| Department: MED-Preventive Medicine
Salary/Grade: EXS/5 Job Summary: Manages daily operations of a biomedical &/or social-behavioral research study involving multidisciplinary teams of colleagues, sponsors & other external project stakeholders. Monitors study performance, analyzes & review results, & supervises development & implementation of new protocols. Assigns work & supervises study staff & reviews technical operations ensuring that all processes, protocols & procedures are quality controlled & functioning up to standards. Develops implements & administers budgets, grant & administrative procedures. 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 - Leads execution & control of a biomedical &/or social science project or research study.
- Coordinates processing & analysis of data, conduct of experimental tests & procedures
- Develops new &/or revised research methodologies.
- Ensures completion of study activities per protocol including recruitment.
- Ascertains pretreatment & eligibility requirements.
- Obtains informed consent.
- Registers participant with appropriate sponsor.
- Interviews & obtains medical & social histories.
- Collects data from medical records.
- Administers, schedules &/or scores tests.
Administration - Oversees & manages collection, maintenance, analysis & evaluation of data that will be used in grant submissions, presentations & publications.
- Designs and prepares documentation for qualitative and quantitative data analysis.
- Cleans and organizes data in preparation for analysis.
- Help interpret results and write reports; prepare tables, figures, and graphs for publications and presentations.
- Ensures that information is entered correctly into databases.
- Assists PI in reviewing, analyzing, interpreting, summarizing, formatting, editing, & preparing tables, charts, graphs, progress & final reports, etc.
- Coordinates 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.
Finance - Orders & maintains inventory of study supplies.
Supervision - Trains, directs, assigns duties to & supervises research staff, students, residents &/or fellows.
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 3 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 1 year 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
Minimum Competencies: (Skills, knowledge, and abilities.) - Knowledgeable in all aspects of Microsoft Office and SAS programming.
- Excellent communicator (verbal and written), team player, adaptability, collegiality, shows great initiative.
- Ability to work with minimal supervision while being responsible for accomplishing all study-related goals and objectives.
- Excellent organizational and interpersonal skills.
- Attention to detail and the ability to adapt and quickly adjust to changing work situations.
Preferred Qualifications: - Master’s degree and previous experience in the clinical research area.
Preferred Competencies: (Skills, knowledge, and abilities) - Phlebotomy and sample processing experience preferred.
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. Hiring is contingent upon eligibility to work in the United States.
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