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 Trial Master File Specialist / Junior Clinical Research Associate experienced with trial master file creation and administration.
The Trial Master File (TMF) Specialist 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 the retrieval, tracking and maintenance of clinical study documents in Sanaria’s electronic TMF, ensuring that all study documents are (1) in place at the start of trials, (2) maintained contemporaneously during trial conduct, (3) completed at the close of trials and (4) internally audited for full compliance with regulations. The TMF Specialist will review clinical documents (e.g. protocols, consent forms, study templates, SOPs, case report forms, etc.), support Veeva Vault eTMF® software and perform validation. The TMF Specialist may also be asked to conduct other duties as time allows, including supporting the organization and conduct of sponsor/site teleconferences, Safety Monitoring Committees teleconferences, and investigator site meetings.
Qualified Candidates will have a BA/BS degree in a health or science field, 1 year of experience with clinical study document management, 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 may require.
We offer a competitive salary and benefits package. Please send cover letter, resumé and salary history to: firstname.lastname@example.org, subject line TMF Specialist. For more information, please visit www.sanaria.com. Sanaria Inc. is an equal opportunity employer.