Clinical Research Associate Ii

3 semanas atrás

São Paulo, São Paulo, Brasil MSD Tempo inteiro
**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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