CRA - Freelance Consultants - Based in Malaysia and Thailand
Pharmalancers LtdMalaysia19 days ago
Company Description
Pharmalancers is The Global Marketplace connecting independent consultants in Clinical research to relevant projects in the pharmaceutical, biotechnology, and life sciences industry. We currently are looking for experienced independent CRAs to join a global team in the conduct of a study in rare disease.
Role Description
This is a contract remote role for fractional / freelance CRAs based in Malaysia and Thailand. The Consultants need to be well-versed in clinical trial management. They are rigorous, detail-oriented, and precise in their analysis reports.
You will be required to manage the data collected during trials, oversee trial sites, and conduct regular site visits to monitor the progress. You will also collaborate with the sponsors at trial sites and ensure the tests are conducted ethically while adhering to applicable regulations and guidelines by:-
• Ensuring compliance with protocols, standard operating procedures, and Good Clinical Practice (GCP) guidelines.
• Conducting regular site visits to monitor trial activities and data collection.
• Reviewing and analysing clinical trial data for accuracy and completeness.
• Developing and maintaining study timelines and budgets.
• Providing training to study staff on study protocols and GCP guidelines.
• Reviewing and approving study-related documents, such as informed consent forms.
• Conducting source data verification and ensuring data quality.
• Managing trial supplies and drug accountability.
• Serving as a liaison between study sites, sponsors and regulatory agencies.
Qualifications and Skills
• Bachelor's degree in a related field (e.g., Life Sciences, Pharmacy, Medical Sciences)
• A track record as a fractional / freelance CRA
• At least 5 years of experience working as a CRA
• Knowledge of regulatory requirements and guidelines, such as Good Clinical Practice (GCP) and International Council for Harmonization (ICH).
• Certification in clinical research, such as the Association of Clinical Research Professionals (ACRP) certification.
• Knowledge of clinical trial data management systems and electronic data capture.
• Experience with site selection, initiation, management, and monitoring activities.
• Strong attention to detail and accuracy in data management.
• Excellent communication and organizational skills
• Ability to work independently and remotely
• Knowledge of regulatory requirements in Malaysia and Thailand