Principal Clinical Research Associate, Sequencing

Organization
Roche Sequencing
Job Location
5945 Optical Court
San Jose, CA 95138
Job Description
  • 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. Independantly 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 organizaiton.
  • Plans owns work assignments; may plan and/or delegate work to others.
  • Assumes responsiblity 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, RMS 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 transferto 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 RMD departments or Roche companies on significant matters often requiring coordinatoin between departments/organziations.
  • May lead project teams to solve business problems of moderate size risk and complexity.
  • Assists investigators with publication activities.
Requirements
  • Bachelors 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 
About Our Organization

As pioneers in sequencing with a rich heritage in diagnostics, Roche's Sequencing Unit is committed to a future that fosters innovation to provide solutions that enable scientific discovery and deliver clinical value – We are Changing Science and Changing Lives.

At Roche, 91,700 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity. 

 

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