Site Contracts Specialist

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Worldwide Clinical Trials

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Worldwide Clinical Trials is a global contract research organization (CRO) that provides comprehensive clinical trial services. They specialize in supporting studies across diverse therapeutic areas such as oncology, cardiology, and rare diseases. With over 30 years of experience, Worldwide Clinical Trials emphasizes personalized support and customized solutions throughout the entire lifecycle of drug development. Their services include clinical monitoring, data management, patient recruitment, and regulatory consulting, ensuring precision and tailored attention for each clinical trial.

📋 Description

• Prepare country contract templates • Draft and send Site Agreements or any contracts associated with sites to begin negotiations • Provide site contract execution planned timelines and site negotiation status • Send items for translation, if applicable, and receive and translate items • Review study budgets and costs pertaining to contract negotiation • Negotiate contract language and budgets with each assigned site to finalization/execution • Escalate site requests outside of preapproved parameters to the Site Contracts Lead for forwarding to the Sponsor • Escalate risks and non-responsive sites to the Site Contracts Lead or internal team, as applicable • Ensure appropriate information or appendices are added to Site Agreements or related documents when equipment is provided to sites • Create donation agreements, as applicable • Review Site Agreements or associated contracts for completeness and accuracy • Finalize contracts and budgets with sites • Perform quality checks of Site Agreements or associated documents before the signature process begins • Provide draft or signed contracts and budgets to the regulatory team for submission purposes when requested • Liaise with Worldwide Clinical Trials Legal Department, Data Privacy team, study teams, Sponsors, sites, investigators, and others as needed • Facilitate contract signatures by Worldwide Clinical Trials, when applicable • Distribute fully executed Site Agreements or associated documents to sites, eTMF, payment team, Sponsor, and post to internal SharePoint, as applicable • Negotiate Site Agreement amendment language and budgets with sites • Create termination letters or other related documents and send to sites for signature, as applicable • Maintain tracking tools with live, real-time, or regular updates for functional activities • Prioritize effectively and respond to urgent requests within the internal team or from Sponsors • Perform other duties as assigned.

🎯 Requirements

• Bachelor’s degree or equivalent in business administration, finance, science, or a related field • 1 to 3 years of experience in the Contract Research Organization, pharmaceutical, or clinical research industry, working with investigator/site contracts or a related legal field • Excellent verbal and written English language skills • Proficiency with Microsoft Word, Excel, and Outlook • Knowledge and understanding of International Council for Harmonization (ICH) and Good Clinical Practice (GCP) guidelines, as well as local country legislation and regulatory requirements related to clinical trials

🏖️ Benefits

• Health insurance • Flexible working hours • Professional development opportunities