Senior Clinical Research Associate
Pharmacyclics, Inc. - Switzerland, FL

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Responsible for implementing set-up, execution , oversight and reporting of Pharmacyclics clinical studies conducted globally.

Key Accountabilities/Core Job Responsibilities:
  • Support multifunctional team through clinical studies activities that meet ICH/GCP, protocol and SOP requirements
  • Develop and review local/regional clinical trial documents (e.g. training documents, translations, amendments and informed consent documents)
  • Prepare regulatory documents and submissions
  • Execute project specific training for internal and external staff
  • Verify Trial Master File maintained at CROs
  • Manage Investigational Product (IP) and support drug depots
  • 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 (e.g. central labs, imaging, IXRS, Drug Depots,)
  • 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
  • Support development of clinical study reports
  • Identify and escalate issues appropriately
  • Participate in clinical team(s), including attending required meetings and appropriately representing functional area
  • Partners with team members and other functional areas within Pharmacyclics such as Regulatory, QA, Legal, Biometrics

Qualifications:
  • Fluent English
  • Excellent verbal and written communication skills
  • Attention to detail
  • Able to organize, manage and set priorities for multiple tasks
  • Experience with multinational trials
  • Strong leadership skills, self-motivated, adaptable to a dynamic fast-paced environment
  • Able to collaborate effectively with the study team, cross-functional team members, and external partners
  • Working knowledge of ICH/GCP and FDA regulations
  • Proficiency in MS Word, Excel and PowerPoint
  • Flexibility necessary for travelling and working hours/working schedule
  • Able and willing to travel approximately 25-30%

Experience:

· Experience in a CRO, pharmaceutical, or biotechnology company (including on-site monitoring experience)

· Experience in oncology preferred

· Experience with Electronic Data Capture and IXRS systems preferred

Education Requirements:
  • BS/BA degree in a life science, nursing, or related field

Pharmacyclics, Inc. - 4 months ago - save job - copy to clipboard