[Remote] FSP CRA 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

Applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions
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
Competence in business writing standards for reports and letters
Ability to escalate deficiencies and follow issues to resolution
Experience with supervising tasks per monitoring plan
Familiarity with Clinical Trial Management System (CTMS) and study systems updates
Participation in investigator meetings and site identification/selection

Responsibilities

Monitors investigator sites with a risk-based monitoring approach, ensuring compliance and decreasing risks
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 and issues to clinical management and follows through to resolution
Maintains regular contact with sites between visits to verify 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
Provides trial status tracking and progress update reports to Clinical Team Manager (CTM)
Ensures study systems (e.g., CTMS) are updated per conventions and performs QC checks on reports
Participates in investigator meetings and identifies potential investigators with client
Initiates clinical trial sites per procedures, ensuring protocol, regulatory and ICH-GCP compliance
Ensures trial close-out and retrieval of trial materials
Verifies crucial documents are complete per ICH-GCP and regulations; conducts on-site file reviews
Contributes to project team by assisting in publications/tools preparation and sharing ideas
Performs additional study tasks as assigned by CTM

Skills

Clinical Monitoring

Site Management

ICH-GCP

Risk-Based Monitoring

Root Cause Analysis

SDV

SDR

Protocol Compliance

Regulatory Compliance

Audit Readiness

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