Wellknown global company in industry

Your new company
Wellknown global company in industry

Your new role

What you'll need to succeed
More than 2 year CRA experience of Global project in Pharmaceutical company or CRO, and have the experience of Global Study (Phase II or III Study) for more than 1 year
Have monitoring experience Site Initiation and Interim Monitoring Visit

What you'll get in return
Review and/or input to study protocol, CRF, CRF Completion Guideline, Informed Consent Form and validation tools etc.
• Conduct/Assists in the submission to the Institutional Review Board (central and local) and to Competent / Regulatory Authorities
• Assists in developing of Investigator and Institution contracts, negotiates budgets and arranges site payments
• Participates to/Conducts Investigators selection/feasibility: e.g. phone contacts, questionnaire
• Conduct site qualification visits (pre-study visits)
• Conduct site initiation- and site close out visits
• Conduct regular monitoring visits: check of accuracy of study procedures, source data/document verification to ensure protocol compliance and that the clinical data are complete, logical and accurate, check consistency within CRFs, perform translation, collection of CRFs, follow-up of SAE, visit the pharmacy or designated Investigator facility (if applicable) to ensure that the Investigational Product(IP) has been adequately delivered, checks that there is an adequate stock, perform IP accountability control, checks that the storage conditions are eligible, that the storage temperature control is adequately documented and ensures the IP destruction or return
• Ensures that the site is equipped with all necessary supplies for timely reporting and that the procedures (sampling storage and shipment logistics) are appropriately adhered to
• Writes a monitoring report after each type of visit, in which the tasks performed during the visit and any problems encountered are reported, along with follow-up on any outstanding issues.
• Tracking of documents in CTMS
• Responsible for the quality of data from his/her own sites
• Resolves questions/issues with investigator/trial staff including query verification
• Manages his/her own visit schedule, appointments and the follow-up of issues between visits under, along with regular communication with the sites and the clinical study team

What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career. #1225081


Job Type
Life Sciences

Talk to a consultant

Talk to Gioia Wang, the specialist consultant managing this position, located in Shanghai
Unit 1205-1212, HKRI Centre One, HKRI Taikoo Hui, 288 Shimen Road (No.1)

Telephone: 2123229656