You’ll need
Licensure
Understanding of DEA controlled substance regulations, including storage, security, inventory, and recordkeeping. preferred
Certifications
Formal training certificate (e.g., SoCRA, CRA), coursework, and/or experience in project management. preferred
Education
✓Master's in relevant field AND 3 years of relevant experience in clinical or human-subjects research.
✓Equivalent combination of Bachelor's in relevant field in conjunction with training and experience may be considered.
Master’s degree in a relevant field and at least 5 years of progressively responsibleexperience in clinical or human subjects research, including experience with complex,longitudinal, interventional, and/or federally funded research studies, as well as at least 2 years of experience performing preferred
Qualifications
✓Experience in clinical or human-subjects research, including experience with complex, longitudinal, interventional, and/or federally funded research studies), and understanding of human-subject regulatory requirements, such as GCP (GoodClinical Practice), FDA/ICH requirements, IRB processes
✓Experience performing research project, program, or laboratory management functions, including coordinating day-to-day operations across multiple concurrentstudies or projects.
✓Background in workplace or public health interventions (safety, health or well-being),healthcare, academic institution, construction or first-responder industries within the last 5 years.
✓Demonstrated ability to develop and maintain project plans, timelines, milestones, staffing plans, and deliverables and independently track work through completion.
✓Demonstrated proficiency developing or implementing SOPs, regulatory tracking systems, and quality-control procedures.
✓Demonstrated proficiency supporting grant submissions, progress reports, manuscripts, and scientific presentations.
✓Skill in providing functional leadership to research staff, including assigning andprioritizing daily activities, monitoring completion and quality of work, training andmentoring staff, identifying missed deadlines or performance concerns, and escalating concerns to the PI or appropriate supervisor.
✓Demonstrated proficiency and experience overseeing human-subjects research and IRB activities across the study lifecycle, including study start-up, data-quality practices, regulatory compliance, amendments, continuing review/reporting requirements, protocol deviations, and study close-out.
✓Demonstrated ability to coordinate research activities across investigators, research staff, institutional offices, research cores, vendors, and/or other external entities, including research sponsors, regulatory agencies and community stakeholders.
✓Demonstrated proficiency with research data management systems such as REDCap, including oversight of study setup, data completeness, and data-quality processes.
✓Proficiency with Microsoft Office and project management/tracking tools.
✓Demonstrated project-management skills, including the ability to simultaneously manage multiple complex research projects; establish priorities, dependencies, timelines, and milestones; and consistently drive activities to timely completion.
✓Occasional schedule flexibility may be required for time-sensitive study or regulatory needs; however, routine evening, overnight, and weekend work is not expected. The position requires regular on-site work and may require occasional travel. Some teleworking may be negotiated.
Experience in research involving sleep/circadian rhythms, cannabis or substance use, occupational health, or first-responder populations. preferred
Knowledge/use of project management approaches and tools for tracking responsibilities, dependencies, timelines, milestones, and deliverables. preferred
Experience in data collection, management, and processing, including computing descriptive statistics and making charts and graphs. preferred
Prior involvement in studies regulated under an FDA IND or IDE (Investigational Device Exemption. preferred
Ability to draft, implement, and oversee standard operating procedures (SOPs) for handling Schedule I substances. preferred
Prior experience with grant writing, progress reports, or manuscript preparation. preferred
Additional Details preferred
Working hours are typically weekday daytime hours. This is a 0.5 FTE position with work hours distributed across at least four weekdays to provide continuity for research operations, staff coordination, and project oversight. preferred
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About the role
The research project manager (RPM)will oversee a diverse portfolio of research projects and a team of research staff under the direction of Dr. Nicole Bowles (PI and supervisor).