Assisting PI to administer the clinical trials in accordance with the SOP, ensuring the clinical trials are conducted in accordance with GCP guidelines and quality.
Major Responsibilities
Describe the tasks, duties, and responsibilities the employee who is working on this role is supposed to carry out. List the responsibilities in the order of their importance.
- Follow the assignment and direction by director of department.
- Site Start-up:
- Documents Submission and Kick off meeting.
- Site start-up.
- Project Execution and Management:
- ICF Management.
- Assist in the screening, enrollment, and follow-up visit of subjects.
- Subject noncompliance behavior management.
- Data collection and source data management.
- Trail drug management.
- To monitor with CRA, QA, and QC.
- Data entry and management:
- Data collection and source document management.
- Data Entry.
- Assist AE, SAE, PD record and report.
- Site Close-out.
- Administering the clinical trial properly and assisting to solve problems.
- Support other colleagues to implement ongoing projects or affairs. Participate voluntarily in all kinds of works and various activities of department.
- Participate in audit by customer and regulatory agencies.
- Assist in project quality, schedule, resource allocation and management.
- Perform the tasks assigned by line manager.
- Organizing, stamping, distributing, sending, and retaining documents, etc (Administrator).
- Clinical Research Coordinator Trainee:
- Complete various types of coaching and training assigned by the company.
- Complete the GCP internal exam.
- Participation in project practice activities under compliance.
Qualifications & Experience
Education
- College above, graduated in Medicine, Nursing, and Pharmacology related departments graduation.
Knowledge, Skills, and Abilities
- Provided with knowledge of GCP.
- Good command of English.
- Familiar with office and Project software.
Experiences
- Senior Clinical Research Coordinator:
- 2 years and above working experience as CRC or in clinical research industry is preferred.
- Clinical Research Coordinator II:
- 1 year and above working experience as CRC or in clinical research industry is preferred.
- Clinical Research Coordinator I:
- Half a year and above working experience as CRC or in clinical research industry is preferred.
Novotech is a global full-service clinical Contract Research Organization (CRO).
Headquartered in Sydney, Australia, Novotech has 34 offices across Asia-Pacific, North America, and Europe. Novotech employs over 3000 employees and has over 5000 site partnerships and the resources and infrastructure to scale regionally and globally as clinical programs advance.
Novotech provides clinical development services across all clinical trial phases and therapeutic areas including feasibility assessments, ethics committee and regulatory submissions, data management, statistical analysis, medical monitoring, safety solutions, central lab services, report write-up to ICH requirements, project and vendor management. Novotech obtained the ISO 27001 certification which is the best-known standard in the ISO family providing requirements for an Information Security Management System. Together with the ISO 9001 Quality Management system, Novotech aims at the highest IT security and quality standards for patients and biotechnology companies.
