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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:
- 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.
- 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.
- Essential Document Management:
– Ensure required essential documents are complete and in place.
– Conduct on-site file reviews.
– Adhere to ICH-GCP and regulatory requirements.
- 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.
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