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Clinical Research Associate II
Ref No.: 18-22411
Location: Milpitas, California
Start Date: 04/03/2018
Job Title: Clinical Research Associate II
Major Functional Area(s): Medical and Scientific Affairs
Reports to (position): Manager, Clinical Operations or higher
Section 1: Essential Job Functions & Major Contributions
  1. Works under general supervision, and participates in the design, planning, implementation and overall direction of clinical research projects; May co-ordinate the activities of relevant colleagues within the Company and investigators to ensure compliance with the overall scientific study objectives. May work with international investigators and key customers as well.
  2. Travels to field sites to monitor studies.
  3. Receives general instructions; plans and prepares studies.
  4. Reviews study protocols, reports and manuscripts. Contribute technical and clinical operations expertise for these documents
  5. Works with Data Management and Biostatistics staff on the design of documents and processes for the collection of study data from participating sites.
  6. Collects and maintains legal and regulatory documentation, as applicable.
  7. Assumes responsibility for training and coordinating certification of study site personnel.
  8. Ensures accurate and complete study management/data collection and transfer to data management
  9. Ensures site compliance with regulations and study protocol.
  10. Monitors the sites and provides technical assistance, as necessary.
  11. Assists, prepares and manages study timelines
  12. Manages material logistics for the studies.
  13. Conducts reference material testing in-house.
  14. Organizes investigator meetings, as necessary.
  15. Participates in Project Team Meetings.
  16. Keeps informed of trends and developments in clinical research.
  17. Knows and effectively uses the broad concepts of a particular field or speicalization to resolve problems of limited scope and complexity.
  18. Analyzes alternative approaches to solve problems or devleop new perspectives n existing solutons.