Clinical Research Project Manager

Biomedical/Social-Behavioral Research CoordinatorManages 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).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. 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.Administrative: 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. Acts as liaison between sponsoring agencies, collaborating organizations &/or other research &/or educational institutions. 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 of data ensuring that results meet project information and deliverable objectives. Partners with internal/external project and IT staff to create, review, analyze, interpret, summarize and prepare progress & final reports. Provides consultation to internal/external project staff on appropriate data management, methodological issues and analysis of data.Finance: Negotiates prices & specifications with vendors. Ensures appropriate allocation & compliance. Coordinates & participates in budgetary negotiations with industry sponsors.Supervision: Acts as a mentor in regard to education of junior coordinators. Miscellaneous: Performs other duties as assigned.Minimum Qualifications: Successful completion of a full 4-year course of study in an accredited college or university leading to a bachelor's or higher degree in a major such as social or health science or related; OR appropriate combination of education and experience and 5 years' research study or other relevant experience required; OR Successful completion of a full course of study in an accredited college or university leading to a master's or higher degree in a major such as social or health science or related; OR appropriate combination of education and experience and 3 years' research study or other relevant experience. Supervisory or project management experience required. Must complete NU's IRB CITI training before interacting with any participants & must re-certify every 3 years.