Clinical Research Project Manager
2 weeks ago
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).
**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. 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 & recommends applicable techniques & procedures.
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.
- 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 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
- May create &/or manage research study budget which may include deciding on & approving expenditures of funds based on budget.
- Monitors accounts.
- Negotiates prices & specifications with vendors.
- Purchases supplies, materials, equipment & services.
- Ensures appropriate allocation & compliance.
- Invoices study sponsors for study tests/procedures.
- Coordinates & participates in budgetary negotiations with industry sponsors.
Supervision
- Trains, directs, assigns duties to & may supervise lab EEs, students, residents &/or fellows.
- Acts as a mentor in regard to education of junior coordinators.
- Performs other duties as assigned.
Target hiring range for this position will be between $65,000 - $82,500 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.
**Minimum Qualifications: (Education, experience, and any other certifications or clearances)**
- 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' resear
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