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Minority Executive Search
P.O. Box 18063
Cleveland,

Phone: (216) 932-2022
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Company Profile




Sr. Clinical Research Associate


Job ID: 49162
Job Views: 19624
Location: Santa Clara, California, United States
Zip Code: 44118
Job Category: Biotech, Management, Pharmaceutical, Research, Science
Employment Type: Full time
Salary: $150,000.00 per year
Posted: 03.16.2015

Occupations

Biotech-R&D-Science: Biological-Chemical Research, Clinical Research, Environmental-Geological Testing & Analysis, General-Other: R&D-Science, Materials-Physical Research, Mathematical-Statistical Research, New Product R&D, Pharmaceutical Research

Job Description

Responsible for implementing set-up, execution, oversight and reporting of clinical studies while ensuring that the conduct of the trial is in compliance with the protocol, ICH/GCP, and applicable regulatory requirements.

Key Accountabilities/Core Job Responsibilities

  • Lead multifunctional team through clinical studies activities that meet ICH/GCP and SOP requirements
  • Develop clinical trial protocol synopsis, protocols, amendments and informed consent documents
  • Develop study budget and timelines
  • Prepare regulatory documents and submissions
  • Execute project specific training for internal and external staff
  • Maintain Trial Master File
  • Manage Investigational Product (IP)
  • Manage safety reporting
  • Procure and manage contracts with CROs, study vendors and investigative sites
  • Provide oversight of CROs, independent field monitors and other clinical vendors
  • Review monitoring trip reports and track resolution of all action items
  • Co-monitor at investigative sites to evaluate study site and field monitor performance
  • Collaborate with medical experts, clinical study sites, and clinical study vendors
  • Performs in-house review of clinical database listings for completeness and accuracy
  • Develops clinical study reports

Qualifications

  • Excellent verbal and written communication skills
  • Attention to detail
  • Able to organize, manage and set priorities for multiple tasks
  • Strong leadership skills, self-motivated, adaptable to a dynamic environment
  • Able to collaborate effectively with the study team, cross-functional team members, and external partners
  • Knowledge of ICH/GCP and FDA regulations
  • Proficiency in MS Word, Excel and Powerpoint
  • Able and willing to travel approximately 25-30%

 


Job Requirements

Experience

  • 6+ years of relevant clinical experience in a CRO, pharmaceutical, or biotechnology company (including on-site monitoring experience)
  • Experience in Oncology or Hematology preferred
  • Experience in global trials preferred
  • Experience with Electronic Data Capture systems preferred

Education Requirements

  • BS/BA degree in a life science, RN, or related field

 



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