General SummaryThe Clinical Research Associate II (CRA II) will monitor the progressof clinical studies at investigative sites or remotely, and ensure clinicaltrials are conducted, recorded, and reported in accordance with the protocol,standard operating procedures (SOPs), ICH-GCP, and all applicable regulatoryrequirements.

Keyresponsibilities

? Implementsand monitors local clinical trials to ensure sponsor and investigator obligationsare being met and are compliant with applicable local regulatory requirementsand ICH‐GCP guidelines

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

? Reviewsand verifies accuracy of clinical trial data collected, either onsite orremotely

? Providesregular site status information to team members, trial management, and updatestrial management tool.

? Completesmonitoring activity documents as required by Company or Sponsor SOPs or othercontractual obligations

? Worksclosely with other clinical team members to facilitate timely resolution oftrial and/or clinical issues

? Escalatessite and trial related issues per Company SOPs, until identified issues areresolved or closed

? Performsessential document site file reconciliation

? Performssource document verification and query resolution

? AssessesIP accountability, dispensation, and compliance at the investigative sites

? VerifiesSerious Adverse Event (SAE) reporting according to trial specifications andrelevant local and ICH GCP guidelines

? Communicateswith investigative sites

? Updatesapplicable tracking systems

? Ensuresall required training is completed and documented

? Beassigned logistical support tasks by CTM for Investigator Meetings

? Implements and monitors local/globalclinical trials to ensure sponsor and investigator obligations are being metand are compliant with applicable local regulatory requirements and ICH‐GCPguidelines

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

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

Job Factors (Knowledge, Skillsand Abilities)? Applies knowledge of Company s policies andprocedures? Demonstrates excellentwritten and oral communication? Demonstrates excellent knowledge of ICH/GCPand relevant local requirements? Displays ability to manage investigative sitesto facilitate trial deliverables? Demonstrates ability toescalate issues appropriately? Conducts monitoring to confirm subject safety and dataintegrity? Describesand demonstrates the principals of IP accountability9. Demonstratesworking knowledge of Microsoft Officeapplications? Demonstrates excellent knowledge of ICH GCP

? Identifies scientific misconduct at the site level

Demonstrates working knowledge ofClinical Trial Management Systems, e-TMF, IVRS/IWRS and Electronic Data CapturePlatforms Problem solving Fact Finding& Analysis

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

? Confirmsinvestigative sitesare following ICH/GCP

? Resolvesinvestigative site issues related to trial. Likely to involve seekingassistance from peers,quality assurance, teamlead, project management,subject matter experts and functional management to resolve more complex and difficult issues.

? Demonstratestrial system compliance and skills

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

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

Impact? Failure to adequatelymonitor and manage the investigative site could result is endangerment ofsubjects, safety, none valuable data, and failure to meet projecttimelines SupervisionGiven/Received

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

Sometimes instruction needed on routine work.

Qualifications

Undergraduatedegree 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

2 to 4 years oflocal trial experience; exposure to MNC and global trialsClinical research experienceKnowledge of ICH and local regulatory authority regulations regardingdrugAnadvanced degree (e.g., M.S.,M.B.A., PharmD, etc.)

上班地址：马当路388号SOHO复兴广场A座