Address
Form of workJob Title: Clinical Trial Assistant/Senior Clinical Trial Assistant
Report Line: Director, Clinical Development
Location: Sydney, Australia Department Clinical Development
PLEASE NOTE - we only accept applicants who live in Sydney Australia only as this is an office-based role. Thank you.
Purpose of Job
• Administrative support to clinical trials in compliance with Standard Operating Procedures (SOPs), ICH-GCP and local regulations.
• Ensures clinical trials are monitored such that subjects' rights, safety and well being are protected and that the clinical trial data are reliable
Primary Duties and Responsibilities
• Provide the administrative support to the clinical research teams in the full spectrum of the research activities such as study start up, site management and site closure.
• Assist in gather and the preparation of documents for clinical trial applications for the submission and approval from the competent authority and ethical committees.
• Responsible for the correct filing and archiving of clinical trial documents, and the maintenance of study files.
• Provide support in meeting activities such as organizing and planning of meetings (e.g. investigator-, project-, team- meetings), and provide meeting minutes.
• Administrative support includes implementation of new CTMS system, project tracking, maintenance of eTMF
• Liaise with cross-functional project team to support the management of clinical projects e.g. communicate with Science, Medical, Data Management, IP teams within organization
• May liaise with vendors as needed e.g. central lab, IP distributor, CRO
• May interact with sites and co-monitor as needed
• Provide administrative support in implementation of organizational initiatives and priorities
Qualification
• Degree in life sciences or related fields.
• Basic knowledge of clinical trial processes and ICH/GCP guidelines.
• Strong general administration skills and experience.
• Proficient in the use of Microsoft Office.
• Well organized with good time management skills.
• Strong interpersonal and communication skills
• Strong written and verbal communication skill
To apply for this role please send your CV/Resume along with a cover letter to **********@ascentage.com. Please Reference: “Senior/Clinical Trial Assistant” in the Subject Line.
EEO Statement
Ascentage Pharma Group Inc. is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
