Research Project Manager

Clinical Trials Unit Manager

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).

On site activity typically required 4 days per week.

Target hiring range for this position will be between $63,080 - $78,849 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.

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.
• 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. 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.
• 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.

Preferred Qualifications:

Work experience in an academic medical center, clinical research core laboratory, or contract research organization (CRO) setting Experience applying AI or machine learning tools in a research setting

Competencies:

Familiarity with clinical trial regulatory frameworks (e.g., GCP, 21 CFR Part 11) Familiarity with DICOM imaging standard

Benefits:
At Northwestern, we are proud to provide meaningful and competitive benefits. The available benefits package for this position will include health, dental, vision, disability, and life insurance; paid vacation and holidays; paid medical/sick and parental leave; tuition benefits for the employee and dependents; pre-tax and flex spending accounts for commuting and dependent care; generous retirement savings options; and wellness programs.