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

China

Apply Now

Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Clinical Research, Pharmaceuticals, HealthcareIndustries

Requirements

Knowledge of protocol compliance, ICH-GCP guidelines, applicable regulations, and SOPs
Ability to apply root cause analysis (RCA), critical thinking, and problem-solving skills
Skills in data review (SDR, SDV, CRF) and investigational product inventory
Proficiency in documentation using approved business writing standards
Capability to escalate issues and follow through to resolution
Experience with supervising tasks per monitoring plans
Familiarity with clinical trial initiation, close-out, and file reviews
Ability to update study systems (e.g., Clinical Trial Management System)
Strong communication skills (written, oral, electronic)
Preparedness for audits, inspections, and regulatory requirements

Responsibilities

Monitors investigator sites using a risk-based 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 and issue resolution
Conducts supervising tasks per the approved monitoring plan
Participates in the investigator payment process
Shares responsibility with project team on issues/findings resolution and investigates/follows up as applicable
Participates in investigator meetings as vital
Identifies potential investigators in collaboration with the 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 per ICH-GCP and regulations
Conducts on-site file reviews per project specifications
Provides trial status tracking and progress updates to the Clinical Team Manager (CTM)
Updates study systems per agreed conventions
Facilitates communication between sites, client, and project team
Responds to company, client, and regulatory audits/inspections

Skills

Clinical Monitoring

Site Management

ICH-GCP

Risk-Based Monitoring

Root Cause Analysis

Regulatory Compliance

Protocol Compliance

SOPs

Audit Readiness

Critical Thinking

Problem-Solving

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.

Land your dream remote job 3x faster with AI

Try Jobo Free