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Clinical Records Representative
4 months ago
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 fast-paced environment
- Ability to interact professionally with all team organizational levels
- Must be able to work in a team environment, including inter-departmental teams
- Ability to Provide feedback in a professional, direct, and tactful manner
**Education and Experience**:
- H.S. Diploma or equivalent Required
- 2-4 years of experience
**Job Type**: Contract
Pay: $25.00 - $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 92602 (required)
Work Location: In person
