Department: MED-Preventive Medicine
Salary/Grade: EXS/7

Job Summary:

This positions works closely with the study staff at the clinical centers for purposes of data entry training, querying data entry from sites in the REDCap Database, contributing to ongoing data monitoring, and scheduling meetings with sites for start-up training or refresher trainings that may either be remote or require travel to the site. Additionally, this position will require extensive notetaking, meeting minutes recording, and other miscellaneous regulatory organizational tasks as related to Data Use Agreements (DUA) and Material Transfer Agreement (MTA). Lastly, the position will require extensive writing for protocol updates, manual of procedures creation, instruction manual writing, and document version control.

This position will report to the NUDACC Director of Research Oversight & Compliance. NUDACC (https://www.feinberg.northwestern.edu/sites/nudacc/) consists of two tightly integrated teams: the data analysis team, and the project management/compliance team. This position sits on the project management side with database responsibilities. While this position closely communicates with the data analysis team, this position will NOT have direct data analysis or programming responsibilities. This position will focus on the PCORI Study (https://www.pcori.org/research-results/2023/comparative-effectiveness-two-aspirin-doses-prevention-hypertensive-disorders-pregnancy) with some effort for the Liver Cirrhosis Network studies (https://www.lcnstudy.org).

This position is housed within the Northwestern University Data Analysis and Coordination Center (NUDACC: https://www.feinberg.northwestern.edu/sites/nudacc/) within the Department of Preventive Medicine, Division of Biostatistics.

Please note: Supervisor provides objectives and deadlines. Work is reviewed for fulfillment of objective and deadlines and overall compliance with policy and procedures. EE completes some activities without direction, informing supervisor only of potentially controversial matters, and/or far-reaching implications.

Specific Responsibilities:

Technical

* Plans, develops & implements new processes & protocols to support research studies & maximize/extend study capabilities.

* Oversees completion of study activities per protocol.

* 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.

* Provides complex technical leadership in determining research priorities in regard to meeting the study's data objectives by creating and implementing processes for data maintenance (i.e. data query timelines, data query resolution, data query training schedules for sites.

* Identifies workflow gaps and areas for process improvement.

* Effectively collaborates with peers and managers to create and implement process improvement workflows.

* Creates manual of procedures for site training purposes and study-wide implementation.

* Continues and maintains version control for existing and new documents.

Administrative

* 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.

* Ensures data is not entered or shared from the clinical centers without meeting proper local, state, & federal regulatory guidelines (e.g. IRB approval, DUA fully executed, MTA fully executed, etc.)

* Collaborates across NU and clinical sites for executions of DUAs and MTAs.

Finance

* May negotiate prices & specifications with vendors.

* May monitor any incoming invoices for accuracy.

Supervision

* Acts as a mentor in regard to education of junior coordinators.

* Trains, directs, assigns duties to and may supervise Research Project Coordinator and or assistants, when applicable.

Miscellaneous

Performs other duties as assigned.

Minimum Competencies: (Skills, knowledge, and abilities.)

* Excellent written and oral communication skills,

* Strong organization and interpersonal skills.

* Computer expertise include literacy in Microsoft Office, internet and database use.

Preferred Qualifications:

* Previous experience working with the REDCap Database, specifically, querying.

* Previous experience writing manual of procedures and study protocols.

* Previous experience handling Data Use Agreements and Material Transfer Agreements.

* Previous experience working on multi-site biomedical studies, including experience with study-start up training and maintenance training.

Preferred Competencies: (Skills, knowledge, and abilities)

* Previous project management experience with multi-site coordination,

* Familiarity with REDCap database management,

* Familiarity with case report forms, document management and version control

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.

Target hiring range for this position will be between $61,242-$76,552 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.

Northwestern strongly recommends COVID-19 vaccinations and boosters for people who can obtain them as a critical tool for minimizing severe illness. More information can be found on the COVID-19 and Campus Updates webpage.

The Northwestern campus sits on the traditional homelands of the people of the Council of Three Fires, the Ojibwe, Potawatomi, and Odawa as well as the Menominee, Miami and Ho-Chunk nations. We acknowledge and honor the original people of the land upon which Northwestern University stands, and the Native people who remain on this land today.

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. Click for information on EEO is the Law.

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