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Clinical Research Associate

2 months ago

Singapore PRESTIGE BIOPHARMA LIMITED Full time
Job Title: Clinical Research Associate

Prestige Biopharma Limited is seeking a highly skilled Clinical Research Associate to join our team. As a Clinical Research Associate, you will play a critical role in the success of our clinical trials.

Key Responsibilities:
  • Protocol Review: Conduct thorough reviews of study protocols to ensure compliance with regulatory requirements and Good Clinical Practice (GCP) guidelines.
  • Site Selection: Collaborate with cross-functional teams to select suitable clinical trial sites and investigators.
  • Regulatory Compliance: Ensure that all clinical trials are conducted in accordance with relevant regulations and guidelines.
  • Site Initiation: Conduct site initiation visits to train investigators and site staff on protocol requirements and data collection procedures.
  • Monitoring: Regularly visit clinical trial sites to monitor study conduct, data accuracy, and participant safety.
  • Data Collection and Management: Oversee the collection, documentation, and verification of clinical trial data.
  • Safety Reporting: Monitor and report adverse events, protocol deviations, and other safety-related issues.
  • Communication: Maintain regular communication with investigators, site staff, and study sponsors to ensure smooth trial progress.
  • Documentation: Maintain and review essential documents to ensure compliance.
  • Close-Out Visits: Conduct close-out visits to ensure all required documentation is complete and study materials are returned.
  • Quality Assurance: Collaborate with quality assurance teams to ensure clinical trial processes adhere to quality standards.
Requirements:
  • Education: A bachelor's degree in a relevant scientific or healthcare field.
  • Clinical Research Certification: Certified Clinical Research Professional (CCRP) or SoCRA certification is a plus.
  • Experience: Minimum 2 years of clinical monitoring experience in oncology trials.
  • Knowledge of Regulations and Guidelines: A good understanding of GCP guidelines, relevant regulatory requirements, and other guidelines governing clinical research.
  • Attention to Detail: Strong attention to detail to ensure accuracy in data collection and compliance with protocols.
  • Communication Skills: Effective communication with study site personnel, investigators, and sponsors.
  • Organizational Skills: Strong organizational skills to keep track of various aspects of the clinical trial.
  • Problem-Solving Skills: The ability to identify and resolve issues or challenges that may arise during the course of a clinical trial.
  • Teamwork: Ability to collaborate effectively with various stakeholders.
  • Ethical Conduct: Possess high ethical standards to ensure the safety and well-being of study participants and the integrity of the clinical trial data.
  • Computer Skills: Proficiency in using various computer applications and clinical trial management systems.
  • Travel Availability: Willingness and ability to travel to different clinical trial sites.
  • Adaptability: Able to adapt to changes in study protocols, regulations, or project requirements.