Clinical Research Project Manager

Job ID54762

Location

Chicago, Illinois

Department: MED-Obstetrics & Gynecology

Salary/Grade: EXS/7

Target hiring range for this position will be between $63,080 - $75,000 per year. Offered salary will be determined by the applicant’s education, experience, knowledge, skills and abilities, as well as internal equity and alignment with market data.

Manages all activities associated with biomedical & 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).

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.

• 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. Collaborating with nursing staff and Principal Investigator (PI) ascertains pretreatment & eligibility requirements; interviews participants & obtains social & medical histories; based on results determines & registers participants with appropriate sponsors; completes informed consent; determines & organizes patient's treatment and test schedules.
• 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. Manages conduct of experimental tests & procedures. Closely monitors & documents patient's adverse events; partners with nursing staff in modifying dosages, tests & treatment schedule.
• Reviews scientific literature & evaluates & recommend applicable techniques & procedures.

• Analyzes, evaluates & interprets data to determine relevance to research.
• Assists PI in developing statistical methods & models to analyze & report data based upon study requirements.
• Prepares results & may co-author scientific papers for presentation & publication & disseminates information via seminars, lectures, etc.
• Creates data for use in grant submission & develop new proposals for research including obtaining financial support.
• Acts as liaison between sponsoring agencies, collaborating organizations & or other research & or educational institutions.
• Ensures that all…