Clinical Research Associate Ii
4 semanas atrás
**Join Our Team as a Clinical Research Associate II**Are you an experienced clinical research professional ready to take the next step in your career? We are seeking a **Clinical Research Associate II**to join our team. In this advanced role, you will develop strong site relationships and be responsible for effective site management throughout all phases of clinical research trials.**Key Responsibilities**:- Develop and maintain strong relationships with study sites to ensure continuity and success throughout the trial phases.- Perform clinical study site management and monitoring activities in compliance with ICH-GCP, Sponsor SOPs, local laws, and regulations.- Gain an in-depth understanding of study protocols and related procedures.- Coordinate and manage various tasks in collaboration with other sponsor roles to achieve “Site Ready” status.- Participate in site selection and validation activities, providing valuable input.- Conduct comprehensive site visits, including initiation, monitoring, and close-out visits, and document findings accurately and timely.- Collect, review, and manage required regulatory documentation for study start-up, maintenance, and close-out phases.- Communicate effectively with investigators and site staff regarding protocol conduct, recruitment, retention, protocol deviations, and overall site performance.- Identify, assess, and resolve site performance, quality, or compliance issues in collaboration with stakeholders.- Work in partnership with internal and external teams to support assigned sites.- Manage and maintain information in Clinical Trial Management Systems (CTMS), electronic Trial Master Files (eTMF), and other relevant systems.- Act as a Subject Matter Expert (SME) within the CRA team, mentoring colleagues and sharing best practices.- Support and/or lead audit and inspection activities as required.- Perform co-monitoring visits when appropriate.- Contribute to the identification of new potential sites and assist in developing their clinical research capabilities.**Main Requirements**:- ** Education**:Bachelors degree required, with emphasis in life sciences, biology, or related fields.- ** Experience**: Previous experience in the role of Clinical Research Associate is essential.- ** Languages**: Fluent in Portuguese and possess advanced English (verbal and written).- Understanding of clinical research processes, phases of clinical trials, and current ICH Good Clinical Practice & country-specific clinical research laws and guidelines.- Hands-on knowledge of Good Documentation Practices.- Developing skills in site management, including performance management and patient recruitment.- Strong monitoring skills complemented by independent professional judgment.- Ability to perform root cause analysis and implement preventive and corrective actions.- Work Environment: Ability to work effectively in a matrix multicultural environment.ClinicalTrialsBR**Search Firm Representatives Please Read Carefully****Employee Status**:Regular**Relocation**:No relocation**VISA Sponsorship**:No**Travel Requirements**:75%**Flexible Work Arrangements**:Not Applicable**Shift**:Not Indicated**Valid Driving License**:No**Hazardous Material(s)**:n/a**Job Posting End Date**:05/6/2025**Requisition ID**:R
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Clinical Research Associate II
2 semanas atrás
São Paulo, Brasil beBeeClinicalResearch Tempo inteiroJob Title: Clinical Research Associate II Clinical Research Associate II (CRA II) Location: São Paulo - São Paulo - Brazil Work Model: Hybrid (Vila Olimpia) or Remote for non-São Paulo candidates. We welcome applications from individuals residing in the Southern and Southeastern regions. About Us Intrials is a pioneering company known for its innovative...
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Clinical Research Associate II
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São Paulo, Brasil MSD Malaysia Tempo inteiroClinical Research Associate II page is loaded## Clinical Research Associate IIremote type: Remotelocations: BRA - Sao Paulo - Sao Paulo (Torre Z)time type: Full timeposted on: Posted Todaytime left to apply: End Date: January 21, 2026 (5 days left to apply)job requisition id: R Job Description**Clinical Research Associate II**As a Clinical Research Associate...
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Clinical Research Associate Ii
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São Paulo, Brasil ICON Tempo inteiroClinical Research Associate ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are currently seeking a Clinical Research Associate II to join our...