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Study Management Associate
Ref No.: 18-00679
Location: Irvine, California
Position Type:Contract
Start Date / End Date: 06/04/2018 to 06/03/2019
STUDY MANAGEMENT ASSOCIATE
IRVINE, CA


Project Description:
The Study Management Associate (also known as Clinical Trial Management Associate) assists the Sr. Clinical Trial Management Associate, Clinical Trial Manager (CTM) or Operations Study Lead (OSL) in the operational execution of assigned clinical studies.
  • In this role the associate will perform tasks as assigned by their manager which includes but is not limited to preparing, collecting, and tracking master study level documents and site non-regulatory documents, reviewing, updating, and testing clinical systems, producing reports on clinical status, trends, and metrics, facilitating communication across Client departments, supporting the monitoring team and study sites with relevant study information, and supporting clinical operations.
  • The incumbent ensures the assigned clinical study is run to time and budget and is completed in compliance with all relevant laws, regulations, and regulatory guidelines as well as all Client policies and procedures.

Required Skills:
In addition to the essential skills, the following abilities are required:
  • Handle and prioritize multiple tasks simultaneously.
  • Work effectively in a team/matrix environment.
  • Understand technical, scientific and medical information.
  • Handle conflict management and resolution.
  • Understand clinical study budgets.
  • Plan, organize, project manage and analyze data.
  • Demonstrate full competency in Microsoft Office programs.
  • A good understanding of the following is also required:
    • Good Clinical Practices, ICH guidelines, PhRMA code, CFR Guidelines, clinical research ethics, HIPAA and patient privacy laws (plus applicable local regulations, when country-based).
  • Knowledge of concepts of clinical research and drug development.

This 12+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Bridget: bridget@alphaconsulting.com

ALPHA'S REQUIREMENT #18-00679
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE