Company: Zuventus Healthcare Ltd
Post: Clinical Research Associate
Experience: 0-5yrs
Qualification: B.Pharm/M.Pharm
Location: Mumbai
Job Description:
- Establish and maintain the tracking tools for assigned trials.
- Create, assemble and coordinate shipping of study materials.
- Conduct initial review and tracking of invoices & study payments.
- Receive clinical study documents from study team, review for completion, accuracy & expiration, and filling the same in study file.
- Preparation of dossier for EC submission and sending the required documents to the sites.
- Prepare the study files (TMF, SMF and ISF) and sending the ISF to the respective sites along with the all required documents.
- Review TMF and SMF inventory for missing and expiring documents on an ongoing basis as per study requirements.
- Support maintenance of the Trial Master File (TMF) & Site Master File (SMF) and assist in quality control as appropriate.
- Support Clinical Trial manager and CRA to track and file documents and study metrics.
- Assist CRAs in preparation for clinical trial site monitoring visits.
- Assist in the creation of study materials, including but not limited to documents, presentations, and reports.
- Updating all the study trackers for updates in timely manners and provide any data as per requirement.
- Perform in house follow-up of issues and get resolved in timely manner.
- Reconciliation and Management of IP and other clinical trial supplies.
- Update controlled documents and SOPs as required.
- Pharmacovigilance related activities- Clinical Report writing-Product appraisals-Scientific article search and collation of documents-Regulatory documents compilation from medical point of view
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