In-House Clinical Research Associate
Current- Collect, track and review investigational site records relating to subject screening and enrollment- Assist in the development of study plans and status reports- Collect, track and review all site regulatory documents- Assist with development and review of Informed Consent Forms- Interact with sites, clients, vendors and internal study team members- Maintain the clinical trials management system (CTMS) and other project tracking tools- Track study supplies and coordinate shipments of supplies to sites as needed- Manage the study Trial Master File (TMF) and ensure periodic TMF audits- Coordinate work with CRAs monitoring on-site- Perform on-site co-monitoring and remote monitoring activities as needed- Perform regular reviews of data entered by investigational site staff according to data review/monitoring guidelines