Clinical Research Associate
4 days ago
**JOB DESCRIPTION**:
**Clinical Research Associate - Client-dedicated - South Africa**
**Who is PPD Clinical Research Services?**
PPD is a leading global contract research organization. Our purpose is to improve health. Our mission is to help customers deliver life-changing therapies. Our strategy is to bend the cost and time curve of drug development and optimize value for our customers. PPD is now part of Thermo Fisher Scientific. As the world leader in serving science, our Mission is to enable our customers to make the world healthier, cleaner and safer. We are excited about the opportunities this combination brings to enhance our comprehensive end-to-end offering, enabling customers to move rapidly from scientific idea to approved medicine
**The PPD FSP Solution**:
PPD's Functional Service Provider division partner with and serve as an extension of our PPD team, supporting our customers key functions. We cover customer needs on every level, allowing them to do more with less, with an uncompromising commitment to quality. We deploy the same top-tier talent in ALL engagement models. Exceptionally trained, rigorously supported and technologically empowered to help customers manage capacity and set programs up for success.
Joining within our PPD FSP functional area, allows you to join the renowned PPD CRO and still gain invaluable client dedicated experience.
**Job Profile**:
The Clinical Research Associate (CRA) performs and coordinates all aspects of the clinical monitoring and site management process in accordance with ICH GCP, FDA guidelines, local regulations and Sponsor’s SOPs. The CRA conducts site visits to assess protocol and regulatory compliance and manages required documentation and ensures that data will pass international quality assurance audits. They also develop collaborative relationships with investigational sites. You will be fully integrated into the client's systems, using their SOPs.
**Job Qualification**:
**Education and Experience**:
- Medical, pharmaceutical or other **life-science** related degree
- **At least 1 year of independent monitoring experience** in a CRO, pharmaceutical or biotech company
**Additional Requirements**:
- Demonstrated clinical trial monitoring skills
- In-depth understanding of ICH/GCP guidelines
- Excellent standard of verbal and written communication skills in English
- Highly organized with strong attention to detail and deadlines
- Advanced skills across all of the Microsoft packages
- Willingness to travel in South Africa and Africa
**Our 4i values**:
- Integrity - Innovation - Intensity - Involvement
**Work Environment Requirements**:
PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive.
PPD® FSP: People Who Deliver | PPD Careers - Read about PPD employee experiences
- LI-MP1
**Diversity Statement**:
- PPD is proud to be an affirmative action employer that values diversity as a strength and fosters an environment of mutual respect. PPD is committed to providing equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or status within any other protected group.
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