Study Site Monitor

1 month ago

Pu Dong Xin Qu, China SHA Fortrea Pharmaceutical Research & Development (Beijing) Co Ltd Shanghai Branch Full time
Job Summary

SHA Fortrea Pharmaceutical Research & Development (Beijing) Co Ltd Shanghai Branch is seeking a highly motivated and experienced Clinical Research Associate to join our team. As a Clinical Research Associate, you will be responsible for monitoring clinical trials and ensuring the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools.

Key Responsibilities
  • Conduct routine monitoring and closeout of clinical sites, maintenance of study files, conduct of pre-study and initiation visits;
  • Liaise with vendors and other stakeholders as assigned;
  • Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study;
  • Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements;
  • Monitor data for missing or implausible data;
  • Ensure the resources of the Sponsor and Fortrea are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines;
  • Ensure audit readiness at the site level;
  • Travel, including air travel, may be required and is an essential function of the job;
  • Prepare accurate and timely trip reports;
  • Interact with internal work groups to evaluate needs, resources and timelines;
  • Act 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;
  • Undertake feasibility work when requested;
  • Participate in and follow-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;
  • Assist Senior CRA with managing investigator site budgets;
  • Track and follow-up on Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs;
  • Independently perform CRF review; query generation and resolution against established data review guidelines on Fortrea or client data management systems as assigned by management;
  • Assist with training, mentoring and development of new employees, e.g. co-monitoring;
  • Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contact as assigned;
  • Perform other duties as assigned by management.
Requirements
  • At least 1.5 years experience as CRA;
  • 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;
  • University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure). An equivalent amount of experience can be substituted as appropriate;
  • Basic knowledge of Regulatory Guidelines;
  • Basic understanding of the clinical trial process;
  • Fluent in local office language and in English, both written and verbal.

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