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Documentation Specialist
•30 days ago
| Hours | Full-time, Part-time |
|---|---|
| Location | Stamford, CT Stamford, Connecticut |
About this job
Our client is looking for a CTA to join their team.
Job Summary:
The candidate is responsible for the filing and management of the essential documents for a Clinical Trial in the Trial Master File (TMF). The individual will also be responsible for the transition and retrieval of files in long term storage archive.
Job Responsibilities:
- eTMF Migration
- Overview of Clinical Document Coordinators
- Filing the essential clinical documents and maintenance of the TMF.
- Tracks and performs quality control of incoming paper essential documents to the TMF
- Ensures the TMF file room security rules per the TMF SOP and working practices
- Prepares and transitions study documents to long-term archiving facility.
- Maintains archival records
- Retrieves study documents from long term facilities when requested.
- May include administrative duties of photocopying, scanning, paper file set-up, etc
Technical Skills:
- Familiar with the ICH E6 Good Clinical Practices
- Good interpersonal skills
- Demonstrates attention to detail
- Efficient in MS word and excel
About Aerotek Clinical:
Join Aerotek Clinical, a division of Aerotek Scientific® LLC, one of the fastest growing providers of scientific and clinical services in the country. Due to our growth, we’re constantly on the lookout for qualified professionals to place in contract, contract-to-hire, and permanent placement positions across a number of different industries. We know it’s more than just your day-to-day responsibilities that can make or break a job. It's the support you get. That's the reason Aerotek offers a variety of benefits including medical, dental, optical, 401k, and many more. Don't put your career in the hands of just anyone, put it in the hands of a specialist. Join the Aerotek team! Allegis Group and its subsidiaries are equal opportunity employers and will consider all applications without regard to race, marital status, sex, age, color, religion, national origin, veteran status, disability or any other characteristic protected by law.
Job Summary:
The candidate is responsible for the filing and management of the essential documents for a Clinical Trial in the Trial Master File (TMF). The individual will also be responsible for the transition and retrieval of files in long term storage archive.
Job Responsibilities:
- eTMF Migration
- Overview of Clinical Document Coordinators
- Filing the essential clinical documents and maintenance of the TMF.
- Tracks and performs quality control of incoming paper essential documents to the TMF
- Ensures the TMF file room security rules per the TMF SOP and working practices
- Prepares and transitions study documents to long-term archiving facility.
- Maintains archival records
- Retrieves study documents from long term facilities when requested.
- May include administrative duties of photocopying, scanning, paper file set-up, etc
Technical Skills:
- Familiar with the ICH E6 Good Clinical Practices
- Good interpersonal skills
- Demonstrates attention to detail
- Efficient in MS word and excel
About Aerotek Clinical:
Join Aerotek Clinical, a division of Aerotek Scientific® LLC, one of the fastest growing providers of scientific and clinical services in the country. Due to our growth, we’re constantly on the lookout for qualified professionals to place in contract, contract-to-hire, and permanent placement positions across a number of different industries. We know it’s more than just your day-to-day responsibilities that can make or break a job. It's the support you get. That's the reason Aerotek offers a variety of benefits including medical, dental, optical, 401k, and many more. Don't put your career in the hands of just anyone, put it in the hands of a specialist. Join the Aerotek team! Allegis Group and its subsidiaries are equal opportunity employers and will consider all applications without regard to race, marital status, sex, age, color, religion, national origin, veteran status, disability or any other characteristic protected by law.
Requirements
Documentation Sp-Uncategorized, eTMF Experience, QC, Documentum, Sharepoint, Regulatory Documents
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