at Northwestern University in Chicago, Illinois, United States
Job Description
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Job ID50385
LocationChicago, Illinois
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Department: MED-Clinical Trials Unit
Salary/Grade: NEX/11
Job Summary:
Under the direction of the Research Manager, the position will support the Institutional Review board (IRB) regulatory submission process for IRB continuing reviews , revisions/amendments, subject recruitment materials and safety reports (UPIRSOs) being processed through the BCVI Clinical Trials Unit. The submission process includes completion of submission process in the eIRB system. This position will serve as a contact liaison for regulatory matters among the research staff and Principal Investigators, sponsoring agencies and the IRB.
Specific Responsibilities:
Assists in the preparation and tracking of IRB submissions including continuing reviews, revisions/amendments, subject recruitment materials and safety reports (UPIRSO) for BCVI CTU research studies. Completes IRB requests for modifications as needed. Maintains an open dialog with supervisor regarding the IRB process and project modifications.
Works as a liaison between research staff and the IRB. Serves as contact between sponsor, PI, project coordinators and IRB. Communicates with collaborating faculty both inside and outside the University. Maintains an open dialog with supervisor regarding project modifications and communications.
Prepares, circulates and obtains signatures on regulatory documents for new and on- going research projects. Files and maintains study related paperwork. Submits regulatory paperwork to sponsoring agencies (i.e. 1572, investigator CVs, financial disclosure forms).
Maintain regulatory binders and documentation in collaboration with the research staff and study monitors to ensure studies are in compliance with applicable regulations. .
Participates and assists with routine monitoring visits and study close-out visits ensuring regulatory documents are accounted for. Collaborates with research staff to coordinate monitoring visits.
Sends study related documents to storage and maintain the filing systems.
Supports CTU office operations
Miscellaneous
Performs other duties as assigned.
Minimum Qualifications:
Bachelor's degree knowledge or equivalent combination of experience or education from whichcomparableskills may beacquired
Minimum Competencies: (Skills, knowledge, and abilities.)
Attention to Detail Consistently displays accuracy and attention to detail
Organization Plans, organizes and schedules in an efficient, productive manner; anticipates contingencies and pays attention to detail; targets projects or initiatives that require special attention and focuses on key tasks when faced with limited time and or resources
Preferred Qualifications:
CITI certification
One year experience in research, clinical trials research, or regulatory knowledge
Preferred Competencies: (Skills, knowledge, and abilities)
Communication-Oral and Written Communicates effectively one-to-one, in small groups and in public speaking contexts; writes precise, well-organized emails, letters and proposals while using appropriate vocabulary and grammar.
Research Regulations Demonstrates knowledge of federal and state regulations governing the participation of human and animal research subjects
Team Player Seeks to build collaboration by encouraging trust, mutual respect and shared purpose among various participants in an engagement.
The target hiring range for this position will be between $19.31 per hour - $24.14 per hour. 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... For full info follow application link.
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.
