Clinical Trial Coordinator - Cell Therapy Laboratory

Salary Range

The salary range for this position is $37.79 - $54.80 (Hourly Rate). Placement within the salary range is dependent on several factors such as relevant work experience and internal equity. For positions represented by a labor union, placement within the salary range is guided by the rules outlined in the collective bargaining agreement.

• $10,000 Tuition Reimbursement per year ($5,700 part‑time)
• $10,000 Student Loan Repayment ($5,000 part‑time)
• $1,000 Professional Development per year ($500 part‑time)
• $250 Wellbeing Fund per year ($125 for part‑time)
• Matching 401(k)
• Excellent medical, dental and vision coverage
• Life insurance
• Annual Employee Salary Increase and Incentive Bonus
• Paid time off and Holiday pay

The Clinical Trial Coordinator reflects the mission, vision, and values of NM, adheres to the organization’s Code of Ethics and Corporate Compliance Program, and complies with all relevant policies, procedures, guidelines and all other regulatory and accreditation standards.

Under the direction of the Manager, the Clinical Trial Coordinator supports, facilitates and coordinates the daily clinical trial and commercial product activities and plays a critical role in the conduct of the study or commercial product process. By performing these duties, the Clinical Trial Coordinator works with the department management, sponsor, Northwestern University (NU) and institution to support and provide guidance on the administration of the compliance, financial, personnel and other related aspects of the clinical study or commercial product process.

The individual must have excellent written and oral communication skills and proven ability to work independently with minimal supervision. Candidate must be detail oriented. Individual must have the ability to review and maintain metrics. The position requires proficiency with MS office applications as well as special knowledge of hospital and laboratory systems. The variable nature of the work performed requires demonstrated problem‑solving capabilities.

The individual must possess high moral and ethical standards.

• Mathews Center for Cellular Therapy (MCCT) liaison between NU study coordinators and Lurie Children’s Hospital study coordinators as well as between NMH and Lurie Children’s commercial process coordinators
• Obtaining and organization of clinical trial and commercial process documentation – protocols, study manuals, study SOPs, forms, IRB approval, Biosafety SOP (as applicable), memos, training
• Reviews and comprehends the clinical trials and commercial processes
• Perform feasibility analysis of clinical trials and commercial processes at MCCT determining capability, logistics, personnel, supplies and equipment needs
• Participation in SIV, SQVs and arrange for necessary staff members to attend. Follow up with clinical trial and commercial product sponsors as necessary following the initiation visits
• Prepare and justify clinical trial and commercial process budgets including staff time, equipment and supply usage, and quality aspects
• Prepare clinical trial and commercial process charge codes and work with Finance and Information Systems to build codes and set up in EPIC
• Assist manager and Office of General Counsel in reviewing and revising clinical trial quality agreements, non‑disclosure agreements, and clinical trial arrangements between NU and MCCT as well as Lurie Children’s Hospital and MCCT
• Assist manager with clinical trial and commercial process related Equipment Short Term Lease Agreement documentation and process by communicating with sponsors, NM Office of Research, Purchasing, Property Accounting and Biomedical Engineering
• Interacting with NU to obtain and maintain active IRB clinical trial documentation
• Ensure that clinical trials and commercial processes related to the MCCT are performed in accordance with federal regulations, NM and NU policies and procedures
• Participate in clinical trial and commercial process meetings – leadership, biosafety, participant care, and sponsor, as applicable
• Coordinate clinical trial administrative fees processing, both initial and annual
• Development of MCCT SOPs…