Job Title: Regulatory Operations Assistant
Location: Foster City, CA
Employment Type: Contract
Company Overview:
Integrated Resources, Inc. (IRI) is a workforce solutions provider, delivering strategic services to efficiently manage talent and business operations. Established in 1996, IRI has built a strong team of experts, expanding into new sectors and achieving steady growth over the years.
Position Summary:
The Regulatory Operations Assistant will be involved in the clinical trial disclosure and transparency function. The role primarily supports the Disclosure & Transparency team in clinical trial registrations, results postings, and the extraction and redaction of clinical documents in line with EMA Policy 0070.
Key Responsibilities:
Clinical Trial Registration: Assist with the registration of new clinical trials on ClinicalTrials.gov and the EU Clinical Trial Register (EudraCT).
Results Posting: Support the posting of clinical trial results and relevant updates in EudraCT.
Policy 0070:
Collect and organize required documents.
Assist in the extraction and preparation of documents for Policy 0070.
Perform auto-redaction and manual redaction of clinical documents.
Facilitate the review process and publication of redacted documents.
Prepare other Policy 0070 materials, including Justification Tables, Anonymization Reports, and Document Inventories.
Document Management: Perform quality control and editing reviews of clinical and regulatory documents such as CSRs, IBs, CTDs.
Team Participation: Attend routine group meetings and, under guidance, participate in cross-functional meetings.
Qualifications and Skills:
Education: Bachelor’s degree in a relevant field.
Experience: At least 2 years of relevant experience in clinical research or regulatory operations, preferably in Clinical R&D (Clinical Operations).
Knowledge:
Basic understanding of Clinical Development and associated regulations (FDA, EMA).
Familiarity with industry best practices (ICH, GCP).
Skills:
Strong organizational skills with the ability to manage multiple projects.
High attention to detail and ability to work under tight deadlines.
Excellent verbal and written communication skills.
Ability to work well in team settings and communicate effectively with various stakeholders.
Gujarat :
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Siliguri |Illinois :
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Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Koropi | Athens |Greece :
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Auckland |New Zealand :
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