Summary

Fortrea Holdings Inc. is a leading global contract research organization (CRO) that provides comprehensive clinical development solutions to the pharmaceutical, biotechnology, and medical device industries. Headquartered in Durham, North Carolina with operations in over 90 countries, Fortrea specializes in managing all aspects of clinical trials from Phase I through IV, including clinical pharmacology and post-approval services. The company offers a wide range of services including regulatory affairs, protocol design, operational planning, patient recruitment, project management, data management, biostatistics, pharmacovigilance, and medical writing. With over 30 years of clinical research experience, Fortrea has evolved from its heritage as Covance and Labcorp into a pureplay CRO focused on delivering agile, fit-for-purpose solutions for both emerging and established life sciences companies. The company has conducted more than 5,850 clinical trials involving over 1 million subjects in the past five years, with particular expertise in oncology, central nervous system disorders, rare diseases, and cell and gene therapies.

Job description

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 provide 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.

Qualifications (Minimum Required)

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 Required)

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.

Requirements

University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution
Minimum 0 – 2+ years of experience, or an equivalent combination of education and experience
Working knowledge of ICH, RA, IRB/IEC, and other applicable regulations/guidelines
Demonstrated basic understanding of the clinical trial process
Highly proficient in Excel
IRT and IVRS familiarity preferred

Company overview

Fortrea Holdings Inc. is a leading global contract research organization (CRO) that provides comprehensive clinical development solutions to the pharmaceutical, biotechnology, and medical device industries. Headquartered in Durham, North Carolina with operations in over 90 countries, Fortrea specializes in managing all aspects of clinical trials from Phase I through IV, including clinical pharmacology and post-approval services. The company offers a wide range of services including regulatory affairs, protocol design, operational planning, patient recruitment, project management, data management, biostatistics, pharmacovigilance, and medical writing. With over 30 years of clinical research experience, Fortrea has evolved from its heritage as Covance and Labcorp into a pureplay CRO focused on delivering agile, fit-for-purpose solutions for both emerging and established life sciences companies. The company has conducted more than 5,850 clinical trials involving over 1 million subjects in the past five years, with particular expertise in oncology, central nervous system disorders, rare diseases, and cell and gene therapies.