Description
As a member of the research team at the research centre, you will coordinate and execute assigned clinical trials according to the study protocol, agreed upon scope of work, GCP, sponsor/company SOPs, and relevant guidelines and regulations.
Responsibilities:
- Work as a research team member at the research centre, following regulatory requirements, agreed upon scope of work, applicable SOPs, work authorizations, and study protocols.
- Assist investigators with feasibility questionnaires and case report forms.
- Facilitate site initiation: assist sites with screening visits, submission of documents to ethics committees for approval, and dispensing of investigational products.
- Assist investigators with subject screening and enrolment.
- With investigator authorization, assist with follow-up visits and procedures as required by the protocol, including scheduling, inventory checks, and other coordination tasks.
- Manage investigational products, study materials, and laboratory samples at the research centre.
- Participate in investigator meetings, monitoring visits, audits, and other meetings within the agreed upon scope of work.
- Assist investigators with archiving study documents and submitting them to ethics committees or other authorities.
- Accurately transcribe data from source documents to case report forms and assist with query resolution.
- Facilitate site closure: assist sites with closure visits, collection of investigational products and study materials, and archiving of study documents.
- Create and maintain routine reports and other work-related documents.
- Travel to other cities may be required as needed.
Requirements:
- Basic knowledge of clinical research and applicable regulatory requirements.
- Familiarity with medical terminology.
- Good communication and organizational skills.
- Proficient in Microsoft Office software.
- Fluent in Chinese, with basic English proficiency.
- Ability to work independently, prioritize tasks, and solve problems.
- Strong confidentiality skills.
Education and Experience:
- Associate's degree or higher in clinical medicine, pharmacology, nursing, healthcare, or related field.
- Less than 1 year of experience as a clinical research coordinator.
- Experience working in clinical research or the pharmaceutical industry.