Initiation Clinical Research Associate
hace 3 días
Everything we do has the potential to impact patient lives, and our Clinical Research Associates (CRAs) take their work seriously, demonstrate empathy, and act with heart. They also perform with urgency, navigating our streamlined clinical operating model to drive effectiveness, reduce handoffs and increase employee, client and site satisfaction.
As a CRA at Parexel, you‘ll be joining a team with a wide variety of experiences and knowledge. We’re looking for people like you to take the initiative to do things better and smarter—people who want to grow personally and professionally. We recognize and uphold the importance of all people, the way we do things, our quest for innovation, and most importantly, our patients. Explore opportunities within our core Clinical Development, Biotech, or Functional Service Provider (FSP) teams below.
- Full Time
- Travel: Yes
- Glassdoor Reviews and Company Rating
**Success Profile**:
Check out the top traits we’re looking for and see if you have the right mix.
- Innovative
- Problem-Solver
- Communicator
- Tech-Savvy
- Confident
- Independent
**Rewards**:
- **Global Impact**:
We are one truly global team working together to propel each client´s journey ahead faster.
- **Balance**:
We value work-life balance. We try and keep regular hours and an emphasis on life outside the office.
- **Collaboration**:
- **Freedom**:
The ability to innovate, ask “what if” and try new solutions without fear of failure.
- **Variety**:
Opportunities to work on multiple accounts - never boring
- **Compensation**:
Competitive salaries and bonus structure based on individual metrics.
Working from partially from home and in our office in Buenos Aires, as an Initiation Clinical Research Associate (ICRA) you will be the direct point of contact with assigned sites and accountable for quality and delivery during the start-up phase. Duties will include Preparation, negotiation, and facilitation of Confidentiality Agreements (CDA), Clinical Site Agreements (CSAs) and any amendments, Informed Consent Forms (ICF); Conduct remote Qualification Visits (QVs), Update and maintain appropriate Clinical Trial Management systems (CTMS) in a timely manner.
To be considered for this opportunity you must have clinical trials experience as a CRA, study nurse or site coordinator ideally with a university degree in a health-related discipline. Understanding of GCP and relevant regulations plus knowledge of submissions and ICF customizations is expected. This is a virtual team environment and your strong interpersonal and communication skills will help you to succeed. Fluency in English is required.
**Qualifications**:
- Significant regulatory and/or site experience in clinical trials
- Educated to degree level preferred (biological science, pharmacy or other health-related discipline preferred), nursing or other relevant qualification/experience
- Sound awareness of all relevant regulations, including GCP
- Fluency in English is required
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