Clinical Trial Assistant

divh2Clinical Trial Assistant/h2pIntegrated 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./ph3Job Description/h3pThis 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./ppDescription of the Role/ppResponsible 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 RD for all phases of clinical trials/ppAct as a single point of contact accountable for the business critical need/ppManage and adjust supply dispositions via inventory systems including IVR IWR/ppConduct issue resolution activities for the temperature excursion supply aspects of the clinical trials/ppDevelop strong internal collaboration with GCO, DPD, and Quality stakeholders to ensure TOR resolution and overall customer satisfaction/ppInterface with Global Trial Managers, Trial Supply Managers, Drug Product Development, and Quality to manage trial supply temperature excursions/ppResponsible for execution of Temperature Monitoring Coordinator role during trial feasibility and throughout trial execution driving robust temperature management within Pharma RD for all phases of clinical trials/ppReview and approval of all Investigational Site Temperature Management Equipment Questionnaire Approvals (TMEQ) for Cold Chain IMP/ppAct as subject matter experts for temperature management requirements including storage and monitoring capabilities/ppCustomizing protocol specific temperature out-of-range forms based on product attributes/ppCoordinating quote request and PO setup process to centrally source temperature monitoring devices/ppDevelop strong internal collaboration with GCO stakeholders to ensure customer satisfaction/ppPartner 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/ppSupports business process improvement initiatives./ppFocus and Scope/ppResponsible for the Temperature Management Control of all clinical supplies from feasibility throughout trial execution/ppCritical Experiences Required/pp A university/bachelors degree (or equivalent experience) is required. Generally, requires 2+ years related experience./ppExperience with quality system tools preferred (e.g. Trackwise)/ppExperience with Interactive Response Technologies for Clinical Trials (e.g. inventory management functionality)/ppExperience with the following functions preferred: clinical operations, logistics, quality assurance, clinical supply chain planning, drug product development/ppDemonstrated knowledge in the following areas:/ppClinical Supply Distribution/ppClinical Study Execution/GCP/ppIntermediate to advanced software skills (e.g., Microsoft Excel, SharePoint, PowerPoint)/ppExperience in a highly matrixed environment (preferred)/ppCritical Competencies:/ppVery strong data analysis and problem solving experience/ppHighly organized with strong attention to detail/ppExtreme sense of urgency for the tasks at hand, including ability to drive resolution with minimal management oversight/ppExcellent written and verbal communication skills/ppTask oriented (repetitive process)/ppStrong quality management skills/ppStrong strategic thinking skills/ppExcellent problem solving and decision making skills/ppStrong cross-functional coordination skills/ph3Additional Information/h3pFeel free to forward my email to your friends/colleagues who might be available. We do offer referral Bonus./ppThank you./ppKind Regards,/ppHarris Kaushik/ppClinical Recruiter/ppIntegrated Resources, Inc./ppIT Life Sciences Allied Healthcare CRO/ppDIRECT # - View phone number on click.appcast.io/ppGold Seal JCAHO Certified for Health Care Staffing/ppINC 5 0 0 0 s FASTEST GROWING, PRIVATELY HELD COMPANIES (8th Year in a Row)/p/div