Principal Clinical Research Associate, NIPT/Women's Health, Sequencing 

Location: San Jose, CA
Date Posted: 11-07-2016
Job Functions
  • Provides leadership in complex clinical research activities including: reaching agreement on study goals with other functional areas, coordinating and overseeing study monitors and investigators to ensure compliance, monitoring, analyzing and interpreting study data, and preparing reports.
  • May contribute to the design of clinical studies. Independently plans and implements complex or significant clinical research studies and projects.
  • Ensures that goals and activities of own work or project team is aligned with the objectives of the area(s) and the organization.
  • Plans own work assignments; may plan and/or delegate work to others.
  • Assumes responsibility for coordinating the activities of relevant colleagues within the Company and investigators to ensure compliance with the overall scientific objectives.
  • Maintains a high level of professional expertise through familiarity with scientific literature, the Company product portfolio and competitive environment.
  • Travels to field sites to monitor studies or coach and train co-workers at the CRA level and below.
  • Reviews study protocols, reports and manuscripts. Contribute technical and clinical operations expertise for these documents
  • Works with Data Management and Biostatistical staff on the design of documents and processes for the collection of study data from participating sites.
  • May recruit, train, and manage co-workers and contract workers for specific projects
  • Collects and maintains legal and regulatory documentation, as applicable.
  • Ensures accurate and complete study management/data collection and transfer to data management.
  • Ensures site compliance with regulations and study protocol.
  • Manages material logistics for the studies
  • Coordinates or conducts reference material testing in-house
  • Organizes investigators meetings, as necessary
  • May represent the Company as primary contact on projects.
  •  Interacts with senior management from other departments or affiliate companies on significant matters often requiring coordination between departments/organizations.
  • May lead project teams to solve business problems of moderate size risk and complexity.
  • Assists investigators with publication activities.
  • Bachelor’s degree in a scientific discipline or related field
  • Preferred MS or PhD
  • 7+ years relevant work experience with 5+years Clinical Research Associate experience
  • Preferred 8-10+ years relevant experience 
Very competitive salary and benefits!
Great company to work for!
Full relocation package is available!
Don't miss out! Apply now and we'll be in touch immediately with more specific details, salary information and to answer any questions!!

This position does NOT provide sponsorship so please do NOT apply if you require sponsorship.  Thank You

KP Recruiting Group 
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