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Offers “Abbott”

days ago Abbott

Clinical Research Associate

  • First ( Bezirk Pfäffikon )
  • Logistics

Job description

JOB DESCRIPTION:

RESPONSIBILITIES:

  • Support selection of clinical research centers.
  • Perform clinical research site assessment to evaluate the expected performance level for a specific protocol (e.g. medical expertise, facilities, compliance and enrollment rate).
  • Be an efficient communication link between the European clinical research department and the clinical research centers.
  • Developing/maintaining relationships with Key Opinion Leaders (KOL).
  • Collect essential documents for clinical research site.
  • Work with site and local Regulatory Affairs representative (if applicable) to prepare Ethic Committee submission and obtain approval(s).
  • Follow Competent Authority notification and submission (with PM and local Regulatory Affair representative or local clinical research department).
  • Site Initiation for clinical Studies in compliance with company SOPs, ISO 14155, monitoring plan and applicable local and international regulations.
  • Organize and perform site training on all aspects of the respective clinical study, including clinical investigational plan, informed consent process, investigational device, A(D)E/SA(D)E reporting, handling of deviations and study procedures including (e)-CRF, compliance, randomization service and other applications if applicable.
  • Address site authorization process and investigator responsibilities.
  • Conduct Interim Monitoring of clinical trials in compliance with company SOPs, ISO 14155, monitoring plan and applicable local and international regulations.
  • Review progress of the trial and report.
  • Source data verification (compare original patient data to CRF entries).
  • CIP compliance and deviation handling.
  • Inventory control (where applicable).
  • A(D)E/SA(D)E reporting.
  • CRF completion and adherence to data collection guidelines.
  • Subject recruitment process and consenting process.
  • Review study documentation and retention.
  • Staff changes, if yes, supply additional training.
  • Follow up of action items and corrective actions.
  • Reporting to ethical committee of safety and protocol deviations.
  • Conduct Final Monitoring of clinical trials in compliance with company SOPs, ISO 14155, monitoring plan and applicable local and international regulations.
  • All unresolved issues must be addressed and the CRF must be complete, accurate, and signed by the Investigator.
  • All study site documents will be reviewed, filed, and prepared for archiving.
  • Inventory will be reconciled and removed from the site after patient inclusion has been completed (where applicable).
  • Coordinate that study material will be returned to Abbott Vascular.

REQUIREMENTS:

  • Strong organizational, planning and prioritization skills and can function as part of a Team.
  • Excellent verbal and written communication skills.
  • Customer focused.
  • Self motivated.
  • Problem identification and solving skills.
  • Detail and quality oriented.
  • Stress management techniques.
  • Ability to understand and to follow work processes (SOPS, guidelines, protocols) within the assigned function.
  • Bachelor’s degree with related work experience preferred or an equivalent combination of education and work experience.
  • Refer to CRA Level Description Matrix for additional requirements.
  • Fluent in English.
  • Computer literate.
  • Ability to travel.
  • Flexibility.
  • Able to work in international environment / Diversity.

JOB FAMILY:

Research and Discovery

DIVISION:

LOCATION:

China > Beijing : 27 Dong San Huan Bei Lu

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Not specified

MEDICAL SURVEILLANCE:

Not Applicable

SIGNIFICANT WORK ACTIVITIES:

Not Applicable