Clinical Research Associate 8/10/2016
JOB DESCRIPTIONAPPLY Sanaria Inc., a Rockville, MD based biotechnology company, offers a unique and challenging opportunity to join a world-class team to work on the development and commercialization of a live sporozoite-based malaria vaccine for use in travelers and in malaria-endemic countries. Sanaria is seeking a Clinical Research Associate.
The Clinical Research Associate will support Sanaria s clinical research program under the direction of senior members of the Clinical Department, working on both departmental and individual study assignments. This position will support compliance with Good Clinical Practices and with the Code of Federal Regulations in Sanaria s clinical trials, from pre-initiation through closeout, and from phase 1 to vaccine licensure.
Duties will include helping to: organize and conduct sponsor/site teleconferences; assist with IRB document submission; assist with the retrieval, tracking and maintenance of clinical study documents in Sanaria s electronic Trial Master File (eTMF); and ensure that all study documents are in place at the start of trials and collected at the close of trials. The Clinical Research Associate will review clinical documents (e.g. protocols, consent forms, study templates, SOPs, case report forms, etc.), help to develop and write SOPs for the Clinical Department, maintain and support Veeva Vault eTMF software, perform validation, and provide training to company and study site staff. The Clinical Research Associate will assist with reviewing monitoring plans, organizing Safety Monitoring Committees, planning and conducting site investigator meetings, and reviewing progress reports and safety reports to ensure accuracy, scientific excellence and timely submission. The CRA will liaise with the data management vendor to resolve database issues.