Department: MED-Center for Health Services and Outcomes Research
Salary/Grade: EXS/7

Job Summary:

This Clinical Research Project Manager will work on a federally funded research projects evaluating novel diabetes interventions to improve diabetes care.  The primary responsibility of this position will be to help plan and execute translational and interdisciplinary research projects (development of intervention [mixed methods, including user-centered design], through execution of pragmatic clinical trials, and subsequent dissemination).

The manager will plan on working with staff and collaborators/investigators across Northwestern University and Northwestern Medicine (McCormick School of Engineering, Segal Design Institute, School of Education and Social Policy, Center for Health Services and Outcomes Research, Department of Medicine, Northwestern Quality), with collaborators in other universities, with long term goals to expand and initiate relationships with other public health and non-profit entities. Long term goal is to test evidence-based interventions with the goal of ultimately scaling and supporting these interventions using novel methods for delivery to under-represented groups with diabetes at point-of clinical care, at home, and/or in the community.  The manager will be responsible for oversight, which would include regulatory requirements, protocol development, IRB, recruitment, consenting, chart review, survey administration, and data management. The Clinical Research Project Manager would be expected to contribute ideas and take the initiative to help execute research goals, including pre-implementation and implementation of pragmatic trials related to diabetes and subsequent dissemination.

The Clinical Research Project Manager will oversee day-to-day operations including identifying & securing needed resources; creating, implementing, monitoring, and updating project plans; facilitating meetings with appropriate parties; tracking tasks/deliverables to ensure timelines, milestones and/or goals are attained; monitoring & reporting progress as appropriate; and resolving or escalating issues in a timely manner. The manager may co-author scientific papers for presentation, publication, and may coordinate writing or lead writing initiatives, along with submission and administration of grants; long term growth opportunities in these areas are also available.  The candidate will need to ensure that all study activities are completed by strictly following Good Clinical Practices (GCP) and all current local, state, and federal laws, regulations, guidance, policy & procedure developed by the NU Institutional Review Board (IRB), Food and Drug Administration (FDA) Code of Federal Regulations (CFR), and the International Conference on Harmonization (ICH).

The successful candidate will have prior experience working in clinical research, be exceptionally detail-oriented, will need to collaborate effectively as an individual and in a team and contribute to building a positive team culture, have strong writing and critical thinking skills, be creative and thoughtful in proposing ideas to achieve the study goals, and be technologically proficient with the ability to learn and navigate electronic medical record systems and project databases.  A strong background or interest in the intersection of the arts and sciences would be an ideal long term fit for the interdisciplinary nature of the team on both the medical and undergraduate campus.  Candidates with prior clinical experience and prior research experience are preferred; those with several years of either clinical or research experience are welcome to inquire or apply.

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 successful candidate would have the ability to travel cross-campus if needed to meet with collaborators and/or other team members. Flexible work arrangements could be discussed pending research related benchmarks.

Specific Responsibilities:

Technical

• Provides 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.  Collaborating with nursing staff and Principal Investigator (PI) ascertains pretreatment & eligibility requirements; completes informed consent; determines & organizes patient's treatment and test schedules.
• 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.  .  Closely monitors & documents patient's adverse events; 
• Reviews scientific literature & evaluates & recommends applicable techniques & procedures.  

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.

Data

• Manages project data including processing, accuracy, analysis & evaluation of data ensuring that results meet project information and deliverable objectives.  Partners with internal/external project and IT staff to create, review, analyze, interpret, summarize and prepare progress & final reports.
• Provides consultation to internal/external project staff on appropriate data management, methodological issues and analysis of data.

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.
• Oversees purchasing supplies, materials, equipment & services.
• Ensures appropriate allocation & compliance. 
• Oversees invoices study sponsors for study tests/procedures. 
• Coordinates & participates in budgetary negotiations with applicable entities.    

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.)

• Direct first-hand IRB knowledge/skills for > 12 months
• Previous clinical trials or clinical translational research experience (including consenting and recruitment)
• Proficiency in Microsoft Office Suite Applications, including Excel and PowerPoint, familiarity with Access and/or Redcap or similar database program
• Motivated with ability to work independently, and with team skills to work in small and large teams/groups across disciplines (medical, engineering, design, learning sciences/education/simulation, quality/patient safety)

Preferred Qualifications:

• Experience or previous education in public health OR chronic disease care/management OR healthcare quality/patient safety OR clinical nursing/social work/educator
• Experience with electronic data warehouse queries for clinical research OR clinical research database management
• Prefer experience with research utilizing interventions that also have software component or previous website management/design experience

Preferred Competencies: (Skills, knowledge, and abilities)

• Direct first-hand IRB knowledge/skills for > 12 months for clinical trial(s)
• Previous experience or knowledge of REDCAP or equivalent database(s) (Access)
• Previous experience with administration of research or clinical surveys
• Previous clinical experience (e.g. phlebotomy, medication reconciliation, chart review)

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Benefits:
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