(Clinical Research Associate)
The Clinical Research Associate (CRA) has the responsibilities for performing the assigned clinical research projects or tasks within their defined territory under the supervision of the (Associate) Clinical Research Manager (CRM)/(Associate) Clinical Research Director (CRD) or equivalence. Responsibilities of CRAⅠinclude performing site selection, initiation, monitoring, closeout of investigational sites, etc.
• Manage the assigned tasks or clinical projects in 100％ compliance with ICH-GCP, relevant SOPs, Local Regulations, other applicable laws and guidelines, and within the agreed timeline, including but not limited to:
Building relationships with investigators and site staff.
Conducting study feasibility survey and site selection.
Preparing required regulatory and IRB/IEC submissions.
Providing training to study staff on conducting the project.
Conducting local investigator meetings, study nurse/CRC training, and site Initiation.
Performing monitoring visits according to the approved Monitoring Plan.
Managing site Investigational Product (IP) supply management.
Conducting source data/document verification (SDV) in compliance with the Monitoring Plan and data review timelines.
Assisting and ensuring site staffs complete CRFs and answer data queries within the timeline defined in the Monitoring Plan.
Completing monitoring visit reports and required follow-up actions.
Ensuring compliance of pharmacovigilance and drug accountability.
Being responsible for the completeness and quality of the on-site files.
Identifying and resolving or escalating any issues to PM or CRM/ (A) CRD in a timely manner.
Closing out study sites on completion of the trial, and ensuring no outstanding open issues.
Maintaining and archiving study documentation and correspondence.
Preparing and attending audit and inspection as needed.
• Contribute to the establishment of a strong team spirit.
• Establish and maintain effective working relationships with other internal departments, including but not limited to: Medical Affairs, Regulatory Affairs, etc.
• Develop working relationships with regulatory authority and IRB/IEC personnel within the constraints of any local guidelines and regulations