CLINICAL DATA COORDINATOR II

Integrium designs and manages clinical trials from Phase II to Phase IV - ranging from small proof of concept studies to pivotal Phase III studies to large-scale Phase IV community-based trials. At Integrium, we combine cutting-edge science and practical operational management to bring innovative ideas to all aspects of work scope development and the marketplace. We provide highly ethical and honest service with approachable, accountable, capable and committed professionals.

 

We are seeking a PROJECT CLINICAL DATA COORDINATOR

 

The Project Clinical Data Coordinator will perform the day to day tasks associated with cleaning a clinical database.  Reviews electronic discrepancies and issues queries.  Updates the database based on query responses, as well as Self Evident Corrections.  Performs manual checks on Case Report Forms pages.  Performs listing review and Quality Control activities.  Assists with the development and testing of data entry screens and edit checks, and development of Case Report Forms.  Responsible for Data Clarification Form tracking and daily reports.  Will also assist in setting up and closing clinical databases, as well as developing and maintaining study documentation

 

Principal Responsibilities:Assist with developing and testing data entry screens and edit checks, CRF tracking, DCF tracking and other day to day reports and tools.Assist with maintaining project specific data management documentation.Responsible to attend all internal meetings involving assigned projects.Assist in the data clarification process by producing automated and manual queries, tracking outstanding DCF?s, and assisting with correction and completion of returned DCF?s.Assist with database closure activities.Review data listings for any further DCF?s.  In addition, review data listings to ensure data quality.Assist with the specification for setting up database for assigned projects.Assist in the development and maintenance of the Data Management study documentation.Perform day to day Data Management related functions in conjunction with the project teams.Assist with all close-out activities associated with a clinical study.Strict adherence to Company and/or Sponsor SOPs and Corporate Policies.Up to 10% travel required.

 

Educations/Skills Requirements:Bachelor?s Degree or higher preferably in a health, medical or other life science field or equivalent experience.Minimum of 2+ year?s background in a CRO/Pharmaceuticals/Biotech industry ? Data Management environment.Excellent written and verbal communication skills.Ability to manage multiple tasks with strong organizational skills.Ability to work in a multi-disciplinary team setting.Careful attention to detail and accuracy.Proficient in Microsoft Office software packages, including a strong knowledge of Excel, as well as data/account software programsKnowledge in SQL and/or SASExperience in any Oracle based software program, i.e., Oracle Clinic, Clintrial, Inform or Data Track.

 

For immediate consideration, please forward resumes to hr@integrium.com or fax to 714-210-7079.

 

For more information on Integrium, please visit our website at www.integrium.com