Contract Clinical Research Associate
CLINIPACE
Tokyo, Japan
6 日前

Job Duties and Responsibilities :

  • Provides support to Project Team and Clinical Operations Team.
  • Maintains working knowledge of protocols and Monitoring Plans for assigned projects.
  • Demonstrates good written and verbal communication skills.
  • Serves as primary contact for assigned research sites.
  • Verifies that the investigator, staff, and site facilities remain adequate throughout the trial period.
  • Responsible for scheduling and conduct of pre-study visits, initiation visits, interim monitoring visits and close-out visits according to the Monitoring Plan.
  • Ensures assigned sites are conducting studies according to protocol requirements or investigational plan and applicable regulations and guidelines.
  • Verifies that the rights and well-being of trial subjects are protected.
  • Reconciles site regulatory binder assuring collection and completeness of regulatory documents.
  • Collects and ensures completeness of all essential regulatory documentation from sites from study start-up through close-out.
  • May support translations of essential documents.
  • May support submission of trials to IRB / IEC and regulatory authorities.
  • Verifies that written informed consent was obtained before each subject’s participation in the trial.
  • Verifies that the investigator is enrolling only eligible subjects.
  • Performs source data verification against Case Report Form / Electronic Data Capture entries in compliance with the Monitoring Plan.
  • Ensures accurate and complete data and that corrections are appropriately documented by authorized site staff.

  • Verifies the quality of all recorded data. Issues and ensures timely resolution of all data queries remotely or at investigator site.
  • Performs Investigational Product accountability, including product storage, inventory, return / destruction, and dispensing / receipt records.
  • Verifies and supports the recording and reporting of adverse events / serious adverse events. Ensures all types of adverse events are reported and tracked per regulatory requirements and the Monitoring Plan.
  • Ensures that sites have sufficient project specific supplies.
  • Manages investigative sites in respect to the trial conduct and motivates sites to meet study goals.
  • Communicates deviations from the protocol, SOPs, and / or GCP, to the investigator, and project management team and takes appropriate action to prevent recurrence.
  • Delivers quality written trip reports, confirmation and follow-up letters within timelines of SOPs and Monitoring Plans.
  • Attends and participates in team teleconferences and training.
  • Participates in relevant trial meetings, e.g. Kick-off, Investigator and Monitor meetings.
  • Participates in site audits, as requested.
  • May conduct site and study feasibility assessments.
  • May be involved in the development of monitoring guideline and tools.
  • May provide input into study documentation and monitoring worksheets.
  • Uphold the confidentiality agreements with all clients and colleagues outside Clinipace.
  • Pays attention to signals of fraud, misconduct and escalates per Clinipace SOP.
  • Work according to the Clinipace Quality Management System and actively participate in giving feedback and suggesting improvements to current processes.
  • Work according to the project-specific timelines and budget agreement, which has been agreed upon with the sponsor. Accurately document the time spent per project in the Clinipace time allocation system.
  • Demonstrates flexibility and adaptability.
  • Proactively identifies, manages, escalates (as needed) and resolves site issues effectively and independently.
  • Other duties as assigned by Clinical Operations Manager / Project Manager per project-specific requirements.
  • Supervisory Responsibilities : None

    Job Requirements :

  • Education 4 year college graduate, preferably with a healthcare or life science degree. In lieu of a degree, candidates with 1 or more years of relevant clinical research experience in pharmaceutical or CRO industries will be considered.
  • Experience Less than 1 year of experience in on-site monitoring clinical studies.
  • Skills / Competencies Good communication and interpersonal skills Good monitoring skills to independently conduct all types of site monitoring visits Proficient computer skills, including Microsoft Office Comprehensive knowledge of GCP / ICH guidelines Proficiency in medical terminology Able to exercise judgment within defined procedures and practices and to determine appropriate action independently.
  • Attention to detail Problem-solving skills Ability to work in a matrix environment Good time management and organizational skills Good documentation skills;
  • good command of English and the local language in the area of activity (reading, writing, understanding)

  • Capabilities Ability to drive an automobile and have a valid driver’s license, if applicable Valid passport required in the case of international business travel.
  • Ability to travel up to 80%.

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