Job description
LeadStack Inc. is an award-winning, one of the nation’s fastest-growing, certified minority-owned (MBE) staffing services provider of contingent workforce. As a recognized industry leader in contingent workforce solutions and Certified as a Great Place to Work, we’re proud to partner with some of the most admired Fortune 500 brands in the world.
Job Title: Clinical Records Associate – II
Duration: 18 Months
Locations: Remote
Key skills: TMF, records management, GCP, Clinical Regulations, Understanding of clinical contracts and procurement process, process management, project management
Systems: Veeva eTMF, Apttus, GDAR, SharePoint, word, PowerPoint, excel, adobe acrobat
General Position Summary / Purpose:
- The Clinical Records Associate II in the Clinical Records Team will support 2 key activities: 1. Mergers, Acquisitions, Divestitures & Out-licensing 2. Clinical contract processing, management, and archiving. As a member of the Clinical Records team, the Associate will collaborate cross functionally across, Clinical Operations and Development Business Operations functional groups in the planning, development, and implementation of standards, processes, and projects for the TMF (Trial Master File) and Clinical Agreements/contracts.
- The successful candidate will be responsible for ensuring effective and efficient archiving of the TMF, clinical agreements and associated records as well as complying with relevant regulatory, legal, country specific and corporate requirements to produce and maintain inspection readiness for clinical records.
Top 3 Required Skill Sets:
1. Records Management (Document filing both paper documents and electronic)
2. Clinical Contract processing and related system (Apptus)
3. Clinical Trial Masterfile (TMF) management and related systems (Veeva Vault eTMF, Document Management Systems)
To know more about current opportunities at LeadStack, please visit us at https://leadstackinc.com/careers/
Should you have any questions, feel free to call me on (425)400-1050 or email at sahil.sharma@leadstackinc.com
Job Type: Contract
Salary: $45.00 - $55.00 per hour
Schedule:
- 8 hour shift
Work Location: Remote
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