Clinical Research Coordinator

Integrated Resources Inc.; Malvern (Chester County); On-site; USD 60,000 - 90,000; Full time

Job summary

A leading staffing firm is seeking a Temperature Management Coordinator to oversee clinical supplies management during trials. The role involves ensuring compliance with GMP guidelines, managing temperature excursions, and collaborating with various stakeholders. Candidates should have solid experience in pharma R&D and strong software skills.

Qualifications

• Two years’ experience in multi-disciplinary environment or Pharma R&D preferred.
• Experience with inventory management and clinical supply chain planning is beneficial.
• Knowledge of Clinical Supply Distribution and Clinical Study execution / GCP appreciated.

Responsibilities

• Executes and manages Temperature Management for Clinical Supplies during trials.
• Manages temperature excursions, ensuring compliance with GMP guidelines.
• Collaborates across teams to resolve temperature issues and ensure customer satisfaction.

Skills

Intermediate to advanced software skills

Communication skills

Education

High School Diploma

Bachelor's Degree

Tools

Trackwise

Microsoft Excel

SharePoint

PowerPoint

Job description

Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-state area's 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.

Job Description

• The client develops treatments that improve the health and lifestyles of people worldwide. Research and development encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine.
• The client provides medicines for various health concerns across several therapeutic areas, including ADHD, cardiovascular disease, general medicine, mental health, neurology, pain management, and women’s health. Their goal is to help people live healthy lives, having produced many first-in-class medications and serving broad healthcare needs.
• The Temperature Management Coordinator is responsible for the daily execution and management of Temperature Management & Control for Clinical Supplies during clinical trials, ensuring compliance with GMP guidelines. This role follows SOPs and manages temperature excursions, ensuring prompt resolution and adherence to SOP, GMP, Quality, and Regulatory standards.
• The coordinator manages and evaluates all temperature excursions related to clinical supplies during trial execution, contributing to successful subject dosing. Acts as a single point of contact for critical business needs.
• Manages and adjusts supply dispositions via inventory systems like IVR & IWR based on temperature evaluations. Conducts issue resolution activities related to temperature excursions in clinical trials.
• Develops internal collaborations with GCDO, DPD, and Quality stakeholders to ensure resolution of temperature issues and customer satisfaction. Interfaces with Trial Managers, Drug Product Development, and Quality teams to manage temperature excursions throughout trial phases.
• Reviews and approves all Investigational Site Temperature Management Equipment Questionnaire Approvals (TMEQ) for Cold Chain IMP. Acts as a subject matter expert on temperature management requirements, including storage and monitoring capabilities. Customizes temperature out-of-range forms based on product attributes, coordinates quote requests, and manages PO setup for temperature monitoring devices.
• Collaborates with GCO stakeholders to ensure customer satisfaction and contributes to process improvement initiatives. Responsible for temperature management of clinical supplies from feasibility through trial completion.

Qualifications

• 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 is highly preferred. Experience with quality system tools like Trackwise is advantageous.
• Experience with Interactive Response Technologies for Clinical Trials (e.g., inventory management) is preferred.
• Experience in clinical operations, logistics, quality assurance, clinical supply chain planning, and drug development is preferred. Knowledge of Clinical Supply Distribution and Clinical Study execution / GCP is beneficial.

Intermediate to advanced software skills (e.g., Microsoft Excel, SharePoint, PowerPoint) are required.

• Experience in a highly matrixed environment and excellent communication skills are preferred.