FSP Clinical Research Associate II

2 weeks ago

Shanghai, Shanghai, China SHA Fortrea Pharmaceutical Research & Development (Beijing) Co Ltd Shanghai Branch Full time

Seeking a highly motivated Clinical Research Associate II to join our team at SHA Fortrea Pharmaceutical Research & Development (Beijing) Co Ltd Shanghai Branch. In this role, you will be responsible for all aspects of study site monitoring, including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits, and liaison with vendors.


Key Responsibilities:



  • Responsible for all aspects of study site monitoring, including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits, and liaison with vendors.
  • General on-site monitoring responsibilities.
  • Ensure the study staff who will conduct the protocol have received the proper material 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.
  • Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review.
  • Monitor data for missing or implausible data.
  • Ensure the resources of the Sponsor and Labcorp Drug Development are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Labcorp Drug Development travel policy.
  • 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.
  • 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 Visit (QC) when requested.
  • Recruitment of potential investigators, preparation of EC submissions, notification to regulatory authorities, translation of study related documentation, organization of meetings and other tasks as instructed by supervisor.
  • Track and follow up on Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAE.
  • Independently perform CRF review; query generation and resolution against established data review guidelines on Labcorp Drug Development 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 minimum of 1 (One) year of clinical monitoring experience is preferred, or an equivalent combination of education and experience to successfully perform the key responsibilities of the job can be substituted.
  • Ability to monitor study sites independently according to protocol monitoring guidelines, SOP and local regulatory Guidelines.
  • Have a full understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs.
  • Good planning, organization and problem solving skills.
  • Ability to work with minimal supervision.
  • Good communication and interpersonal skills.
  • Good analytical and negotiation skills.
  • Computer competency.
  • Fluent in local office language and in English, both written and verbal.
  • Works efficiently and effectively in a matrix environment.
  • 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.
  • Thorough knowledge of ICH Guidelines and understanding of local regulatory requirement.
  • Thorough knowledge of monitoring procedures.
  • Basic understanding of the clinical trial process.
  • Valid Driver's License.

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