Clinical Research Associate

2 months ago

Pretoria, Gauteng, South Africa Thermo Fisher Scientific Full time
Job Summary

We are seeking a highly skilled Clinical Research Associate (CRA) - Level II to join our team at Thermo Fisher Scientific. As a CRA, you will be responsible for monitoring investigator sites with a risk-based approach, ensuring data accuracy, and conducting on-site file reviews. If you have a strong background in clinical research, excellent communication skills, and a passion for regulatory compliance, we encourage you to apply.

Key Responsibilities
  • Monitor investigator sites with a risk-based approach, applying root cause analysis and problem-solving skills to identify site processes failures and corrective/preventive actions.
  • Ensure data accuracy through SDR, SDV, and CRF review, as applicable, through on-site and remote monitoring activities.
  • Assess investigational products through physical inventory and records review.
  • Document observations in reports and letters using approved business writing standards.
  • Raise observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution.
  • Conduct on-site file reviews as per project specifications.
  • Provide trial status tracking and progress update reports to the team as required.
  • Ensure study systems are complete, accurate, and updated per agreed study conventions (Clinical Trial Management System).
  • Facilitate effective communication between investigative sites, client company, and internal project teams through written, oral, and/or electronic contacts.
  • Respond to company, client, and applicable regulatory requirements/audits/inspections.
Requirements
  • Bachelor's degree in a life sciences field.
  • Clinical monitoring experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 2-3 years) in a clinical environment where experience is gained in clinical trials, medical terminology, medical research, clinical research, or health care.
  • Valid driver's license where applicable.
  • Ability to attain and maintain a proven understanding of ICH GCPs and industry regulations and procedural documents.
  • Good oral and written communication skills, with ability to communicate effectively with medical personnel.
  • Good interpersonal skills.
  • Ability to maintain customer focus through the utilization of good listening skills, attention to detail, and the ability to perceive customers' underlying issues.
  • Good organizational and time management skills.
  • Ability to remain flexible and adaptable in a wide range of scenarios.
  • Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem-solving.
  • Ability to manage Risk-Based Monitoring concepts and processes.
  • Ability to work in a team or independently as required.
  • Good digital literacy: proven knowledge of Microsoft Office and ability to learn appropriate software.
  • Good English language and grammar skills.
  • Flexibility to travel in-country and to other countries within Africa.
What We Offer

As a Clinical Research Associate (CRA) - Level II at Thermo Fisher Scientific, you will benefit from a competitive salary, an extensive benefits package based around the health and well-being of our employees, and a collaborative environment with teams of colleagues eager to share expertise and have fun together. We value a work-life balance and offer opportunities for professional growth and development. Join our team and contribute to accelerating research, solving complex scientific challenges, and supporting patients in need.

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