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Regulatory Document Specialist Job
Eingestellt von Yoh
Gesuchte Skills: Support, Client
Projektbeschreibung
WHAT YOU'LL BE DOING:
- Support the goals of the US Global Monitoring Operations, via managing the processing of regulatory documents in electronic and hard-copy median; with strict adherence to ICH, GCP and FDA regulations.
- Perform periodic regulatory document QC and reconciliation activities, to ensure inspection readiness and regulatory compliance.
- Liaise with Field Monitors (CRA) to administer the regulatory document management life cycle of eTMF maintenance documents.
- Track, ensure quality, scan and upload of these documents within eTMF/CREDI.
- Perform monthly reconciliations of Principal Investigator changes to ensure compliance with CQA and FDA IND requirements.
- Provide provisional support to other regulatory documentation specialists within the scope of processing, disseminating and tracking VDR/core regulatory and other eTMF maintenance documents.
- Manage the back-fill of Legacy hard-copy documents, which are needed to complete the eTMF file in CREDI, in conjunction with the Document Management group (mDoc).
- Perform periodic QC of CREDI, to ensure document quality (legibility, naming conventions etc.) standards are maintained for eTMF documents.
- Assist in maintaining eTMF trackers as a mechanism for ensuring that FDA inspection readiness.
- Validate site participation and patient commitment via Rapid Document Deployment process.
- Process final Contracts/Schedule-A files in conjunction with Contract Management team.
WHAT YOU NEED TO BRING TO THE TABLE:
- Associate's Degree, with at least one year experience in clinical research including a working knowledge of clinical/regulatory development process; study start-up experience preferred.
- Fluent English (oral and written)
- Good understanding of TMF document types and ability to distinguish and segment these documents
- Substantial knowledge of ICH, GCP and FDA regulations
- Prior experience with electronic document management systems plus scanning and imaging experience Proven ability to work unilaterally or within teams and deliver on commitments.
- Proficient in Microsoft Office and the use of general office equipment Strong oral and written communication skills.
- Ability to multi-task and prioritize multiple high-priority projects
- Detail oriented with superior organization and documentation skills
OPPORTUNITY IS CALLING, APPLY NOW!
RECRUITER: Krista Leach
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.
J2W: CLINICAL
CON_W2
MONJOB
J2WMIDATL
Ref:
SFSF: LS
Projektdetails
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Einsatzort:
East Hanover, Vereinigte Staaten
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Projektbeginn:
asap
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Projektdauer:
Keine Angabe
- Vertragsart:
-
Berufserfahrung:
Keine Angabe
Geforderte Qualifikationen
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Kategorie:
IT Entwicklung, Sonstiges