Department: MED-Obstetrics & Gynecology
Salary/Grade: EXS/7   #LI-SZ1

Job Summary:

Manages all activities associated with biomedical &/or social-behavioral research studies considered very complex by the inclusion of several of the following: multiple investigators, teams, sites, sub-contracts, participants, longitudinal assessments/ interventions; &/or multi-million dollar budgets.  Ensures completion of contract requirements & client specifications.  Oversees day-to-day operations including identifying & securing needed resources; creating, implementing, monitoring, & updating project plans; facilitating meetings with appropriate parties; tracking tasks/deliverables to ensure timelines, milestones &/or goals are attained; monitoring & reporting progress as appropriate; & resolving or escalating issues in a timely manner.   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).

Please note: A flexible schedule may occasionally be required and qualified applicants should have the ability to work evenings and weekends as needed.

Specific Responsibilities:

Technical

• Provides complex scientific & technical leadership in determining research priorities & the plan, design & execution of research projects ensuring that programs of investigation meet specified objectives. 
• 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. 
• Reviews scientific literature & evaluates & recommends applicable techniques & procedures.  
• Participates in grant and manuscript writing, preparation, and submission

Administrative

• Analyzes, evaluates & interprets data to determine relevance to research. 
• Assists PI in developing statistical methods & models to analyze & report data based upon study requirements. 
• Prepares results & may co-author scientific papers for presentation & publication & disseminates information via seminars, lectures, etc. 
• Creates data for use in grant submission & develop new proposals for research including obtaining financial support. 
• 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.

Finance

• May create &/or manage research study budget which may include deciding on & approving expenditures of funds based on budget.
• Monitors accounts.
• Negotiates prices & specifications with vendors.
• Purchases supplies, materials, equipment & services.
• Ensures appropriate allocation & compliance. 
• Invoices study sponsors for study tests/procedures. 
• Coordinates & participates in budgetary negotiations with industry sponsors.    

Supervision

• Trains, directs, assigns duties to & may supervise lab EEs, students, residents &/or fellows. 
• Acts as a mentor in regard to education of junior coordinators. 

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 5 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 3 years' 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.)

• A bachelor's degree in a social or health science + 3 years of experience; or 5 years practical research study or related experience; or a master's degree in a social or health science + 1 year experience is required. 
• Supervisory or project management experience required.
• Must complete NU's IRB CITI training before interacting with any participants & must re-certify every 3 years
• Multi-tasking, ability to work on multiple projects simultaneously

Preferred Qualifications:

• Proficiency with Microsoft Office (Excel, Powerpoint, Word, Access) and statistics software program(s)

Preferred Competencies: (Skills, knowledge, and abilities)

• Eligible for Clinical Research Certification (CCRP, CCRC, CCRA) or willing to complete certification
• Experience with EPIC and/or Powerchart
• Familiarity with HIPAA requirements
• Communicates effectively orally in individual and group contexts and writes well-organized emails, letters, and proposals while using appropriate vocabulary and grammar

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 requires all staff and faculty to be vaccinated against COVID-19, subject to limited exceptions. For more information, please visit our COVID-19 and Campus Updates website.

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.