Clinical Records Representative - Irvine, United States - Infosoft

Infosoft
Infosoft
Verified Company
Irvine, United States

3 weeks ago

Mark Lane

Posted by:

Mark Lane

beBee recruiter
Description
One of our clients is looking for a talented and highly motivated
Clinical Records Representative.

Please
send your resume if you would like to pursue this opportunity and you authorize Infosoft to represent you for this position.

Here are the job position details for your review:

Job Title
:
Clinical Records Representative

Pay Rate
:
$25 to $31.22/HR
Duration
:12 months

Location
:
Irvine, CA
Our Client is a
Global medical device Manufacturer.
We are looking for a
Clinical Records Representative

Summary:


The main function of a clinical records representative is to ensure the accuracy and completeness of documents for clinical studies.


Key Responsibilities:


  • Review and ensure accuracy and completeness of clinical study documents (e.g., EFS, pivotal) ensuring GDP and performing quality checks with limited supervision
  • Organize and archive documents and data in eTMF (electronic trial master file) and/or CTMS (clinical trial management system) ensuring compliance with internal procedures and regulatory guidelines
  • Support team members during internal and external audits
  • Other incidental duties: May maintain and track study supplies

Additional Skills:


  • Good computer skills including MS Office Suite, Adobe, and ability to operate general office machinery
  • Good written and verbal communication skills and interpersonal relationship skills
  • Basic knowledge and understanding of our policies and procedures relevant to clinical study documentation
  • Basic knowledge of EW GDP (Good Document Practice) SOP requirements
  • Ability to manage confidential information with discretion
  • Strict attention to detail
  • Ability to manage competing priorities in a fastpaced environment
  • Ability to interact professionally with all team organizational levels
  • Must be able to work in a team environment, including interdepartmental teams
  • Ability to Provide feedback in a professional, direct, and tactful manner

Education and Experience:


  • H.S. Diploma or equivalent Required
  • 24 years of experience

Job Type:
Contract


Pay:
$ $31.00 per hour


Schedule:

  • 8 hour shift

Application Question(s):

  • This is a W2 position. Are you ok to work on W2?

Education:


  • High school or equivalent (required)

Experience:


  • Clinical study documentation: 2 years (required)
- clinical trails: 1 year (required)
- eTMF/


CTMS:
2 years (required)


Ability to Commute:

  • Irvine, CA required)

Work Location:
In person
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