Thermo Fisher Scientific Hiring Clinical Research Associate – Apply Online


Thermo Fisher Scientific Hiring Clinical Research Associate

Job title: Clinical Research Associate (CRA) (Level II)

Job Location: New Delhi, Delhi, India

Education Level: Bachelor’s degree in a life sciences-related field

Job Category: Clinical Research

Job Type: Full Time.

Company Overview:

PPD is a global organization with a talented, bright, and energetic team. The Clinical department consists of experienced colleagues with therapeutic knowledge and operational tools. PPD helps clients define and develop clinical programs, minimize delays, and execute high-quality, cost-efficient clinical studies.

Job Summary (Summarized Purpose):

– Perform and coordinate all aspects of the clinical monitoring and site management process.

– Ensure protocol and regulatory compliance, manage documentation, and follow sponsor guidelines.

– Act as a site processes specialist, ensuring adherence to approved protocols, guidelines, regulations, and SOPs.

– Ensure subject rights, well-being, and data reliability, while maintaining audit readiness.

Essential Functions:

  1. Risk-Based Monitoring and Site Management:

   – Conduct remote or on-site visits to assess compliance and manage documentation.

   – Identify site processes failure and implement corrective/preventive actions.

   – Ensure data accuracy through monitoring activities.

   – Document observations in reports and letters.

   – Escalate deficiencies and issues to clinical management and follow through to resolution.

   – Maintain regular contact with investigative sites.

   – Participate in the investigator payment process.

  1. Investigator Meetings and Site Initiation:

   – Participate in investigator meetings.

   – Identify potential investigators and ensure site acceptability.

   – Initiate clinical trial sites and ensure compliance with protocols and obligations.

   – Perform trial closeout and retrieval of trial materials.

  1. Essential Document Management:

   – Ensure required essential documents are complete and in place.

   – Conduct on-site file reviews.

   – Adhere to ICH-GCP and regulatory requirements.

  1. Trial Tracking and Communication:

   – Provide trial status tracking and progress reports.

   – Maintain complete and accurate study systems.

   – Facilitate effective communication between sites, client company, and project team.

   – Respond to requirements, audits, and inspections.

Additional Responsibilities:

– Complete administrative tasks such as expense reports and timesheets.

– Contribute to project publications/tools and share ideas/suggestions with the team.

– Contribute to other project work and initiatives for process improvement.

Education and Experience:

– Bachelor’s degree in a life sciences related field or Registered Nursing certification.

– Minimal clinical monitoring experience (comparable to 2 years) or relevant health sciences field experience.

– Valid driver’s license (where applicable) and ability to travel.

Knowledge, Skills, and Abilities:

– Basic medical/therapeutic area knowledge and understanding of medical terminology.

– Knowledge of ICH GCPs and applicable regulations.

– Good communication, interpersonal, organizational, and time management skills.

– Customer-focused with attention to detail and good problem-solving abilities.

– Critical thinking skills, including root cause analysis.

– Familiarity with Risk-Based Monitoring concepts.

– Ability to work independently and in a team.

– Proficiency in Microsoft Office and ability to learn new software.

– Fluent in English with good language and grammar skills.

Working Environment:

– Able to communicate effectively with diverse groups of people.

– Able to work in non-traditional work environments.

– Proficient in using standard office equipment and technology.

– Able to handle multiple projects under pressure.

– May have exposure to potentially hazardous elements.

– This role requires independent travel up to 80%.

PPD Defining Principles:

– Strong will to win.

– Earn customer trust.

– Gamechangers.

– Do the right thing.



Leave a Comment