Clinical Trial Coordinator

3 semanas atrás

São Paulo, Brasil MSD Brasil Tempo inteiro

Job Description Under the oversight of the line-manager, this role is responsible for comprehensive trial and site administration and involves preparing, collating, distributing and archiving clinical documents. The CTC supports clinical supply & non‑clinical supply management and ensures timely maintenance of tracking and reporting tools, as applicable. The role is critical to meeting planned Site Ready dates, including assisting finance/budgeting representatives in managing CTRAs and payments. The role will collaborate closely at the local level with COM, CRM, and CRA. Responsibilities Trial and site administration Track essential documents Ensure collation and distribution of study tools and documents Update clinical trial databases (CTMS) and trackers Document management: preparation, correspondence, archiving (eTMF) and reconciliation Execute eTMF Quality Control Plan Prepare Investigator trial file binders and obtain translations of documents Assist with budgeting, agreements and payments Develop, control, update and close‑out country and site budgets (including split site budget) Develop, negotiate, approve and maintain contracts (e.g., CTRAs) Track and report contract negotiations and maintain contract templates (in cooperation with Legal Department) Calculate and execute payments to investigators, vendors and grants Ensure adherence to financial and compliance procedures; monitor and track disclosures Maintain tracking tools and obtain/process FCPA documentation in a timely manner Qualifications Bachelor’s Degree in a relevant field Fluent in Portuguese and business‑proficient in English (verbal and written) with excellent communication skills Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines Hands‑on knowledge of Good Documentation Practices and International Conference on Harmonisation Good Clinical Practice Strong Microsoft Excel skills and good information technology skills Excellent negotiation skills, effective time management, organizational and interpersonal skills, conflict management Effective communication with external customers and ability to work independently High sense of accountability/urgency, ability to set priorities and handle multiple tasks simultaneously in a changing environment Works effectively in a matrix, multicultural environment and can establish culturally sensitive working relationships Demonstrates commitment to customer focus, both internally and externally Required Skills Accountability Analytical Problem Solving Clinical Information Systems Clinical Site Management Clinical Trial Compliance, Documentation, Monitoring, Operations, Support, Contract Management, Contract Negotiations Data Analysis, Document Management, Project Management, Regulatory Compliance, Supply Management #J-18808-Ljbffr

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