at Northwestern University in Evanston, Illinois, United States
Job Description
Job Opening Id: 53943
Department: MED-Gastroenterology
Salary/Grade: EXS/5
Job Summary:
Manages daily operations of a biomedical &/or social-behavioral research study involving multidisciplinary teams of colleagues, sponsors & other external project stakeholders. Monitors study performance, analyzes & review results, & supervises development & implementation of new protocols. Assigns work & supervises study staff & reviews technical operations ensuring that all processes, protocols & procedures are quality controlled & functioning up to standards. Develops implements & administers budgets, grant & administrative procedures. May co-author scientific papers for presentation & publication & coordinates writing, submission & administration of grants. Ensures that all study activities are completed by strictly following Good Clinical Practices (GCP) & all current local, state, & federal laws, regulations, guidance, policy & procedure developed by the NU Institutional Review Board (IRB), Food & Drug Administration (FDA) Code of Federal Regulations (CFR), & the International Conference on Harmonization (ICH).
Please note: Supervisor provides objectives, deadlines and specific instructions only for new, difficult, and/or unusual work. Work is reviewed upon completion and only occasionally to verify technical accuracy and compliance with practice, policy, and procedures. EE informs supervisor of on-going progress and/or potentially controversial matters.
Specific Responsibilities:
Technical
- Leads execution & control of a biomedical &/or social science project or research study.
- Coordinates processing & analysis of data, conduct of experimental tests & procedures
- Ensures completion of study activities per protocol including recruitment.
- Ascertains pretreatment & eligibility requirements.
- Obtains informed consent.
- Registers participant with appropriate sponsor.
- Interviews & obtains medical & social histories.
- Collects data from medical records.
- Administers, schedules &/or scores tests.
Administration
- Oversees & manages collection, maintenance, analysis & evaluation of data that will be used in grant submissions, presentations & publications.
