at Northwestern University in Evanston, Illinois, United States
Job Description
Job Opening Id: 53689
Department: MED-Cardiology
Salary/Grade: EXS/7
Job Summary:
Manages all activities associated with biomedical &/or social-behavioral research studies considered very complex by the inclusion of several of the following: multiple investigators, teams, sites, sub-contracts, participants, longitudinal assessments/ interventions; &/or multi-million dollar budgets. Ensures completion of contract requirements & client specifications. Oversees day-to-day operations including identifying & securing needed resources; creating, implementing, monitoring, & updating project plans; facilitating meetings with appropriate parties; tracking tasks/deliverables to ensure timelines, milestones &/or goals are attained; monitoring & reporting progress as appropriate; & resolving or escalating issues in a timely manner. 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 overall objectives. Work is reviewed for fulfillment of objectives & adherence to policy &/or financial &/or legal requirements. EE completes activities without direction & with a great deal of job autonomy, recommending actions to supervisor in regard to major or far-reaching new or unusual circumstances.
Specific Responsibilities:
Technical
- Provides complex scientific & technical leadership in determining research priorities & the plan, design & execution of research projects ensuring that programs of investigation meet specified objectives.
- Plans, develops & implements new processes & protocols to support research studies & maximize/extend study capabilities.
- Oversees completion of study activities per protocol.
- Ensures that study protocols are in compliance with appropriate rules & regulations & reviews study progress and recommends revisions, amendments, and/or other study changes as necessary to better meet needs of sponsors.
- Reviews scientific literature & evaluates & recommends applicable techniques & procedures.
Administrative
