Zuventus Healthcare Ltd. hiring B.Pharm/M.Pharm 0-5 years experience in Medical writing or clinical research ||4-8 lac per annum
Apply for the position of Clinical Research Assistant/Associate
Location: Mumbai
Experience 0-5 years in Medical writing or clinical research
Salary: Rs. 4-8 lac per annum
Qualification: B-Pharm/M-Pharm
Please send your CV to [email protected]
-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.
-Review and assist in the collection of essential documents for completeness and compliance with the protocol and appropriate regulations.
-Distribute clinical trial related materials to sites or clinical trial team members.
-May act as a central contact for designated project communications, correspondence and associated documentation.
-Participate in team meetings and assist in tracking of action items.
-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.
-Perform administrative tasks to support Clinical Trial Department and team members as needed.
-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
Please send your CV to [email protected]
