Clinical Research Project Manager

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 : On site activity required 4-5 days per week per clinical requirements

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

• 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. Collaborating with nursing staff and Principal Investigator (PI) ascertains pretreatment & eligibility requirements;
• interviews participants & obtains social & medical histories; based on results determines & registers participants with appropriate sponsors;

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.

Manages conduct of experimental tests & procedures. Closely monitors & documents patient's adverse events; partners with nursing staff in modifying dosages, tests & treatment schedule.

• Reviews scientific literature & evaluates & recommends applicable techniques & procedures.
• Refines study screening activities including development of electronic data warehouse (EDW) data pulls

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.
• May manage submission of regulatory documents to the IRB, including development of informed consent forms.

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.
• Develop and support build of study related databases

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.
• May supervise study staff members

Miscellaneous

Performs other duties as assigned.

Minimum Qualifications :

A bachelor's degree in a social or health science + 5 years experience; or 7 years practical research study or related experience;

or a master's degree in a social or health science + 3 years 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.

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

• Computer Proficiency, especially Microsoft Word and Excel
• Demonstrates ability to work on multiple projects simultaneously
• Excellent communication skills

Preferred Qualifications :

• Experience working with the cardiovascular population
• Experience developing IRB submissions and support of regulatory submissions

Preferred Competencies : (Skills, knowledge, and abilities)

• Strong understanding of research regulations including IDE and IND
• Enhanced clinical understanding of the cardiovascular population
• Familiarity with hospital electronic systems (i.e. electronic medical records)
• Experience building research databases

Target hiring range for this position will be between $ 63,079.00 -$ 78,849.00 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.

Benefits :

At Northwestern, we are proud to provide meaningful, competitive, high-quality health care plans, retirement benefits, tuition discounts and more! Visit us at 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 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 to learn more .

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More information can be found on the 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.