Senior Clinical Research Associate
About the company Global clinical research organisation with a closely knit team and a supportive management to cater the growth and development of its employees. About the opportunity The SCRA will be based at the Sponsors office working exclusively on their studies. Majority of the studies are in Oncology.
The SCRA will take on additional responsibilities that include additional tasks associated with Lead CRA, Senior CRA, Local Study Team Leader (LSTL). Responsibilities Initiate, monitor and close study sites in compliance with SOPs. Share information on patient recruitment and study site progress within local Study Delivery Team.
Drive performance at the sites. Proactively identify study-related issues and escalates as appropriate. Ensure completeness of the Study Master File and ensure essential documents are sent to R&D site.
Ensure data query resolution. Ensure timely delivery of proper applications/documents for submission to Regulatory Authorities. Ensure timely customization and completion of the CSA for designated studies Design draft budget for designated studies according to study requirements Track and manage agreed payments at study site level.
Participate in training and mentoring of new members of the local Study Delivery Team ensuring compliance with ICH/GCP and Procedural documents. Ensure that all study documents are ready for final archiving and sign-off completion of local part of the Trial Master File. Contribute to process improvements, knowledge transfer and best practice sharing.
Skills and Experience 1-5 years of local clinical monitoring experience from global pharmaceutical, CRO, Bio-pharmaceutical companies. Preferably experience in monitoring Oncology trials. How to Apply Click apply or contact Christine Covero, Senior Recruitment Consultant on 8877 8766 for a confidential discussion.
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