Sanaria Inc., an award-winning biotechnology company based in Rockville, Maryland, USA, offers a unique and challenging opportunity to join a world-class team developing and commercializing a live sporozoite-based malaria vaccine for use in international travelers and in residents of malaria-endemic countries, where malaria causes half a million deaths each year, mostly in children. Sanaria is conducting clinical trials at multiple sites in Africa, Europe, and the United States aiming for licensure in the next few years. Sanaria is seeking a Senior Clinical Research Associate (Sr. CRA) to support Sanaria’s clinical research program under the direction of the Chief Medical Officer, working on both departmental and clinical trial 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 Phase 3 to vaccine licensure.
Sr. CRA duties will include organizing and conducting sponsor/site teleconferences; assisting with IRB document submission; assisting with the retrieval, tracking and maintenance of clinical study documents in Sanaria’s electronic Trial Master File (eTMF); and ensuring that all study documents are in place at the start of trials and collected at the close of trials. The Sr. CRA will review clinical documents (e.g. protocols, consent forms, study templates, SOPs, case report forms), 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 Sr. CRA will assist with creating monitoring and risk management plans, organize Safety Monitoring Committees, plan and conduct site qualification visits and site investigator meetings at clinical sites, write site qualification reports, assure that sites are fully compliant prior to trial initiation, provide initiation letters, and review the monitoring reports of external monitors, site progress reports and trial safety reports, to ensure accuracy, compliance and timely completion.
Qualified Candidates will have a bachelor’s or master’s degree in a science- or public health-related field, at least 5 years of experience as a CRA with malaria trials and international sites preferred, and GCP certification. The successful candidate will be mission-driven, exhibit high professional standards, and communicate effectively as a member of a collaborative team, and must be willing and available for international travel to visit clinical sites.
We offer a competitive salary and benefits package. Please send cover letter, resumé and salary history to: firstname.lastname@example.org, subject line Senior Clinical Research Associate. For more information, please visit www.sanaria.com. Sanaria Inc. is an equal opportunity employer.