| Job Description | Mar 8, 2012
As the ProFibrix In-House CRA, you will be managing the activities of CRAs from an external CRO that will conduct all aspects of an international phase III clinical trial. You will work with the CRO and clinical sites to ensure subject safety, data integrity, and adherence to the study protocol and various regulations.
You will ensure the CRO staff and clinical sites have all information, documentation and supplies available in order to conduct the trial:
Participate in on-site qualification, initiation, monitoring and close-out visits as co-monitor
Available to travel 30%
Attend site surgical procedures for site training and support
Act as a resource to CRO CRAs for operational consistency
Provide oversight for preparation of document submissions to IRB/IECs
Review site IRB documents for IMP release
Review monitoring visit reports and provide follow-up as necessary
Review Informed Consents, Protocols, study manuals, templates and other study related documents
Function as a primary contact for CRO Clinical Trial Managers and CRAs
Ensure CRO performance per contract terms, GCP/ICH adherence and overall quality of work
Perform in-house eCRF data review and reconciliation
Monitor site drug supply needs on an ongoing basis
At study conclusion, reconcile overall drug accountability and trial master file organization and content
Ensure adequate CRO CRA training and compliance
Assist with reviewing and writing relevant SOPs, guidelines, templates and policies
Act as an ambassador representing ProFibrix to the medical and research communities
You will be responsible for overall study documentation and are expected to play an active role in the clinical team meetings:
Facilitate the flow of information among CRO, CRAs and ProFibrix team members
Participate in teleconferences across multiple time zones
Participate in study team meetings
Participate in Investigators' Meeting
Manage and maintain in-house clinical files
Maintain project tracking systems of subjects, supplies and site information
Manage study supply tracking
Assist clinical project team with assessing project feasibility and recruitment, provide clinical updates as applicable
Education:
Bachelors in scientific discipline, RN, health care professional or equivalent
Experience:
Strong knowledge of clinical research processes, ICH-GCP, federal regulations and applicable local laws pertaining to clinical research investigation
Minimum of 4 years clinical research monitoring experience in the pharmaceutical/biotechnology industry
Experience with project, vendor and contract management
Basic knowledge of medical terminology
Proficient computer skills including Microsoft Word, Excel and Outlook
Familiar with various eCRF data collection system |
| | Company | | ProFibrix, Inc. | Job Code | | State or Province | | Washington | | |
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