Clinical Research Associate II

San Carlos  ‐ Onsite
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Keywords

Description

The candidate, working closely with his/her Clinical Project Manager, will have overall responsibilities for managing the full scope of clinical trials (protocol development to final report, regulatory filing and/or publications) and coordinating cross functional efforts in order to achieve study objectives and corporate goals.

Responsibilities:
  • Assists with managing defined aspects of clinical trials to ensure trials are completed on time, within budget and in compliance with SOPs, FDA regulations, and ICH/GCP guidelines.
  • Perform the activities associated with the implementation and monitoring of clinical trials.
  • May participate in site monitoring and/or co-monitoring activities, as needed.
  • Experience creating and/or reviewing monitoring reports and monitoring visit letters is required.
  • Reviews and critiques electronic CRFs for accuracy and completeness. Oversees data discrepancy management and retraining as needed.
  • Provides or assists with training internal and external CRAs, CRO team members, and investigative site staff.
  • Ensures that supportive study documents are completed (e.g., scopes of work, work orders, IXRS specification documents, specific IXRS scripts, non-clinical supply materials).
  • Review and track study Trial Master Files (TMF) and submit documents to central records for storage.
  • Perform on-going review of the TMF to ensure files are properly maintained and up to date, archived and stored.
  • Maintain and enter clinical study details into Clinical Trial Management System (CTMS).
  • Responsibility for creating and maintaining documents, tables, databases, spreadsheets and files as needed.
  • Attend meetings, take and distribute meeting minutes.


Requirements:
  • Proficiency with word processing, spreadsheet, database, and presentation software (MSOffice skills such as Outlook, Word, Excel, PowerPoint) and with filing systems.
  • Computer skills should be relevant to job roles and tasks required.
  • Global trial and CRO management experience is preferred.
  • 2-5 years industry experience in drug development, including prior on-site monitoring experience.
  • Phase II/III Oncology experience preferred but not required.
  • Applicants must be based in the SF Bay Area; this is an on-site position


Education:

BS/BA in Life Science or related discipline.
Start date
06/2014
From
Real Staffing
Published at
11.06.2014
Project ID:
723928
Contract type
Permanent
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