at Northwestern University in Chicago, Illinois, United States
Job Description
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Job ID50402
LocationChicago, Illinois
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Department: MED-Clinical Trials Unit
Salary/Grade: EXS/8
Job Summary:
Manages all activities associated with highly complex clinical research studies.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.
Creates and nurtures collaborations and partnerships with outside affiliate institutions, clinical research organizations, and pharmaceutical partners.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: On site activity is anticipated 3-4 days per week to support clinical operations - clinical requirements will determine on site needs
Supervisor provides objectives and deadlines.Work is reviewed for fulfillment of objective and deadlines and overall compliance with policy and procedures.EE completes some activities without direction, informing supervisor only of potentially controversial matters, and/or far-reaching implications.
Specific Responsibilities:
Program Development
Assists with determining goals, objectives, outcome measurements and metrics, financial feasibility, and collaboration opportunities as it relates to clinical research with other internal and external organizations.Implements policies, procedures, and training for partners.
Directs actions to ensure high quality clinical research standards are maintained across all partner programs.
Recruit, hire, train, and supervise clinical research staff across partner programs.
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.
Directly involved with study start-up, implementation, conduct, and close-outs.
Oversees completion of study activities per protocol.Guides clinical research coordinators in collaborating with nursing staff and Principal Investigator (PI).
Manages day to day activities of clinical research teams and oversees interaction with critical clinical partners such as pharmacy, nursing, pathology core, etc.
Ensures that the conduct of 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.
Trouble-shoots emergent patient care issues with clinical teams to ensure adherence to protocol guidelines, institutional reporting policies, and federal regulations.
Leads clinical teams in preparing for internal CRO, NU IRB, Sponsor, and FDA audits.
Reviews scientific literature & evaluates & recommends applicable techniques & procedures.
Works on the development of standard operating procedures for clinical staff and also monitors compliance with procedures.
Supports enrollment of participants into new research studies
Administrative
Acts as liaison between sponsoring agencies, collaborating organizations &/or other research &/or educational institutions.
Oversees recruitment and management of clinical research staff.
Completes applications and obtains appropriate approvals from various groups for all necessary study-start-up functions.
Plans, develops & implements new processes, policies, and protocols to support research studies & maximize/extend study capabilities.
Ensures the clinical functioning of the office is efficient by providing supervision of day to day activities of multiple teams.This position will manage administrative issues related to work load for the staff, including activities such as tracking current and expected workloads and assigning new protocols to coordinators. Assists with internal audits of research charts to ensure compliance with protocol requirements.
Ensures that all study documents associated with current local, state, & federal regulatory guidelines, requirements, laws & research protocols are completed in a timely manner.
Data
Manages project data including processing, accuracy, analysis & evaluation... For full info follow application link.
Northwestern University is an Equal Opportunity, Affirmative Action Employer of all protected classes, including veterans and individuals with disabilities. Women, racial and ethnic minorities, individuals with disabilities, and veterans are encouraged to apply.
