Sanaria is currently expanding its activities and is accepting inquiries and resumes for the positions listed below. If you are interested in furthering your career with us please send the following information to email@example.com:
Sanaria is an equal opportunity employer.
AVAILABLE POSITIONS: Clinical Research Associate Research Associate - Vaccine Stabilization Medical Writer Research Associate - Gametocyte Production
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.
Qualified Candidates will have a BA/BS degree in a health or science field (Masters degree preferred), 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 international travel is required.
Research Associate - Vaccine Stabilization
The Research Associate will conduct research on cryopreservation, and work with the logistics and delivery of Sanaria's PfSPZ Vaccine. The Research Associate will also be required to perform key operations during PfSPZ Vaccine manufacture that may include mosquito dissection, vaccine formulation, sporozoite attenuation or enumeration, vialing and cryopreservation of final product, or other component procedures, and assays of PfSPZ potency.
Qualified candidates are expected to have a Bachelor's degree in Biology, Chemistry, Bioengineering, or a related field. Additionally, experience that includes sterile technique, microscopy, and cell/tissue culture is desirable. Experience in GMP manufacturing would be advantageous. Excellent communication, writing, teamwork, and organization skills and the willingness to learn new experimental and operational techniques are essential. U.S. citizenship or permanent resident status is required.
Sanaria is now embarking on an ambitious program designed to lead to licensure, and will be conducting clinical trials at multiple sites in Africa, Europe, and the United States. Sanaria is currently recruiting for a Medical Writer experienced with Clinical Protocols, Amendments, Reports, and Manuscripts, ideally with background in vaccine (or drug) development.
Research Associate - Gametocyte Production
The Research Associate will be involved in the malaria PfSPZ vaccine production process. This position involves but not limit to aseptic techniques, maintenance of parasite cultures and other aspects of GMP Manufacturing including mosquito dissection; revision and development of SOPs and batch records for Gametocyte Production team; conducting standard membrane feeding assays (SMFA) and vailing PfSPZ vaccine. The incumbent is also expected to participate in research projects targeted at optimizing the efficiency and scaling up of procedures.
Qualified candidates must have a degree in Biology or related discipline and 3 years of relevant experience. Excellent communication and interactive skills and the willingness to learn new experimental techniques are required. Experience with sterile technique, microscopy and cell culture is desirable. A background in bio-engineering is a plus. U.S. citizenship or permanent eligibility to work in the US is required.
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