Clinical Research Associate - Oncology - Fremont

Fremont  ‐ Onsite
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Keywords

Description

Job duties include but not limited to the following:
  • Plans, implements and executes FDA registration trials to support clinical claims.
  • Supports the preparation of reports and summary documents (for internal and external customers) for product registration.
  • Assists team in budget and contract negotiations with study sites, central laboratories and CROs.
  • Study start-up, monitoring and study close-out activities being performed within the team. Ensures adherence to regulations, guidelines and departmental standard operating procedures on the part of direct reports and monitors the trial budgets and timelines.
  • Plans and prepares execution of studies through all phases of the study process
  • Provides technical input to study designs and clinical development plans
  • Reviews study protocols, reports and manuscripts
  • Works with Data Management and Biometrics staff on the design of documents and processes for the collection of study data from participating sites
  • Ensures compliance with Good Clinical Practices, regulations, SOPs and protocols
  • Collects and maintains legal and regulatory documentation, as applicable
  • Ensures accurate and complete study management/data collection and transfer into the data management system
  • Ensures site compliance with regulations and study protocol
  • Acquires and maintains technical knowledge of product line


Requirements:
  • 3-5 years of CRA experience
  • IVD experience is preferred
  • Oncology clinical trial experience highly preferred
  • Laboratory/Med Tech background highly desirable
  • Bachelor's or Masters in Biology, Chemistry, Molecular Biology or related discipline.
  • Global study experience/experience managing sites located in Europe/Asia
  • Extremely detail oriented.
  • Ability to work in a team situation
  • Vendor management experience
  • Budget and contract development
  • Ability to solve problems in a detailed, comprehensive manner with demonstrated urgency and energy to handle problems.
  • Must meet timelines and manage sites.
  • Excellent written and verbal communication skills and good presentation skills are required.
  • MSWord, Excel and PowerPoint skills are required.
  • Experience developing professional presentations and presenting to investigational sites and management
  • Up to 35% travel may be needed (domestic and international).


To find out more about Real please visit www.realstaffing.com
Start date
03/2014
From
Real Staffing
Published at
15.03.2014
Project ID:
679809
Contract type
Freelance
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