Clinical Research Associate II with 3+ years for international CRO

September 8, 2013 by · Comments Off on Clinical Research Associate II with 3+ years for international CRO
Filed under: Clinical Research 

International CRO:
We offer a broad range of specialised services to assist pharmaceutical, biotechnology and medical device companies to bring new drugs and devices to market faster. Our services span
the entire lifecycle of product development and can be adapted to suit small local trials or large global programs.

Job Title:
CRA II office based in Rome or home-based

Job description:
Responsible for site qualification, initiation, interim monitoring, site management and study close-out visits for studies in accordance with Good Clinical Practices (GCPs) and applicable local and international regulations and Standard Operating Procedures (SOPs). Ensure quality of data submitted from study sites and assure timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel.

Responsibilities:

Tasks may include but are not limited to:

  • Perform feasibility studies for potential sites as requested
  • Conduct pre-study, study initiation and interim monitoring visits in adherence to the protocol requirements
  • Compile and ensure completeness of regulatory documents and ethical submission documentation as appropriate and required (e.g. IRB / IEC study approval, informed consent, etc.) Read more