Job Description Summary:
The department of Microbiology Immunology and Tropical Medicine (MITM) at GW has an opening for a full-time Senior Research Assistant in its Clinical Research Group. This position will work under the supervision of Dr. David Diemert, MD. The Clinical Research Group (MITM-CRG) is part of the GW's Research Center for Neglected Diseases of Poverty and of the Sabin Vaccine Institute product development partnership (PDP) and conducts clinical research trials of experimental products that are being developed for the prevention of neglected tropical diseases, particularly hookworm infection and schistosomiasis. We are working to develop and test a novel, low-cost hookworm vaccine to help control human hookworm infection in endemic countries. Hookworm infection causes anemia and can lead to problems with physical and cognitive development in children. For more information, please visit our web page : http://smhs.gwu.edu/mitm-crg/
The Senior Research Assistant will support Dr. Diemert and the MITM clinical research team in all the aspects of the clinical trial research activities. Current clinical trials are conducted at sites in the United States, Brazil, and Africa. The individual will analyze data, and assist in the preparation of electronic and paper regulatory submissions, program reports, funding proposals, work plans and correspondence as needed.
Responsibilities include: Provides administrative support for the clinical research team in the preparation of electronic and paper regulatory and ethical committee submissions, program reports, funding proposals, work plans and correspondence (including preparation, proofreading, formatting and editing of programmatic documents and presentations, and filing both physical and electronic program and regulatory files);
Maintains trial master files, studies site records and files and ensure compliance with applicable standard operating procedures and regulations;
Assists with periodic review of study files for accuracy and completeness;
Assists in the development of technical research documents and operational technical resources (i.e., clinical trial protocols, informed consent forms, case report forms, annual reports, regulatory submissions, clinical trial reports, clinical development plans);
Maintains and disseminates clinical trial tracking information; manages program invoices and purchase orders;
Coordinates tasks, schedules, and compilation of reports and minutes of the clinical trial unit activities and procedures;
Assists in the creation of clinical trial databases, ongoing data management, and data analysis;
Assists in the development and implementation of recruitment strategies to increase patient enrollment into clinical trials;
This position performs other duties as assigned. The omission of specific duties does not preclude the supervisor from assigning duties that are logically related to the position
Preferred Qualifications:Bachelor's Degree in the Biological Sciences
1-3 years experience supporting research in a health-related field
Proficiency with MS Word, Excel and Publisher, Project Management software such as MS Project and EndNote (or other reference management software).
Excellent written and oral communication skills
Ability to multitask, problem solve, set and meet deadlines
Ability to work collaboratively with all levels of staff and range of personalities, culture, and working styles
Excellent project management and organizational skills
Ability to perform detail-oriented work with a high level of accuracy
Knowledge of spoken and written Portuguese is an asset
Prior experience with clinical trials is a plus.
A BA/BS in related discipline and 1 year of experience in the field or in a related area.