Clinical Trial Assistant

Integrated Resources Inc.; Malvern (Chester County); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Referral Bonus

Job summary

A leading company in clinical resource management seeks an individual contributor for clinical supply temperature management during trials. The role involves ensuring compliance with GMP guidelines, managing temperature excursions, and collaborating with various stakeholders. Candidates should have a bachelor's degree, substantial experience, and strong analytical skills.

Qualifications

• Requires 2+ years of related experience.
• Experience with Interactive Response Technologies.
• Strong organizational skills and urgent task management.

Responsibilities

• Manage temperature excursions during clinical trials.
• Collaborate with various stakeholders for trial supply management.
• Ensure compliance with SOP, GMP, and regulatory guidelines.

Skills

Quality Management

Data Analysis

Problem Solving

Attention to Detail

Cross-functional Coordination

Education

University/Bachelor's degree

Tools

Trackwise

Microsoft Excel

SharePoint

PowerPoint

Job description

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

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 matrixes environment (preferred)

•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,

Clinical Recruiter

Integrated Resources , Inc.

DIRECT # - (650)-399-0891

Gold Seal JCAHO Certified for Health Care Staffing

“INC 5 0 0 0 ’s FASTEST GROWING, PRIVATELY HELD COMPANIES” (8th Year in a Row)