Job Description
- The Clinical Research Associate will perform the following activities:
To successfully conduct the listed site visits as required by client/study -- PreStudy Site Selection, Site Initiation, Interim Monitoring, Site Close out
Meet with Clinical Investigators and staff prior to study initiation to ensure all aspects of the study are understood by the investigator and staff. If required train the study site team
To confirm the appropriateness of the site for the study in all aspects and ensure that all documentation required to initiate the study is complete
Monitor study progress to assure compliance with protocol requirements, FDA regulations and Good Clinical Practice by conducting site visits as directed by the Sponsor/CRO & NMI SOPs
Monitor and track patient enrollment and study progress
Perform site monitoring visits to include review of source document, case report form, ICD, Patient Diary, Investigator Site Binder, other documents as applicable
Ensure the timely accurate and complete collection and submission of study data.
Identify, address, and resolve issues and problems as they might occur.
At study completion:
Ensure collection of all data and remaining study supplies for return to the Sponsor/CRO
Ensure that appropriate study documents are complete and properly filed
Archival with Inventory list of Source documents/ CRFs/ CTM/ Others at site
Prepare the site for possible Regulatory/ FDA inspection
Prepare the site for possible Internal and/or Client Audits
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