Clinical Trial Assistant

Clinical Trial Assistant

Integrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and business more efficiently and effectively. Since launching in 1996, IRI has attracted, assembled and retained key employees who are experts in their fields. This has helped us expand into new sectors and steadily grow.

Job Description

This individual contributor is responsible for the management of clinical supplies during the execution phase of clinical trials consistent with GMP guidelines with a specific focus on Temperature Management & Control of Clinical Supplies.

Description of the Role

Responsible for management of 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 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

Conduct issue resolution activities for the temperature excursion supply aspects of the clinical trials

Develop strong internal collaboration with GCO, DPD, and Quality stakeholders to ensure 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 Pharma R&D for all phases of clinical trials

Review and approval of all Investigational Site Temperature Management Equipment Questionnaire Approvals (TMEQ) for Cold Chain IMP

Act as subject matter experts for temperature management requirements including storage and monitoring capabilities

Customizing protocol specific temperature out-of-range forms based on product attributes

Coordinating quote request and 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 business process improvement initiatives.

Focus and Scope

Responsible for the Temperature Management & Control of all clinical supplies from feasibility throughout trial execution

Critical Experiences Required

A university/bachelor's degree (or equivalent experience) is required. Generally, requires 2+ years related experience.

Experience with quality system tools preferred (e.g. Trackwise)

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

Experience with the following functions preferred: clinical operations, logistics, quality assurance, clinical supply chain planning, drug product development

Demonstrated knowledge in the following areas:

Clinical Supply Distribution

Clinical Study Execution/GCP

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

Experience in a highly matrixed environment (preferred)

Critical Competencies:

Very strong data analysis and problem solving experience

Highly organized with strong attention to detail

Extreme sense of urgency for the tasks at hand, including ability to drive resolution with minimal management oversight

Excellent written and verbal communication skills

Task oriented (repetitive process)

Strong quality management skills

Strong strategic thinking skills

Excellent problem solving and decision making skills

Strong cross-functional coordination skills

Additional Information

Feel free to forward my email to your friends/colleagues who might be available. We do offer referral Bonus.

Thank you.

Kind Regards,

Harris Kaushik

Clinical Recruiter

Integrated Resources, Inc.

IT Life Sciences Allied Healthcare CRO

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