Position: Inhouse Clinical Research Associate
Location: Charleston, SC, United States
Job Category: Clinical Research
Role Overview:
The Inhouse CRA will provide support to the Clinical Research Associates (CRAs) with various in-house activities on assigned clinical trial projects. This includes document management, coordination of trial materials, and support for monitoring visits.
Key Responsibilities:
As an Inhouse CRA, your tasks will include:
Maintain Trial Master Files (TMF): Track documents, prepare for audits, conduct routine QC reviews, and ensure final reconciliation according to ICH GCP and SOPs.
Essential Document Management: Assist with development, collection, and management of essential documents, including translations when needed.
Regulatory Submissions: Collaborate with the Regulatory Start-Up team to manage ethics and regulatory submission documents and assist with Import/Export applications.
Clinical Trial Management System (CTMS): Assist with maintaining site compliance, entering site milestones, and ensuring data accuracy.
Materials Management: Create Investigator Site Files and coordinate trial materials’ ordering, dispatch, and tracking.
Monitoring Visit Support: Assist CRAs with preparation for onsite/remote visits and ensure follow-up actions are addressed.
Qualifications & Experience:
The ideal candidate will have:
Relevant experience or qualifications in Life Sciences or a related field (administrative experience can also be considered).
Experience in the pharmaceutical, CRO, or healthcare industry is advantageous.
About Novotech:
Novotech is a global full-service Clinical Research Organization (CRO) providing clinical development services across all clinical trial phases and therapeutic areas. They have expertise in Phase I to IV clinical trials and bioequivalence studies. With offices across Asia-Pacific, North America, and Europe, Novotech employs over 3,000 people and collaborates with over 5,000 sites.
Application Details:
Location: 22 Westedge Drive, Suite 500, Charleston, SC 29403, US
Job Schedule: Full-Time
Posting Date: January 31, 2025
To apply, click Apply Now and complete the application process.
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