Clinical Research Project Manager

Overview

Department: MED-Physical Med & Rehab

Salary/Grade: EXS/7

Location: Chicago, Illinois

Target hiring range for this position will be between $65,000-$77,000 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.

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), FDA CFR, and ICH.

Responsibilities:

• 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. Collaborates with nursing staff and PI to ascertain 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 study protocols comply with applicable rules and regulations; reviews study progress and recommends revisions or changes as necessary to meet sponsor needs.
• Manages conduct of experimental tests and procedures; closely monitors and documents patient adverse events; partners with nursing staff in modifying dosages, tests and treatment schedules.
• Reviews scientific literature and evaluates and recommends applicable techniques and procedures.

• Analyzes, evaluates and interprets data to determine relevance to research.
• Assists PI in developing statistical methods and models to analyze and report data based on study requirements.
• Prepares results and may co-author scientific papers for presentation and publication; disseminates information via seminars and lectures.
• 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 regulatory guidelines and protocols are completed in a timely manner.

• Manages project data including processing, accuracy, analysis and evaluation of data ensuring results meet project 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 data management and analysis issues.

• May create and/or manage research study budgets, including expenditures 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 and coordinates budget negotiations with industry sponsors.