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Clinical Research Associate

4 months ago

Singapur, Singapore Amaris Consulting Full time
Job description

Amaris Consulting is a leading global pharmaceutical and clinical research organization dedicated to advancing healthcare through innovative research and development. Our team is composed of passionate professionals committed to improving patient outcomes and advancing medical science.

Position Overview:

We are seeking an experienced Clinical Research Associate (CRA) with 4-6 years of industry experience to join our dynamic team. The ideal candidate will be responsible for managing and monitoring clinical trials, ensuring compliance with regulatory requirements, and maintaining high standards of quality and integrity in clinical research. This role involves collaboration with cross-functional teams and requires travel to various sites within the designated region.

Key Responsibilities:

1. Study Management:

  • Conduct site feasibility and selection processes.
  • Plan, organize, and oversee the initiation, monitoring, and closure of clinical trials.
  • Ensure all study protocols and regulatory requirements are adhered to at each site.

2. Monitoring Activities:

  • Perform regular site visits to monitor study progress, data collection, and compliance.
  • Verify the accuracy, completeness, and consistency of clinical data reported.
  • Ensure the proper storage and handling of investigational products.

3. Regulatory Compliance:

  • Ensure all activities comply with ICH-GCP guidelines, local regulations, and company SOPs.
  • Prepare and review regulatory documentation and submissions.

4. Communication and Collaboration:

  • Serve as the primary point of contact between the sponsor and investigational sites.
  • Facilitate effective communication among study sites, investigators, and project teams.
  • Provide regular updates and reports on study progress to project managers and stakeholders.

5.Documentation and Reporting:

  • Maintain accurate and complete study files and documentation.
  • Prepare monitoring reports, follow-up letters, and study-specific documents.
  • Assist in the preparation of study-related documents for audits and inspections.

6. Training and Support:

  • Provide training and support to site staff on study protocols, procedures, and requirements.
  • Assist in the development and implementation of training materials and programs.

Qualifications:

  • Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field; advanced degree preferred.
  • 4-6 years of clinical research experience, preferably within a CRO or pharmaceutical company.
  • Comprehensive knowledge of ICH-GCP guidelines and local regulatory requirements.
  • Proven experience in monitoring clinical trials and managing study sites.
  • Strong organizational and problem-solving skills.
  • Excellent communication and interpersonal skills.
  • Proficiency in using clinical trial management systems (CTMS) and electronic data capture (EDC) tools.
  • Willingness to travel extensively within the designated region (up to 70%).

Preferred Skills:

  • Experience in specific therapeutic areas such as oncology, cardiology, or neurology.
  • Fluency in multiple languages relevant to the location (e.g., Mandarin for China, German/French for Europe).
  • Advanced training in clinical research methodologies and regulations.

What We Offer:

  • Competitive salary and comprehensive benefits package.
  • Opportunities for professional growth and development.
  • Supportive and collaborative work environment.
  • Access to cutting-edge research and development projects.

Amaris Consulting is proud to be an equal-opportunity workplace. We are committed to promoting diversity within the workforce and creating an inclusive working environment. For this purpose, we welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.