As a leading full-service global CRO, we work to create solutions that advance new treatments from discovery to reality.
Site Contracts Specialist
Location
Argentina
Posted
2 days ago
Salary
0
Seniority
Junior
Job Description
Site Contracts Specialist
Worldwide Clinical Trials
• 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.
Job 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
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