Clinical Research Associate

3 weeks ago

Guangzhou, Guangdong, China SGA Fortrea Pharmaceutical Research & Development (Beijing) Co Ltd, Guangzhou Branch Full time

About the Role

This position is responsible for all aspects of study site monitoring, including routine monitoring and closeout of clinical sites, maintenance of study files, conduct of pre-study and initiation visits, and liaison with vendors. The ideal candidate will have six months of experience in a related role and a basic understanding of regulatory guidelines.

Responsibilities

This role will involve:

  • Ensuring the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study
  • Ensuring the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements
  • Ensuring the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review
  • Monitoring data for missing or implausible data
  • Ensuring the resources of the Sponsor and Covance are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines
  • Ensuring audit readiness at the site level
  • Travel, including air travel, may be required and is an essential function of the job
  • Preparing accurate and timely trip reports
  • Interacting with internal work groups to evaluate needs, resources, and timelines
  • Acting as contact for clinical trial supplies and other suppliers (vendors) as assigned
  • Responsible for all aspects of registry management as prescribed in the project plans
  • Undertaking feasibility work when requested
  • Participating in and following up on Quality Control Visits (QC) when requested
  • Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings, and other tasks as instructed by supervisor as assigned
  • Assisting Senior CRA with managing investigator site budgets
  • Tracking and following up on Serious Adverse Event (SAE) reporting, process production of reports, narratives, and follow-up of SAEs
  • Independently performing CRF review; query generation and resolution against established data review guidelines on Covance or client data management systems as assigned by management
  • Assisting with training, mentoring, and development of new employees, e.g., co-monitoring
  • Coordinating designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contact as assigned
  • Performing other duties as assigned by management

Requirements

The ideal candidate will have:

  • Six (6) months experience in a related role (e.g., site management, in-house CRA, study coordinator, research nurse, etc.)
  • Basic understanding of Regulatory Guidelines
  • Ability to work within a project team
  • Good planning, organization, and problem-solving skills
  • Good computer skills with good working knowledge of a range of computer packages
  • Works efficiently and effectively in a matrix environment
  • Valid Driver's License

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