Clinical Research Associate

4 days ago

Singapur, Singapore PRESTIGE BIOPHARMA LIMITED Full time
Roles & Responsibilities

Job Description & Requirements


Job Description

  • Protocol Review: Review and understand the study protocol, which outlines the objectives, design, methodology, and conduct of the clinical trial.
  • Site Selection: Participate in the selection of appropriate clinical trial sites and investigators based on their qualifications and ability to conduct the study.
  • Regulatory Compliance: Ensure that the clinical trial is conducted in compliance with relevant regulatory requirements, including Good Clinical Practice (GCP) guidelines. Assist in the preparation for and conduct of regulatory inspections.
  • Site Initiation: Conduct site initiation visits to train investigators and site staff on the protocol, regulatory requirements, and data collection procedures.
  • Monitoring: Regularly visit clinical trial sites to monitor the conduct of the study, including the verification of data accuracy, participant safety, and protocol adherence.
  • Data Collection and Management: Oversee the collection, documentation, and verification of clinical trial data, ensuring that it is accurate, complete, and in compliance with the protocol.
  • Safety Reporting: Monitor and report adverse events, protocol deviations, and other safety-related issues in accordance with regulatory requirements.
  • Communication: Maintain regular communication with investigators, site staff, and study sponsors to address queries, provide guidance, and ensure the smooth progress of the trial.
  • Documentation: Maintain and review essential documents, such as informed consent forms, ethics committee approvals, and other regulatory documents, to ensure compliance.
  • Close-Out Visits: Conduct close-out visits to ensure that all required documentation is complete, and study materials are returned, and provide support for the finalization of the study report.
  • Quality Assurance: Collaborate with quality assurance teams to ensure that the clinical trial processes adhere to quality standards and are audit-ready.
  • Training: Provide training and support to site personnel on an ongoing basis to maintain protocol adherence and data integrity.

Job Requirements

  • Education: A bachelor's degree in a relevant scientific or healthcare field. Degree in pharmacy, nursing, or MBBS preferred.
  • Clinical Research Certification: Certified Clinical Research Professional (CCRP) or the Society of Clinical Research Associates (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 Good Clinical Practice (GCP) guidelines, relevant regulatory requirements (such as FDA regulations), 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. Able to convey complex information clearly and professionally.
  • 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.
  • Teamwork: Ability to collaborate effectively with various stakeholders, including investigators, study coordinators, and sponsors.
  • Ethical Conduct: Posses 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.

Tell employers what skills you have

FDA
Regulatory Compliance
Strong Attention To Detail
Clinical Research
Quality Assurance
Site Management
Healthcare
Oncology
Protocol
Adaptability
Trials
Nursing
Wellbeing
Regulatory Requirements
Clinical Monitoring
Trial Management

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