[Remote] Senior Clinical Research Associate - Central and West Coast (Cell & Gene Therapy) at Thermo Fisher Scientific

California, United States

Apply Now

Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Pharmaceuticals, Clinical ResearchIndustries

Requirements

Experienced CRA (Level II, Sr CRA Level I/II, or Principal CRA)
Ability to perform remote and on-site visits
Knowledge of risk-based monitoring, root cause analysis (RCA), critical thinking, and problem-solving
Familiarity with protocol compliance, regulatory requirements, ICH GCP, and applicable regulations
Proficiency in data review processes (SDR, SDV, CRF)
Skills in business writing standards for reports and letters
Capability to assess investigational products via inventory and records review
Experience with clinical trial initiation, close-out, and site management
Ability to facilitate communication (written, oral, electronic) between sites, clients, and project teams
Responsiveness to audits/inspections and regulatory requirements

Responsibilities

Monitor investigator sites using a risk-based approach, applying RCA to identify and resolve site process failures
Ensure data accuracy through SDR, SDV, and CRF review during on-site and remote monitoring
Assess investigational products through physical inventory and records review, documenting observations timely
Escalate deficiencies/issues to clinical management and follow through to resolution
Maintain regular contact with sites between visits to confirm protocol adherence, issue resolution, and timely data recording
Conduct monitoring tasks per the approved monitoring plan and participate in investigator payment process
Share responsibility with project team for issues/findings resolution and follow-up
Participate in investigator meetings and identify potential investigators with clients
Initiate clinical trial sites per procedures, ensuring protocol, regulatory, and ICH GCP compliance
Perform trial close-out and retrieval of trial materials
Ensure essential documents are complete per ICH-GCP and regulations; conduct on-site file reviews
Provide trial status tracking and progress updates to Clinical Team Manager (CTM)
Update study systems (e.g., Clinical Trial Management System) per conventions
Facilitate communication between sites, clients, and PPD project team
Respond to company, client, and regulatory audits/inspections

Skills

Key technologies and capabilities for this role

Clinical MonitoringSite ManagementRisk-Based MonitoringRoot Cause AnalysisRegulatory ComplianceProtocol ComplianceClinical TrialsData AccuracyProblem-SolvingCell & Gene Therapy

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