Job Opportunities

Clinical Research Associate (CRA) - Posted On November 01 2009

Description:
Job Description
Clinical Research Associate
Purpose of Position: In our NH office, this is an experienced CRA only position responsible for monitoring of all types of clinical trials; assuring adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures.
Essential Functions:
Site Selection: Assisting with the identification and contacting of potential investigators; ensure adequacy of clinical research staff/facilities with regard to Certus/Sponsor SOPs and global regulatory requirements; identify issues and problems for resolution by the Lead CRA or Project Manager.
Study Initiation: Prepare for and conduct site initiation visits. Ensure completion of regulatory documents; review investigator responsibilities; coordinate shipment of study related materials. Assist in the preparation for and attend the investigator meetings as required.

Study Monitoring: On-Site Monitoring:· Assess overall investigational site performance
· Ensure investigator’s adherence to protocol and initiate action for proactive issue resolution
· Ensure regulatory documents are available, current and organized
· Review CRFs for completeness and accuracy and ensure that corrections are completed appropriately
· Perform source document verification
· Review adverse event incidence, both serious and non-serious, and follow reporting procedures to Certus/Sponsor
· Review Data Clarification Form resolution
· Proactive site issue resolution
· Ensure clinical trial material accountability
· Prepare trip reports, and follow-up with sites recommending corrective action where appropriate
· Maintain regular telephone contact with site
· Maintain study specific tracking files as required for each project
· Maintain written correspondence with the site as required by each project
· Keep Lead CRA/Project Manager fully appraised of site and study status
· Performs in-house clinical CRF review, if applicable
Study Termination:
· Resolve all outstanding data clarification forms
· Retrieve any remaining CRFs
· Ensure regulatory documents are available and complete
· Ensure clinical trial material accountability and clinical trial material return and disposal
· Review record retention requirements
· Secure and review investigator’s final study report
Other:
· Perform administrative duties including attendance at Certus staff meetings, project team meetings, training and orientation sessions as required.
· Maintain awareness of overall development in the field of clinical research, as well as assigned areas, by reading related literature, attending professional meetings, etc.