CRA / SCRA

Department
部门

R&D

Title
职位
CRA / Sr. CRA
Starting Date
任职时间

–

Direct Report
直线经理
CRM
Direct Subordinates
直接下属
N/A
Primary Function
主要职能

Support (Sr.) Project manager / (Asso.) Project Management Director on Clinical projects to sets up, monitor and report in accordance with ICH/GCP, the company’s requirements and the local/regional regulation to achieve clinical operation and study target on timeline, quality and cost.

Major Responsibilities and Duties
主要职责和任务
  • Participates in the development of clinical trial documents in collaboration with the project manager.
  • Identifies and selects investigators/sites in collaboration with the project manager.
  • Prepares / collects all documents needed prior to study initiation.
  • Performs study feasibility visits in the investigational sites.
  • Organizes / participates in study site initiation visit in which are provided scientific and technical knowledge concerning the study procedures and its organisation.
  • Ensures monitoring follow up:
    • Maintain the relationship with the investigational site.
    • Follow up of trial progress and quality control of data (source document check).
    • Documentation of protocol violations, adverse events and premature treatment cessation.
    • Identification and resolution of all problems: logistical, methodological, human technical, which occur during the trial.
    • Management of the local trial files.
    • Management of the investigator’s trial file.
    • Management of trial related logistics.
    • Detection and reporting of deviations, finding and implementing corrective measures.
  • Provides timely monitoring reports for all visits / contacts in appropriate reports.
  • Performs study close out visits to close investigational site.
  • Prepares, organizes and participates in investigator’s meetings.
  • Manage study TMF filing and archiving.
  • Participates in internal & external education and training.
Qualifications
资格要求
  • Bachelor’s degree and above.
  • Major in clinical medicine, pharmacy and biology or relevant.
  • Have 2 years of relevant monitoring experience in clinical trial, and have knowledge reserve of clinical trial management specification (GCP).
  • Strong communication and coordination skills with internal /external clients.
  • Strong team spirit, sense of responsibility, proactive, careful and meticulous.
  • Good computer skills, including proficiency in Microsoft Word, Excel and PowerPoint.
  • Good oral and written communication skills.
  • Good organization and problem-solving skills.
  • Have a talent with effective time management.