Zuventus Job Vacancy For B.Pharm/ M.Pharm- Freshers/ Experienced

 Zuventus Job Vacancy For B.Pharm/ M.Pharm- Freshers/ Experienced

Zuventus Job Vacancy For B.Pharm/ M.Pharm- Freshers/ Experienced

Position: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 medico@zuventus.com

-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