Not SpecifiedCompensation
Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
Biotechnology, Pharmaceuticals, Clinical ResearchIndustries

Job Description: Clinical Research Associate

Employment Type: Full-time Work Schedule: Standard (Mon-Fri) Location Type: Office Environmental Conditions: Office

Position Overview

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Summarized Purpose

Performs and coordinates different aspects of the clinical monitoring and site management process. Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. Manages procedures and guidelines from different sponsors and/or supervising environments (i.e. FSO, FSP, Government, etc.). Acts as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects' rights, well-being, and data reliability. Ensures audit readiness. Develops collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to the role are outlined in the task matrix.

Key Responsibilities

  • Site Monitoring: Monitors investigator sites with a risk-based monitoring approach, applying root cause analysis (RCA), critical thinking, and problem-solving skills to identify site process failures and implement corrective/preventive actions to bring the site into compliance and decrease risks.
  • Data Accuracy: Ensures data accuracy through Source Data Review (SDR), Source Data Verification (SDV), and Case Report Form (CRF) review as applicable through on-site and remote monitoring activities.
  • Investigational Product Assessment: Assesses investigational product through physical inventory and records review.
  • Documentation & Reporting: Documents observations in reports and letters in a timely manner using approved business writing standards.
  • Issue Escalation & Resolution: Escalates observed deficiencies and issues to clinical management expeditiously and follows all issues through to resolution.
  • Site Communication: May need to maintain regular contact between monitoring visits with investigative sites to confirm protocol adherence, resolution of previously identified issues, and timely data recording.
  • Supervision & Payments: Conducts supervising tasks in accordance with the approved monitoring plan. Participates in the investigator payment process.
  • Team Collaboration: Ensures shared responsibility with other project team members on issues/findings resolution. Investigates and follows up on findings as applicable.
  • Investigator Meetings: Participates in investigator meetings as vital.
  • Investigator Identification: Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites.
  • Site Initiation: Initiates clinical trial sites according to relevant procedures to ensure compliance with protocol and regulatory and ICH GCP obligations, making recommendations where warranted.
  • Trial Close-out: Performs trial close-out and retrieval of trial materials.
  • Essential Document Management: Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.
  • Reporting & Updates: Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required.
  • System Updates: Ensures study systems are updated per agreed study conventions (e.g., Clinical Trial Management System).
  • Communication Facilitation: Facilitates effective communication between investigative sites, the client company, and the PPD project team through written, oral, and/or electronic contacts.
  • Regulatory Compliance: Responds to company, client, and applicable regulatory requirements/audits.

Application Instructions

  • (No specific application instructions were provided in the original text.)

Company Information

Thermo Fisher Scientific is dedicated to enabling their customers to make the world healthier, cleaner, and safer. They provide resources for individual career goals and advance science through research, development, and delivery of life-changing therapies. Their PPD clinical research portfolio includes clinical trials in over 100 countries and the development of novel frameworks for clinical research, encompassing laboratory, digital, and decentralized clinical trial services.

Skills

Clinical Monitoring
Site Management
Protocol Compliance
Regulatory Compliance
ICH-GCP
Risk-Based Monitoring
Root Cause Analysis
Critical Thinking
Problem-Solving
Corrective and Preventive Actions

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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