The Research Study Assistant position is responsible for off-site study coordination and data management oversight. The Study Assistant will provide study coordination of specific protocols – including implementing and monitoring quality control SOPs; conducting period quality assurance monitoring; and working with investigators at BMC.
The individual will work with investigators to develop case report forms consistent with clinical protocols, sets up SOPs for clinical conduct, data collection, assist site staff/investigators in study implementation and performs quality assurance audits to validate data in preparation for analysis by biostatisticians.
Understanding of clinical research components – data collection issues, human subjects protection, quality assurance and control.
Familiarity with ICH Good Clinical Practices (GCP) consistent with registration clinical trials (FDA Guidance for Industry for Computerized Systems used in Clinical Trials (Title 21 CFR Part 11) preferred.
Excellent programming ability in SAS statistical software is required. Knowledge of other programming and other scripting language is advantageous.
Intermediate proficiency with Microsoft Office applications, use of file transfer protocols (FTP) preferred.
Proficiency in a high level programming language preferred.
Working knowledge of electronic data capture systems, specifically, Teleform (Autonomy Cardiff, Vista, CA) software preferred.
Ability to learn and assimilate other related computer applications into data management practices.
Demonstrated progressive work experience in project management and project planning.
Excellent oral and written communication skills.
Great interpersonal skills and flexibility to work in a collaborative environment.
Excellent organizational skills, including ability to multi-task, set priorities and meet timetables while managing several simultaneous projects.
Bachelors' degree required, preferably in Public Health.
MS/MPH strongly preferred.
Must have minimum of two (2) years' experience with statistical analysis software (SAS), understanding of data management in clinical research and experience with clinical/epidemiologic research, especially in international health/infectious diseases.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, protected veteran status, or any other characteristic protected by law. We are a VEVRAA Federal Contractor.
Internal Number: 6939
About Boston University
Boston University is no small operation. With over 33,000 undergraduate and graduate students from more than 140 countries, 10,000 faculty and staff, 16 schools and colleges, and 250 fields of study, our two campuses are always humming.