Department: MED-Cancer Center
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).
Under general direction of the Cancer Center's Director of clinical research, this position is responsible for administration of the Lurie Cancer Center Scientific Review Committee (SRC), and Disease Team administration. As such, this person coordinates all activities associated with the Scientific Review Committee, and Disease Team protocol review. This position is responsible for processing all cancer-relevant research conducted by NU and NU affiliate institutions, ensuring that the National Cancer Institute regulations are followed regarding Comprehensive Cancer Center designation. Additionally, this position coordinates administrative processes and prioritizes, directs, and responds to business matters involving administrative functions associated with Disease Team research and/or operations. Creates and maintains associated documents, spreadsheets, databases, meetings, special events, etc. and alerts supervisor of critical issues and upcoming events.
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
- Ensures completion of study activities per protocol including recruitment.
- Responsible for the management of the protocol review process including review all new and revised protocols for scientific merit and ongoing progress monitoring.
- Collects data from medical records.
Administration
- Oversees & manages collection, maintenance, analysis & evaluation of data that will be used in grant submissions, presentations & publications.
- 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.
- Ensure all new studies are processed and registered in NOTIS, perform preliminary review of protocols and/or revisions and ensure all associated documents are submitted, assess each protocol and determine appropriate level of reviews, assign reviewers, prepare and distribute protocol materials for review. This regularly involves educating PIs and coordinators of processes and NCI requirements.
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 Northwestern's IRB CITI training before interacting with any participants & must re-certify every 3 years.
Minimum Competencies: (Skills, knowledge, and abilities.)
- Ability to establish and maintain effective working relationships with physicians, nurses, co-workers and external contacts.
- Excellent verbal and written communication.
- Good computer skills, particularly with MS Office.
- Detail-oriented and excellent organizational skills.
- Ability to work independently.
Preferred Qualifications:
- Previous coordinating experience (e.g., meeting coordination, program coordination, clinical coordination, etc.)
- Previous experience with protocol review and/or development.
- Prior experience working with oncology protocols.
Target hiring range for this position will be between $48,000-$64,500 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.
Benefits:
At Northwestern, we are proud to provide meaningful, competitive, high-quality health care plans, retirement benefits, tuition discounts and more! Visit us at https://www.northwestern.edu/hr/benefits/index.html to learn more.
Work-Life and Wellness:
Northwestern offers comprehensive programs and services to help you and your family navigate life's challenges and opportunities, and adopt and maintain healthy lifestyles.
We support flexible work arrangements where possible and programs to help you locate and pay for quality, affordable childcare and senior/adult care. Visit us at https://www.northwestern.edu/hr/benefits/work-life/index.html to learn more.
Professional Growth & Development:
Northwestern supports employee career development in all circumstances whether your workspace is on campus or at home. If you're interested in developing your professional potential or continuing your formal education, we offer a variety of tools and resources. Visit us at https://www.northwestern.edu/hr/learning/index.html to learn more.
Northwestern University is an Equal Opportunity Employer and does not discriminate on the basis of protected characteristics, including disability and veteran status. View Northwestern's non-discrimination statement. Job applicants who wish to request an accommodation in the application or hiring process should contact the Office of Civil Rights and Title IX Compliance. View additional information on the accommodations process.
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