Clinical Research Coordinator

Clinical Research Coordinator

Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.

Client develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine.

Client provides medicines for an array of health concerns in several therapeutic areas, including: attention deficit hyperactivity disorder (ADHD), cardiovascular disease, general medicine (acid reflux disease, infectious diseases), mental health (bipolar I disorder, schizophrenia), neurologics (Alzheimer's disease, epilepsy, migraine prevention and treatment), pain management, and women's health. Their ultimate goal is to help people live healthy lives. They have produced and marketed many first-in-class prescription medications and are poised to serve the broad needs of the healthcare market - from patients to practitioners, from clinics to hospitals.

The Temperature Management Coordinator is responsible for day to day the execution management of the Temperature Management & Control for Clinical Supplies clinical supplies during the execution phase of clinical trials consistent with GMP guidelines with a specific focus on Temperature Management & Control of Clinical Supplies. This individual will follow standard operating procedures.

Responsible for management of to all evaluate all temperature excursions associated to clinical supplies during the trial execution ensuring prompt resolution and compliance with all SOP, GMP, Quality, and Regulatory guidelines, contributing to successful subject dosing within Janssen Pharma R&D for all phases of clinical trials. Act as a single point of contact accountable for the business critical need.

Manage and adjust supply dispositions via inventory systems including IVR & IWR based on the outcome of the temperate out of range evaluation. Conduct issue resolution activities for the temperature excursion supply aspects of the clinical trials.

This individual will Develop strong internal collaboration with collaborate with GCDO, DPD, and Quality stakeholders to ensure for TOR resolution and overall customer satisfaction. Interface with Global Trial Managers, Trial Supply Managers, Drug Product Development, and Quality to manage trial supply temperature excursions. Responsible for execution of Temperature Monitoring Coordinator role during trial feasibility and throughout trial execution driving robust temperature management within company for all phases of clinical trials.

They conduct the Review and approval of all Investigational Site Temperature Management Equipment Questionnaire Approvals (TMEQ) for Cold Chain IMP. Act as subject matter experts for They serve as subject matter consultants on temperature management requirements including storage and monitoring capabilities. They Customizing customize protocol specific temperature out-of-range forms based on product attributes. Coordinating Obtain quotes request and complete PO setup process to centrally source temperature monitoring devices. Develop strong internal collaboration with GCO stakeholders to ensure customer satisfaction. Partner with Global Trial Managers, Local Trial Managers, Site Managers, Local Medication Coordinators, Clinical Supplies Design Leaders, and Central Business Operations in temperature management and issue resolution. Supports Contribute to business process improvement initiatives. Responsible for the Temperature Management & Control of all clinical supplies from feasibility throughout trial execution in company

A minimum of a High School Diploma is required. A Bachelor's Degree is preferred.

Two years' experience in a multi-disciplinary environment or Pharma R&D area is highly preferred. Experience with quality system tools are preferred (e.g. Trackwise).

Experience with Interactive Response Technologies for Clinical Trials (e.g. inventory management functionality) is preferred.

Experience with the following functions is preferred, clinical operations, logistics, quality assurance, clinical supply chain planning and drug product development. Demonstrated knowledge in Clinical Supply Distribution and Clinical Study execution /GCP is preferred.

Intermediate to advanced software skills (e.g., Microsoft Excel, SharePoint, PowerPoint) is required. Experience in a highly matrixed environment is preferred. Excellent written and verbal communication skills are required.