H-1B Visa Clinical Trial Coordinator Jobs

INTRODUCTION

Fortrea is hiring a Clinical Trial Coordinator - Drug Reconciliation! Seeking someone experienced in drug reconciliation, documentation oversight, quality checks and supply tracking. Should be highly proficient in Excel and preferably have IRT and IVRS familiarity.

Job Overview:

• Provides day-to-day support for drug reconciliation for both blinded and unblinded studies.
• Serves as point of contact and key escalation point for Clinical Operations teams for all clinical drug supply reconciliation issues.
• Creates and manages excel trackers for each study to reconcile drug for each site.
• Reviews all the documentation needed for drug reconciliation such as clinical supply return forms, drug accountability logs and drug destruction forms.
• Routinely collaborates with internal Clinical Operations teams and updates Clinical Research Manager responsible for the study.
• Communicates with blinded and unblinded CRA to manage drug reconciliation process. Works closely with monitoring excellence teams.
• Routinely identifies risks and assists with corrective action plans to streamline the process.
• Assists in reviewing IRT/IVRS shipping history to manage the drug reconciliation process.
• In cases where an IRT/IVRS system is not available for a trial, provides logistics support and oversight of clinical supply.
• Maintains supply inventory tracking records where electronic versions are not available and provides training to CRA for drug reconciliation documentation and process.
• Creates database in SharePoint for CRA to enter documentation after final drug return occurs to maintain record for drug reconciliation.
• Reviews and uploads clinical supply return forms from Fisher drug depot in eTMF. Conducts quality checks and communicates with CRA to provide corrected documents and sends back to Fisher to have documents stamped.
• Maintains yearly check in eTMF for drug reconciliation documents.
• Conducts weekly and monthly calls with each study Clinical Research Manager to provide updates on study status and provide support to CRAs in case site has incomplete documentation.
• Provides quality check to CTMS and Veeva vault documentation.
• Creates country memo after the drug reconciliation is finalized and all the documentation is reviewed and filed in eTMF.

BASIC QUALIFICATIONS

• University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology).
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

Experience

• Minimum 0 – 2 + years of experience, or an equivalent combination of education and experience to successfully perform the key responsibilities of the job.
• Working knowledge of ICH, RA, IRB/IEC, and other applicable regulations/guidelines.
• Demonstrated basic understanding of the clinical trial process.

PHYSICAL DEMANDS/WORK ENVIRONMENT

• Ability to sit for extended periods and operate a vehicle safely.
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
• Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
• Regular and consistent attendance.
• Varied hours may be required.
• Target Pay Range: $55-65K (hourly role)

Learn more about our EEO & Accommodations request here.