General Summary The Clinical Research Associate II (CRA II) will monitor the progress of clinical studies at investigative sites or remotely, and ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements. Key responsibilities

? Implements and monitors local clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH‐GCP guidelines

? Assesses the qualification of potential investigative sites, initiates clinical trials at investigative sites, instructs site personnel on the proper conduct of clinical trials, and close clinical trials at investigative sites

? Reviews and verifies accuracy of clinical trial data collected, either onsite or remotely

? Provides regular site status information to team members, trial management, and updates trial management tool.

? Completes monitoring activity documents as required by Company or Sponsor SOPs or other contractual obligations

? Works closely with other clinical team members to facilitate timely resolution of trial and/or clinical issues

? Escalates site and trial related issues per Company SOPs, until identified issues are resolved or closed

? Performs essential document site file reconciliation

? Performs source document verification and query resolution

? Assesses IP accountability, dispensation, and compliance at the investigative sites

? Verifies Serious Adverse Event (SAE) reporting according to trial specifications and relevant local and ICH GCP guidelines

? Communicates with investigative sites

? Updates applicable tracking systems

? Ensures all required training is completed and documented

? Be assigned logistical support tasks by CTM for Investigator Meetings

? Implements and monitors local/global clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH‐GCP guidelines

? Manage the essential documents, as required by local regulations and ICH GCP, before, during and after a clinical trial. Facilitates audit s and audit resolution

? Assesses the qualification of potential investigative sites, initiates clinical trials at investigative sites, instructs site personnel on the proper conduct of clinical trials, and close clinical trials at investigative sites

Job Factors (Knowledge, Skills and Abilities)

Knowledge & Skills

? Applies knowledge of Company s policies and procedures

? Demonstrates excellent written and oral communication

? Demonstrates excellent knowledge of ICH/GCP and relevant local requirements

? Displays ability to manage investigative sites to facilitate trial deliverables

? Demonstrates ability to escalate issues appropriately

? Conducts monitoring to confirm subject safety and data integrity

? Describes and demonstrates the principals of IP accountability9. Demonstrates working knowledge of Microsoft Office applications

? Demonstrates excellent knowledge of ICH GCP

? Identifies scientific misconduct at the site level

? Demonstrates working knowledge of Clinical Trial Management Systems, e-TMF, IVRS/IWRS and Electronic Data Capture Platforms

Problem solving Fact Finding & Analysis

? Confirms investigative sites are appropriately utilizing protocol and trial process for trial conduct

? Confirms investigative sites are following ICH/GCP

? Resolves investigative site issues related to trial. Likely to involve seeking assistance from peers, quality assurance, team lead, project management, subject matter experts and functional management to resolve more complex and difficult issues.

? Demonstrates trial system compliance and skills

? Resolves investigative site issues related to trial with assistance from peers, quality assurance, team lead, project management, subject matter experts and functional management

? Utilizes Company systems to analysis investigative site metrics (i.e. backlog, enrollment, protocol deviations, and audits.) to appropriately manage the site

Impact

? Failure to adequately monitor and manage the investigative site could result is endangerment of subjects, safety, none valuable data, and failure to meet project timelines

Supervision Given/Received

? Supervision under the guidance of functional manager, CTM and /or tenured SCRAs.

Sometimes instruction needed on routine work.

Qualifications

Education

? Undergraduate degree or its international equivalent in clinical, science, or health‐related field from an accredited institution; a licensed health‐care professional (i.e., registered nurse); or equivalent work experience required

Experience

? 2 to 4 years of local trial experience; exposure to MNC and global trials

Preferred Education and/or Experience

? Clinical research experience

? Knowledge of ICH and local regulatory authority regulations regarding drug

? An advanced degree (e.g., M.S.,M.B.A., PharmD, etc.)

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