Department: MED-Preventive Medicine
Salary/Grade: NEX/13

Job Summary:

Coordinates & completes the day to day administrative & technical activities involved in a single complex, large, nationwide or multiple moderately complex concurrent biomedical &/or social-behavioral research study(ies) involving multiple sites& /or longitudinal assessments/ interventions.  Ensures that all activities are completed by strictly following Good Clinical Practices (GCP) & all relevant 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).

The selected candidate will coordinate study operations and training of staff for the All of Us Research Program (AoURP), which is part of the Precision Medicine Initiative within the Northwestern network. AoURP is an unprecedented large-scale, multi-site study that will enroll 31,000 participants within Northwestern Medicine over 5 years. The selected candidate will oversee phlebotomy training for staff members.

This position will be based in Northwestern Medicine medical facilities in the North, Central and West suburbs of Chicago. The candidate will be responsible for recruiting participants to the research program in their region and will be expected to travel to all of the locations as need.

The selected candidate will be responsible for supervising the training of Research Assistants, implementation of participant scheduling, data collection procedures as well as engaging service providers.

This position may be required to work a varied schedule, depending on the needs of the study.

Evening and weekend work may be required if the study conducts participant visits or recruitment sessions during those times. It is anticipated that the selected candidate will arrange their schedule to ensure adequate oversight of the clinical locations and the study operations in general.

Positions may be based at one (or more) of the following locations:

• Chicago, IL,  Geveva IL or Grayslake IL

The selected candidate is expected oversee operations at all three sites as needed.

Supervisor provides objectives, deadlines and specific instructions only for new, difficult, and/or unusual work.  Work is reviewed upon completion and only occasionally to verify technical accuracy and compliance with practice, policy, and procedures.  EE informs supervisor of on-going progress and/or potentially controversial matters.   

Specific Responsibilities:

Technical

• Participates in the planning & conduct of research studies (via in-person and remotely, including phone and computer devices). 
• Reviews project & protocol & recommends strategies to expedite study. 
• Recruits & retains participants.
• Obtains informed consent.
• Administers tests &/or questionnaires following protocols.
• Collects, compiles, tabulates &/or process responses.
• Gathers information.
• Extracts & analyzes data from medical charts.
• Completes basic clinical procedures such as drawing blood & obtaining blood pressure. 
• Monitors & maintains systems for effective participant and data flow for studies. 
• Designs & constructs experimental stimuli. 
• Performs physical function assessment.  
• Closely monitors & documents patient's adverse events and report to Clinical Operations Manager as necessary
• Ensures that study protocols are in compliance with guidelines & regulations.
• Reviews study progress and recommends revisions, amendments, and/or other study changes as necessary to better meet needs of sponsors.
• Participant recruitment, presentations, attending events as needed

Administration

• Manages study databases which may include ensuring that data is collected & entered correctly.
• Reviews & analyzes data.
• Creates computer models, graphs, reports & summaries for use in publications, professional journals, & grant applications. 
• Writes portions of grant applications.
• Co-authors scientific papers for presentation & publication. 
• Researches & obtains funding. 
• Creates & maintains study manuals regarding operating, safety, and etc. procedures. 
• 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 process payments for research participants per study protocol. 
• Creates lab financial plan & budget/audit expenses.
• Obtains sales quotes for lab equipment & supplies.
• Reviews & adjusts expenses to decrease costs. 
• Oversees repair & maintenance of all lab equipment & ensures that lab supplies are ready & available when necessary. 
• Administers budget including negotiating with grant sponsors. 
• Maintains & reconciles expenditures & balances in regard to research accounts & budgets. 
• Assist in purchasing of supplies, materials, equipment & services.
• Ensures appropriate allocation & compliance. 

Supervision

• Trains, directs, assigns duties to & may supervise research staff, 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 4 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 2 years' research study or other relevant experience.
• Must complete NU's IRB CITI training before interacting with any participants & must re-certify every 3 years.

Minimum Competencies:

• Minimum of five years of phlebotomy experience
• Knowledge of all aspects of clinical research, including laboratory work, clinical exams, and supervision of staff. 
• Must be able to handle multiple responsibilities and deadlines while keeping the study on track and meeting the accrual goals. 
• Must be able to remain steady under pressure, be adaptable, take direction from others, and be a team player. 
• Must be willing to travel to, and work at, various sites around the city and/or suburbs that will be the designated locations for this study. 
• As needed, this position will need to conduct participant visits and assist other staff with their workload.
• Attention to Detail: Consistently displays accuracy and attention to detail.
• Excellent time management and communication skills.
• Ability to communicate clearly and concisely both orally and in writing
• Problem solving: Ability to troubleshoot and implement solutions

Preferred Qualifications:

• Experience working with research teams to identify, enroll, and collect data
• Knowledge of behavioral medicine research theories and methods preferred
• Develop and maintain Standard Operating Procedures (SOPs)
• Prior supervisory experience preferred.

Preferred Competencies: (Skills, knowledge, and abilities)

• An engaging and energetic personality
• Ability to transmit excitement and passion for the project to potential participants

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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 arrangem