Clinical Research Associate Ii
1 dia 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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