Job Description :
- Maintain required records of study activity including case report forms, drug dispensation records, or regulatory forms.
- Oversee subject enrollment to ensure that informed consent is properly obtained and documented. Monitor study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional polices.
- Record adverse event and side effect data and confer with investigators regarding the reporting of events to oversight agencies.
- Prepare study-related documentation such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, and progress reports.
- Manage the processes of subject recruitment, appointment scheduling, informed consent, subject visits, source document preparation, Case Report Form and other document preparation and disposition, and regulatory documentation and reporting.
- Track enrollment status of subjects and document dropout information such as dropout causes and subject contact efforts.
- Review proposed study protocols to evaluate factors such as sample collection processes, data management plans, and potential subject risks.
- Adhere to Research Standard Operating Procedures.
- Must have strong knowledge of INFORM, Medidata, RAVE, SAS, Oracle Clinical, OC/RDC, Documentum, 21CFR Part 11, MedDRA, LIMS, MS Visio and MS Project.
Experience Required : 1-2 years
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