Clinical Research Associate at Natick

Job Description

Title: Clinical Research Associate in Valencia, CAApproximate Contract Duration: 2 monthsJob Description:This assignment is to complete the close out activities associated to 10 clinical study sites following the recent suspension of a clinical study at those sites, following unmet recruitment targets.Description of the work/duties to be performed: Conduct of onsite close out Visit to ensure study close out is conducted in accordance with the protocol, SOPs ICH GCP, and other regulatory requirements. Ensures all reportable SAE/AE/SUSAR Medical device Related Events are identified, clearly documented and reported as per protocol and any other applicable requirements. Source Verification of any CRFs at site as required. Reconcile Site Documentation to include (but not limited to) Contracts, Regulatory Docs, FDF, Entry of data to applicable Databases Provides primary point of contact and communication for site staff for all study related close out activities. Completion of Monitoring reports in CTMS Ensures any identified non-compliance issues are addressed, documented and escalated as requiredSkills and experience: 2 + years experience of Clinical Site Monitoring Previous Clinical Site Close Out visit experience Experience of Medical Device trials preferred Working knowledge of ICH GCP. We will provide all related SOP and Protocol training

Job Requirements

 
Country: USA, State: Massachusetts, City: Natick, Company: InVentiv Health.