As a leading contract research organization (CRO), Labcorp Drug Development provides comprehensive drug development solutions for a range of industries. Our services cover the preclinical, clinical and post-market phases of drug development, the product life cycles for medical device and diagnostics and development services paired with regulatory support for the chemical testing and crop protection industries.

Labcorp Drug Development is a global leader in nonclinical safety assessment, clinical trial testing and clinical trial management services. Our unique perspectives are based on decades of scientific, medical and regulatory expertise.

We are recruiting for our Site Readiness business in Poland and are currently seeking to hire a Study Start-up Specialist who will work with multiple sponsors. This is a permanent and full-time position.

Responsibilities include but are not limited to:

• Primary contact with assigned investigative sites during site start-up activities and maintenance with responsibility for collection of the required investigator and essential documents for a study
• Ensure EC/IRB and any other local applications are made within the timelines agreed with project management and Start-up team and that documentation meets the specifications required by applicable regulations and sponsor
• Collect, track and perform a quality review of all essential & investigator documents required for effective and compliant study site activation and maintenance
• Ensure that all assigned maintenance and Start-up activities are on track and in accordance with client expectations, ICH/GCP, SOPs, budget, quality and applicable laws and guidelines
• Serve as primary contact for investigative sites and ensure documents required are collected in a timely manner
• Proactively manage sites to ensure timely site activation and escalate study issues appropriately and in a timely fashion
• When needed, assist in preparation of Site Activation project specific plans and provide accurate projections and timelines to study teams and customize country and site specific patient informed consent forms for compliance with local requirements and protocol
• Proactively resolve informed consent issues and other potential difficulties with study sites
• Prepare submissions to IRB/IEC and liaise with applicable IRB/IEC and/or regulatory authorities (if applicable) regarding submission/ approval issues
• Support or perform the negotiation of site contracts and budgets with sites, if applicable and track progress of contract and budget milestones/developments, intervening and escalating as appropriate

Job Requirements:

• University/College degree (life science preferred) and strong working knowledge of the ICH guidelines and FDA, IRB/IEC regulations
• Experience in clinical development or start up/regulatory process
• Working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines; familiarity with investigator start-up documents, EC/RA submission sand contract/budgets negotiation process; previous interaction with operational project teams and investigative sites
• Demonstrated understanding of research protocol requirements and proven ability to communicate them/educate others about them
• Fluency in Polish and English

Labcorp is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant's race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status.

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