Job Description

The Researcher is responsible for the conduct of analysis related works according to GCP, GLP, CAP, Standard Operating Procedures (SOP), applicable Study Specific Procedures (SSP), and local regulatory requirements.

Manage the operation of MT and aid physicians in the diagnosis, treatment, and prevention of diseases by testing patient specimens, correlating data, and reporting results in a timely manner to effect quality patient care.

Major Responsibilities

• Conduct analysis work following related SOPs and guidance.
• Draft/check/review/approve documents, such as SOP, protocol, analytical result, report and method.
• Involve in lab logistics (general affair) management, such as purchasing, inventory controlling, payment applying.
• Responsible for instrument maintenances, workspace cleaning/maintenance.
• Delegated/assigned as the system owner for computerized system, do the corresponding work for system, such as validation test, periodic review, report, etc.
• Participate in CAP/GCP/GLP/regulatory related training courses.
• Provide temporary supporting assigned by line manager.
• Involve in sample collection kit/label preparation.
• Involve in analytical study project management.
• Refer to additional Study Based Responsibilities while being assigned in GLP project.

Study Based Responsibility (if needed)

Analytical Study Director in Study

• Per management's assignment, work as the Study Director, who is the single point of study control and has the responsibility for the overall conduct of the study and for its final report.
• Approve the study plan and any amendments to the study plan by dated signature.
• Ensure that the Quality Assurance personnel have a copy of the study plan and any amendments in a timely manner and communicate effectively with the Quality Assurance personnel as required during the conduct of the study for regulatory submission.
• Ensure that study plans and amendments and Standard Operating Procedures are available to study personnel.
• Ensure that the procedures specified in the study plan are followed, and assess and document the impact of any deviations from the study plan on the quality and integrity of the study, and take appropriate corrective action if necessary; acknowledge deviations from Standard Operating Procedures during the conduct of the study.
• Ensure that all raw data generated are fully documented and recorded.
• Ensure that computerized systems used in the study have been validated.
• Sign and date the final report to indicate acceptance of responsibility for the validity of the data and to indicate the extent to which the study complies with these Principles of Good Laboratory Practice.
• Ensure that after completion (including termination) of the study, the study plan, the final report, raw data and supporting material are archived.

Study Personnel in Study

• All personnel involved in the conduct of the study must be knowledgeable in those parts of the Principles of Good Laboratory Practice which are applicable to their involvement in the study.
• Study personnel will have access to the study plan and appropriate Standard Operating Procedures applicable to their involvement in the study. It is their responsibility to comply with the instructions given in these documents. Any deviation from these instructions should be documented and communicated directly to the Study Director, and/or if appropriate, the Principal Investigator(s).
• All study personnel are responsible for recording raw data promptly and accurately and in compliance with these Principles of Good Laboratory Practice, and are responsible for the quality of their data.
• Study personnel should exercise health precautions to minimize risk to themselves and to ensure the integrity of the study. They should communicate to the appropriate person any relevant known health or medical condition in order that they can be excluded from operations that may affect the study.

Qualifications & Experience

Education

• A 4-year BS (Bachelor of Science) degree in Biochemistry, Biotechnology and Laboratory Science, Chemistry, or a related field. Or Junior colleague with over 3-year lab work experience and well qualified. Advanced degree is a plus for Associate Researcher/ Senior Researcher.
• License of Medical Technician is required for Associate Researcher/ Senior Researcher in Central Lab.

Knowledge, Skills, and Abilities

• Familiar with all lab operation activities.
• Excellent working knowledge of CAP/GCP, applicable law (local and country) and regulatory requirements.
• Good communication skills.
• Good verbal and written English or other second language skills.
• Good problem-solving skills.
• Effective time management and prioritization skills.

Experiences

• Prefer with over 3-year lab work experience and well qualified.

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.