Monitor and Manage Clinical Trials

1 day ago

Singapore beBeeClinicalResearch Full time $80,000 - $110,000
Job Title

Clinical Research Associate II is a vital role within the Clinical Operations group, overseeing site management, monitoring tasks, and operational support of clinical trials.

Responsibilities:
  • Coordinate investigator and site selection for trials, assessing feasibility and identifying suitable candidates.
  • Complete monitoring activities as per Monitoring Plan, producing accurate visit reports within predetermined timeframes.
  • Prepare and conduct site evaluation visits, reporting on these to inform site selection decisions.
  • Liaise with regulatory specialists regarding regulatory package preparation, import/export requirements, and Ethics Committee updates.
  • Negotiate budgets, coordinate contract execution, track invoicing, and ensure timely payments.
  • Develop and maintain monitoring tools and project-specific documents, ensuring compliance and quality.
  • Motivate and train investigators to understand protocol, investigational product, and trial requirements, promoting adherence and accuracy.
  • Collect, review, and approve essential documents from trial sites, coding documents for Trial Master File filing.
  • Reconcile TMF contents with Investigator Site Files, ensuring accuracy and completeness.
  • Coordinate distribution, tracking, handling, and destruction of investigational product and trial supplies.
  • Maintain trial information using clinical trial management systems and tracking tools.
  • Support recruitment efforts through strategic planning.
Qualifications / About You:
  • Hold tertiary qualifications in a related science or healthcare discipline.
  • Prior experience in clinical trials, preferably in academic, CRO, or pharmaceutical environments, with 3-5 years of monitoring and site management experience.
  • Demonstrate practical knowledge of ICH-GCP guidelines and global/local ethical and regulatory research requirements.
  • Display competence in ethical considerations, site start-up management, risk management, quality management, scientific concepts, and issue escalation.
  • Competence in business skill areas: negotiation, conflict resolution, critical thinking, problem-solving, decision making, and strategic thinking.
  • Strong interpersonal communication, presentation skills, and flexibility in working within a multi-disciplinary team.
  • Ability to adapt to changing priorities and ambiguous environments.
  • Willingness to travel.
Why Work With Us:
  • Contribute to life-improving clinical trials, focusing on therapies in renal, cardiometabolic, and oncology.
  • Global reach, local expertise, building trust and engagement with local communities.
  • Culturally diverse and innovative environment, valuing perspectives and creative solutions.
  • Competitive compensation and benefits package, tailored to skills and experience.
  • Hybrid or remote working arrangements, depending on location and role.
  • Access to learning opportunities and a global network of scientific leaders, promoting growth and development.
  • Employee wellbeing initiatives, promoting work-life balance, health, and team connection.
  • Global opportunities, exposure to diverse projects and clients.

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