Clinical Trial Coordinator - Cell Therapy Laboratory, Full-Time, Days

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.

Responsibilities:

ESSENTIAL FUNCTIONS:

• 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 and associated forms for clinical trials and commercial processes
• Perform clinical trial and commercial process training of MCCT staff
• Ensures and maintains proof that all MCCT staff ‘engaged’ in the clinical trials or commercial processes have met training requirements in accordance with federal regulations, NM, NU, and sponsoring agency policies and procedures.
• Ensure sufficient clinical trial and commercial process supplies inventory and verification of expiration dates
• Ensure clinical trial and commercial process product accountability
• Participate in clinical trial and commercial processes procedures, on a backup basis
• Coordinate clinical trial procedures and commercial processes scheduling in MCCT – including processing, shipping, receiving, storing, and infusion preparation
• Work with the MCCT quality staff to perform RCA and CAPA as it pertains to clinical trials or commercial products as necessary. Report back to the sponsor events and associated RCA & CAPA
• Ensure staff are informed of their role in clinical trials and commercial products and arrange coverage in times of staff PTO
• Establishes, organizes, and retains clinical trial and commercial processes files, including but not limited to, regulatory binders, specific source documentation and other materials such as protocols, manuals, forms and batch records
• Coordinate clinical trial and commercial process billing and verification
• Work with NM Office of Research to ensure correct charging of clinical trial activities
• Participate in clinical trial and commercial process audits
• Coordinate clinical trial closure process by arranging secure storage of documents that will be maintained according to NM, NU, and clinical trial and commercial process policies or for the contracted length of time, whichever is longer.

Leadership/problem solving responsibilities:

• Adheres to Patients First management standards on leadership, communication and visibility.
• Coordinates critical situations involving clinical trial or commercial process patients and consults with Manager and trial or commercial administrators for guidance, as needed
• Promotes philosophy and objectives of the hospital, division and department.
• Identifies and communicates key issues and trends to Manager.

Technical responsibilities:

• Adheres to hospital and department policies and procedures.
• Participates in and presents at meetings.
• Performs other duties as assigned.

Quality management responsibilities: 

• Participates in departmental quality improvement activities related to clinical trials and commercial processes.
• Collects data to support the measurement and tracking of quality management related to clinical trials and commercial processes.
• Participates in the incorporation of results of QM audits in the improvement of services and enhancement of clinical trials and commercial processes for patient care consistent with hospital policies
• Provides ideas and suggestions for process improvements within the department.
• Communicates customer satisfaction issues to appropriate individuals.