Christene Cloer

About Christene Cloer

Dedicated Clinical Trial Professional with extensive experience in site management, regulatory compliance, contract negotiation, and study documentation. Skilled in supporting study teams by managing essential documents, overseeing site activation, and maintaining accurate records within eTMF and CTMS systems. Proficient in coordinating IRB submissions, developing patient-facing materials, and ensuring regulatory and protocol adherence to facilitate smooth trial operations.Expert in drafting and negotiating Clinical Study Agreements (CSAs), budgets, and Confidential Disclosure Agreements (CDAs) in alignment with sponsor requirements and internal SOPs. Adept at developing investigator grants, supporting proposal processes, and maintaining contracting templates and systems to drive efficiency.Experienced in fostering collaboration among sponsors, stakeholders, and study sites, managing vendor relationships, and ensuring timely study initiation and ongoing trial management. Committed to streamlining processes, supporting investigator relationships, and ensuring compliance with regulatory and financial goals. Focused on delivering successful clinical trial execution through meticulous documentation, effective communication, and operational excellence.

Experience

1. Site Contracts & Budgets Specialist

   Lexitas Pharma Services

   Jul 2025 — Present

   Draft and negotiate site Clinical Study Agreements (CSAs) and budget templates based upon agreed-upon SOW.Develop investigator grant estimates and proposal text to support the proposal development process.Draft and negotiate Confidential Disclosure Agreements (CDAs)Utilize and maintain contract and budget templates and contracting systems, tools, processes, and training materials for selected studies according to the Scope of Work and Project Plan, within the agreed project strategy.Ensure collaboration, including communication with sponsors and stakeholders to successfully deliver the agreed project scope in compliance with sponsor requirements and/or Project Management PlanProvide specialist operational and financial contracting support to facilitate efficient business development and initiation and maintenance of clinical trials, while enabling compliance with regulatory requirements.Ensure overall contracting efficiency and adherence to project timelines and financial goals; report contracting performance metrics and out of scope contracting activities as required.Ensure accurate completion and maintenance of internal systems (CTMS), databases, tracking tools, timelines and project plan Engage in learning updated contracting processes and procedures to facilitate faster and more accurate contract negotiation, including acceptance of guidance and critiques to facilitate such learningEnsure timely completion of trainings required for this position

Education

• University of North Carolina Wilmington

  Bachelor of Applied Science - BASc, Clinical Research Coordinator