Job Description
Responsible for coordinating and performing (if applicable) the collection, distribution and storage/ archival of data/ study material/ study supply generated (for assigned studies) during clinical research trials.
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nResponsible to ensure that the assigned trials stay on track with applicable regulations, GCP, Protocol and Tech Observer/ Sponsor SOP’s.
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nMaintain databases of patient information; collect information for grant proposals and write correspondence.
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nMaintain Investigator database and search recent potential Investigators for upcoming trials.
nEnter data from forms and documents into databases as required for assigned studies.
nProvide assistance to operational team by organizing files, projects, data and keeping it up to date for assigned studies.
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nMaintain Trial Master File (TMF) in coordination with APM/PM for assigned studies.
nAssist CRA for the maintenance of the Site Master File ( SMF)
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nAssist with routine in-house data verification and quality control,
ensuring data integrity and consistency with prescribed study protocol for assigned studies.
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nUse Standard Operating Procedures (SOPs) concepts, practices in a time sensitive manner.
nAssist CRA in investigator meeting preparation, liaison, presentations, and follow up for assigned studies.
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nAssist CRA in tracking the Investigator site payment and liaise with sites for follow up on open issues, recruitment status update, required documents for TMF & resolution of open queries in CRF. Ensure timely submission of protocol / consent documents for EC/IRB approval. Including follow up for the approval status from site personnel for assigned studies
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nCommunicate progress of study and relevant information to Project Manager/ CRA and other project team members as requested for assigned studies.
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nAssist CRA in archiving of study files on completion of a clinical trial.
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nMay coordinate with vendors involved in a clinical trial as requested for