Professional - US - Clinical Data Associate I - US Tech Solutions, Inc.
Rockville, MD 20850
About the Job
Position Summary:
Job Title : Clinical Data Associate
Location: Rockville MD .
Duration: 12 Months possibility of extension
The Clinical Data Associate tasks include the following as they relate to biospecimen collection in clinical trials:
Qualifications/Experience:
Required Skills Include:
Job Title : Clinical Data Associate
Location: Rockville MD .
Duration: 12 Months possibility of extension
The Clinical Data Associate tasks include the following as they relate to biospecimen collection in clinical trials:
- Assist with the development of CRFs and CRF Completion Guidelines
- Perform user acceptance/database testing to ensure the quality and integrity of the clinical study database design and associated edit check programming prior to the study database being released to collect data.
- Generate status reports and distribute to the study teams as needed.
- Follow-up with study team on outstanding items
- Conduct data review and associated query generation/resolution.
- Reconcile data from third party vendors (i.e. Lab data) with the clinical study database and communicate issues/discrepancies to the PDM.
- Maintain accurate and complete study records including filing, archiving and inventory of study documents.
- Liaise with Clinical Data Analysts for review and completion of SDTM related deliverables.
- Review data per the Data Validation Specifications and Integrated Data Review Plan
- Participate in internal/external functional meetings as required.
- Other activities as directed by PDM or Program Lead
Qualifications/Experience:
- Bachelor’s degree and of 1 to 3 years’ experience in research/pharma setting
Required Skills Include:
- Working knowledge of the pharmaceutical industry and an understanding of protocols and scientific terminology
- Basic knowledge on data standards, ICH, GCP and SDTM
- Strong computer skills with demonstrated experience in working with databases
- Ability to work in team setting as well as independently with minimal instruction
- Ability to multitask and balance several ongoing tasks
- Familiar with SAS
Source : US Tech Solutions, Inc.