICH-GCP and regulations
Ability to conduct on-site file reviews
Proficiency in trial status tracking, progress reports, and updating study systems (e.g., CTMS)
Strong communication skills (written, oral, electronic) with sites, clients, and project teams
Responsiveness to audits/inspections and regulatory requirements

Responsibilities

Monitors investigator sites with a risk-based monitoring approach, identifying process failures and corrective/preventive actions
Ensures data accuracy through SDR, SDV, and CRF review via on-site and remote activities
Assesses investigational product through physical inventory and records review
Documents observations in reports and letters timely using approved standards
Escalates deficiencies/issues to clinical management and follows through to resolution
Maintains regular contact with sites between visits to confirm protocol adherence, issue resolution, and timely data recording
Conducts supervising tasks per approved monitoring plan
Participates in investigator payment process
Shares responsibility with project team on issues/findings resolution and investigates/follows up on findings
Participates in investigator meetings
Identifies potential investigators in collaboration with client
Initiates clinical trial sites per procedures, ensuring compliance and making recommendations
Performs trial close-out and retrieval of trial materials
Ensures crucial documents are complete and conducts on-site file reviews per specifications
Provides trial status tracking and progress update reports to CTM
Updates study systems per agreed conventions (e.g., CTMS)
Facilitates communication between sites, client, and PPD project team
Responds to company, client, and regulatory audits/inspections

Skills

Key technologies and capabilities for this role

Clinical MonitoringSite ManagementICH-GCPRisk-Based MonitoringRoot Cause AnalysisRegulatory ComplianceProtocol ComplianceSOPsAudit ReadinessCritical ThinkingProblem-Solving

Questions & Answers

Common questions about this position

What is the work schedule and location for this FSP CRA role?

The position is full-time with a standard Monday-Friday schedule and is based in an office environment.

What are the key responsibilities of this Clinical Research Associate position?

The role involves monitoring investigator sites using a risk-based approach, conducting remote or on-site visits to ensure protocol compliance, managing documentation, and developing collaborative relationships with sites.

What skills are essential for success in this CRA Level II role?

Key skills include root cause analysis, critical thinking, problem-solving, risk-based monitoring, and ensuring compliance with ICH-GCP guidelines, regulations, and SOPs.

What is the company culture like at Thermo Fisher Scientific?

The company emphasizes meaningful work with global impact, providing resources for career goals, and fostering collaborative teams focused on advancing science through research and delivery of life-changing therapies.

What makes a strong candidate for this FSP CRA position?

Strong candidates demonstrate determination to deliver quality and accuracy, expertise in clinical monitoring and site management, and the ability to build collaborative relationships with investigational sites while ensuring audit readiness and compliance.

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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