Clinical Research Associate
The Clinical Research Associate (CRA) 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.
CRA 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 CRA 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 CRA will assist with study monitoring oversight including reviewing monitoring plans, monitoring reports, and on occasion may be asked to assist with on-site and or remote monitoring. The CRA will also assist with 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.
Qualified Candidates will have a BA/BS degree in a health or science field, 3-5 years of experience with clinical trials (malaria trials and international sites preferred), and Good Clinical Practices certification. The successful candidate will be mission-driven, exhibit high professional standards, communicate effectively and contribute to a dynamic, collaborative team environment. Independent domestic and international travel may be required up to 15% of the time.