Ref No.: 17-00031
Location: Pleasanton, California
CRA

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.
  1. Travels to field sites to monitor studies.
  2. Receives general instructions; plans and prepares studies.
  3. Reviews study protocols, reports and manuscripts. Contribute technical and clinical operations expertise for these documents
  4. Works with Data Management and Biostatistics staff on the design of documents and processes for the collection of study data from participating sites.
  5. Collects and maintains legal and regulatory documentation, as applicable.
  6. Assumes responsibility for training and coordinating certification of study site personnel.
  7. Ensures accurate and complete study management/data collection and transfer to data management
  8. Ensures site compliance with regulations and study protocol.
  9. Monitors the sites and provides technical assistance, as necessary.
  10. Assists, prepares and manages study timelines
  11. Manages material logistics for the studies.
  12. Conducts reference material testing in-house.
  13. Organizes investigator meetings, as necessary.
  14. Participates in Project Team Meetings.
  15. Keeps informed of trends and developments in clinical research.
  16. Knows and effectively uses the broad concepts of a particular field or speicalization to resolve problems of limited scope and complexity.
  17. Analyzes alternative approaches to solve problems or devleop new perspectives n existing solutons.
Education:
Bachelors degree in a scientific discipline or related field, or equivalent combination of education and work experience. MS preferred.
Experience:
Minimum required: 2-4 years of relevant clinical research experience.
Preferred: 4-6 years of relevant clinical research experience


Sr. CRA
  1. Works under moderate guidance and participates in the planning and implementation clinical research projects; contributes technical and clinical operations expertise
  2. 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.
  3. Travels to field sites to monitor studies.
  4. Under moderate guidance; plans and prepares studies.
  5. Reviews study protocols, reports and manuscripts. Contribute technical and clinical operations expertise for these documents
  6. Works with Data Management and Biostatistics staff on the design of documents and processes for the collection of study data from participating sites.
  7. Collects and maintains legal and regulatory documentation, as applicable.
  8. Manages training and coordinating certification of study site personnel.
  9. Ensures accurate and complete study management/data collection and transfer to data management.
  10. Ensures site compliance with regulations and study protocol.
  11. Monitors the sites and provides technical assistance, as necessary.
  12. Manages material logistics for the studies.
  13. Conducts reference material testing in-house.
  14. Organizes investigator meetings, as necessary.
  15. May act as a lead for assigned projects and/or Project Team Meetings.
  16. Evaluates and escalates decisions impacting project team and/or work area(s) and/or broader organization.
  17. Maintains a high level of professional expertise through familiarity with scientific literature, Company product portfolio, and competitive environments.
  18. Processes and applies specific knowledge to the completion of difficult work assignments
Education:
Bachelor's degree in a scientific discipline or related field. MS or PhD preferred.
Experience:
Typically requires 5+ years of related CRA experience.
Preferred 5+ years of related CRA experience