Clinical Research Associate

1 semana atrás

São Paulo, Brasil Parexel Tempo inteiro
The Clinical Research Associate is the clinical sites’ direct point of contact and accountable for managing site quality and delivery from site identification through close-out. The aim of this role is to build the relationship with the site, to be the sole position accountable for the site performance, including driving the site successfully to initiation, the development of a robust patient recruitment strategy, setting up a system, assessing compliance with regulations and the site’s capability to comply with the study needs and recruitment expectations, and problem solving to address and resolve site issues.
The Clinical Research Associate might be asked to complete tasks on behalf of the Clinical Operations Leader after receiving appropriate training.
Where available an “initiation Clinical Research Associate“ (iCRA) specializing in Pre SIV activities will be
assigned & accountable for managing and driving the strategy for the Pre SIV / startup tasks of the study. The iCRA) also support protocol amendments if applicable.
**Skills**:
- Sound problem solving skills.
- Able to take initiative and work independently, and to proactively seek guidance when necessary.
- Advance presentation skills.
- Client focused approach to work.
- Ability to interact professionally within a client organization.
- Flexible attitude with respect to work assignments and new learning.
- Ability to prioritize multiple tasks and achieve project timelines; utilizing strong analytical skills to make decision autonomously due to the unpredictable nature of the issues that arise.
- Willingness to work in a matrix environment and to value the importance of teamwork.
- Strong computer skills including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS), and MS-Office products such as Excel and Word.
- Strong interpersonal, verbal, and written communication skills.
- Sense of urgency in completing assigned tasks and ability to assist others to meet study/country deliverables and preserving patient safety.
- Effective time management in order to meet study needs, team objectives, and department goals.
- Developing ability to work across cultures.
- Shows commitment to and performs consistently high-quality work.
- Ability to successfully work in a (‘virtual’) team environment.
- Consulting Skills
- Great attention to detail.
- Able to accommodate extensive travel time requirements, according to tasks allocation/phase of the study assigned.
- Holds a driver’s license where required.
**Knowledge and Experience**:
- Site Management experience or equivalent experience in clinical research, with understanding of clinical trials methodology and terminology
**Education**:
- Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or other equivalent experience
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