Clinical Research Project Manager

Target hiring range for this position will be between $63,079 - $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.

About the role

Manages all activities associated with biomedical and/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, and/or multi-million dollar budgets. Ensures completion of contract requirements and client specifications. Oversees day-to-day operations including identifying and 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 and reporting progress as appropriate; and resolving or escalating issues in a timely manner.

May co-author scientific papers for presentation and publication and coordinates writing, submission, and administration of grants. Ensures that all study activities are completed by strictly following Good Clinical Practices (GCP) and all current local, state, and federal laws, regulations, guidance, policy, and 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). On-site activity required 4-5 days per week per clinical requirements.

Responsibilities

Technical

• Provides complex scientific and technical leadership in determining research priorities and the plan, design, and execution of research projects ensuring that programs of investigation meet specified objectives.
• Plans, develops, and implements new processes and protocols to support research studies and maximize/extend study capabilities.
• Oversees completion of study activities per protocol. Collaborating with nursing staff and Principal Investigator (PI) ascertains pretreatment and eligibility requirements; interviews participants and obtains social and medical histories; based on results determines and registers participants with appropriate sponsors; completes informed consent; determines and organizes patient's treatment and test schedules.
• Ensures that study protocols are in compliance with appropriate rules and regulations and 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 and procedures. Closely monitors and documents patient's adverse events; partners with nursing staff in modifying dosages, tests, and treatment schedule.
• Reviews scientific literature and evaluates and recommends applicable techniques and procedures.

Administrative

• Analyzes, evaluates, and interprets data to determine relevance to research.
• Assists PI in developing statistical methods and models to analyze and report data based upon study requirements.
• Prepares results and may co-author scientific papers for presentation and publication and disseminates information via seminars, lectures, etc.
• Creates data for use in grant submission and develops new proposals for research including obtaining financial support.
• Acts as liaison between sponsoring agencies, collaborating organizations, and/or other research and/or educational institutions.
• Ensures that all study documents associated with current local, state, and federal regulatory guidelines, requirements, laws, and research protocols are completed in a timely manner.

Data

• Manages project data including processing, accuracy, analysis, and 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 and final reports.
• Provides consultation to internal/external project staff on appropriate data management, methodological issues, and analysis of data.

Finance

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

Supervision

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

Requirements

• 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 and must re-certify every 3 years.

Preferred Qualifications

• Experience working with the cardiovascular population.
• Experience coordinating IND and IDE studies.

Preferred Competencies

• Enhanced clinical understanding of the cardiovascular population.
• Familiarity with hospital electronic systems (i.e., electronic medical records).
• Experience building research databases.

Benefits

At Northwestern, we are proud to provide meaningful and competitive benefits. The available benefits package for this position includes:

• 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.
• Wellness programs.

For a comprehensive overview of available benefits, including eligibility details, visit Northwestern Benefits.

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 Work-Life and Wellness to learn more.

Professional Growth and 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 Professional Growth and Development to learn more.