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Thursday, July 7, 2016

Vacancy of clinical research associate

Clinical Research Associate
1-3 yrs. Bengaluru/Bangalore...
Job Description
Working in accordance with ICH E6 principles and with applicable SOPs (either ECRON AcuNova or Sponsor's SOPs) & local regulatory norms
Review of study synopsis
Site selection
Preparation of Site feasibility questionnaire, conducting the feasibility and reporting to PM
Preparation, conduct and reporting of site selection visits
Negotiation & obtaining Investigator agreement on site budget, payment to the sites
Development/Local adaptation of study specific documents (ICF, CRF prints, Study logs), translations of the documents
Procuring essential documents from sites, their QC and filing in a timely manner and updating project tracker or sending the documents to PA for filing in a timely manner
Maintenance of TMF and Site specific file
Scanning & uploading documents into shared drive
Transmission of documentation into project files
Preparation of regulatory dossier, regulatory submission and follow-up.
Preparation of EC dossier, EC submissions and follow-up
Co-ordinating arrangements for the investigators meeting, acting as a host for this meeting
Development of meeting materials along with required presentations for investigators meeting.
Site initiation visit planning, preparation, conduct, report and follow-up of pending issues
Co-ordinating the IP request between sites and pharmacist/vendor/sponsor
Site monitoring visit planning, preparation, conduct, report and follow-up of pending issues
Remote Monitoring, Central Monitoring and Risk Based Monitoring related activties
Accompanied visit as a part of mentoring a new CRA
Interacting with DM for data transfer and query resolution
Interacting with MW for CSR appendices
Preparation of project status report.
Preparations, participation in meetings and documention of meeting minutes
Provide oversight to project (maintaining quality & timelines of deliverables)
Participate in client QA assessments
Reconcilliation Filing of project correspondence
Site close-out visit planning, preparation, conduct, report.
Maintenance of Investigator database and a QC of the database
Archival of study documentationParticipation in other department inititatives/activities.
Industry :  Pharma / Biotech / Clinical Research
Functional Area :  Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology
Role :  Clinical Research Associate/Scientist
Keyskills :  Site Feasibility, Site Initiation, Clinical Research, CRA, CRF, Site Selection, ICF, Site Monitoring, Query Resolution



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