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

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

Roche Sequencing
Job Location
5945 Optical Court
San Jose, CA 95138

Competitive salary and generous benefits 

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.
  • 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 
How to Apply

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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. 

Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

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