Experienced Clinical Research Associate (CRA II, Sr CRA, Principal CRA) - Central and West Coast (Renal, Transplant and/or Nephrology) at Thermo Fisher Scientific

California, United States

Thermo Fisher Scientific Logo
Not SpecifiedCompensation
Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceuticals, Biotechnology, Clinical ResearchIndustries

Requirements

Candidates must be experienced Clinical Research Associates (CRA II, Sr CRA, Principal CRA) with expertise in Renal, Transplant, and/or Nephrology. The role requires the ability to perform and coordinate all aspects of clinical monitoring and site management, including remote and on-site visits. Proficiency in risk-based monitoring, root cause analysis, critical thinking, and problem-solving is essential. Experience with data accuracy checks (SDR, SDV, CRF review), investigational product assessment, and timely documentation of observations is necessary. The role also requires maintaining communication with investigative sites, clients, and project teams, and ensuring compliance with ICH-GCP and applicable regulations. Familiarity with clinical trial management systems and participation in investigator meetings and payment processes are also required.

Responsibilities

The Clinical Research Associate will perform and coordinate clinical monitoring and site management, including remote and on-site visits, to assess protocol and regulatory compliance. They will ensure data accuracy through various review processes and assess investigational products. Responsibilities include documenting observations, escalating deficiencies, maintaining contact with investigative sites, and conducting monitoring tasks according to the approved plan. The CRA will also participate in the investigator payment process, collaborate on issue resolution, and identify potential investigators. They will initiate clinical trial sites, perform trial close-out activities, and ensure essential documents are complete and compliant with regulations. The role involves tracking study progress, updating study systems, and facilitating communication between sites, clients, and the project team, while also responding to regulatory requirements and audits.

Skills

Clinical Monitoring
Site Management
Protocol Compliance
Regulatory Compliance
Risk-Based Monitoring
Root Cause Analysis
Critical Thinking
Problem-Solving
Data Accuracy
Clinical Trials
Nephrology
Renal
Transplant

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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