Clinical Research Associate-Guangzhou-Flex

Novotech

广东省广州市
长期
全职

21天前

Job Description:Responsibilities:

Contribute comments/input in the development of Protocol, Informed Consent Form(ICF), Case Report Forms (CRF) and other project related documents.
Evaluation potential sites with the assistance from PM or line manager and provide PM with recommendations for selection of qualified sites.
Prepare the package for institutional review boards (IRB) and local regulatory authority submissions and obtain IRB/regulatory approvals for conducting the clinical trial.
Assist PM in start-up meeting. Participates in investigator meetings as necessary.
Prepare and manage the clinical trial agreements with investigators/sites.
Track, manage and control the site budget and expenses within approved budget and in line with the project milestones as requested.
Manage/coordinate the investigational products and clinical trial materials for the sites in compliance with regulatory requirements.
Monitor and report the project status at the sites in a timely manner.
Key contact person for the communication between the sites and study team.
Prepare, arrange and conduct the training of site personnel.
Conduct site initiation, monitoring and site close-out visits in compliance with monitoring plan, ICH-GCP, SOPs, local regulations and other applicable project-specific plans.
Prepare monitoring report according to the SOP.
Assist the investigator for auditing/inspection of project.
Coordinate with the sites to ensure all adverse events and follow-up are appropriately reported and reconciled according to regulations
Identify, analyze and resolve the issues at the investigator sites.

Qualifications:Education and Experience:

A 4-year BS (Bachelor of Science) degree or equivalence experience. Advanced degree is a plus.

Skills and Competencies:

Good command of written and spoken in English or other second language.
Good organization and communication skills.
High attention to detail and accuracy.
Demonstrated ability to attain and maintain a working knowledge of GCPs and applicable SOPs.

About Us: Novotech has offices in 11 geographies across the region, and site partnerships with key medical institutions.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.About the Team: Novotech is a leading Asia-Pacific biotech specialist CRO and consists of two operating brands, Novotech and PPC. Novotech is a clinical CRO with labs, phase I facilities, and drug development consulting services.It has accumulated experience in over 3,700 clinical projects, including Phase I to Phase IV clinical trials and bioequivalence studies. Novotech is positioned to serve biopharmaceutical clients conducting clinical trials in Asia and globally.As of September 30, 2021, Novotech had over 2,750 FTEs across 11 geographies in Asia-Pacific, the United States and the UK.

Novotech

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