Senior CRA Client-Dedicated South Africa
- Experience Level
- Experienced (non-manager)
Senior Clinical Research Associate
Here at Syneos Health we are currently recruiting for a Senior Clinical Research Associate to be based in office Johannesburg in and work closely with one of our global pharma clients.
- Conduct all clinical site monitoring activities according to the monitoring plan and in accordance with the study timelines and company objectives. This includes but is not limited to:
Overview the overall activities of site personnel over whom there is no direct authority and motivate/influence them to meet study objectives.
Ensure quality of data submitted from study sites and assures timely submission of data. Train study site personnel on the protocol and applicable regulatory requirements.
- Facilitate Quality Assurance Audit processes as indicated.
- Report monitoring activities and study site conduct accurately and completely.
- Prepare CA and/or EC documentation, ensures submissions and/or notifications are performed as applicable.
- Manage and liaise with appropriate functions to respond to CA and/or EC questions and related follow-up.
- Negotiate investigator/ hospital agreements with stakeholders.
- Use multiple technologies to maintain open and frequent communication with internal & external customers.
The ideal candidate will need the following experience / skills to be considered:
- Minimum of 3-4 years of clinical monitoring.
- Start-up experience will be asset.
- Current in-depth knowledge and understanding of appropriate therapeutic indications as they relate to the conduct of clinical trials.
- Current in-depth knowledge of regulations governing clinical research, ICH/GCP Guidelines and applicable regulations.
- Good written and verbal communication skills. Written and verbal fluency in English.
- Previous experience with electronic data capture systems is desirable.
We have a comprehensive benefits package and offer highly competitive remuneration.
Join a game-changing company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies, INC Research and inVentiv Health, we bring together more than 22,000 clinical and commercial minds to create a better, smarter, faster way to get biopharmaceutical therapies into the hands of patients who need them most.
Why Syneos Health? Join a game-changing company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies, INC Research and inVentiv Health, we bring together more than 22,000 clinical and commercial minds to create a better, smarter, faster way to get biopharmaceutical therapies into the hands of patients who need them most. Evolve in a global company that is always looking for ways to work smarter and more efficiently as the only fully integrated Biopharmaceutical Accelerator. You'll be supported with comprehensive resources based on today's emerging technologies, data, science and knowledge - instead of practices from the past. Teaming with some of the most talented professionals in the industry, you'll gain exposure and work in a dynamic environment to over-deliver and outperform. A career with Syneos Health means your everyday work improves patients’ lives around the world.
“Preference will be given to those from previously disadvantaged groups that meets the minimum requirements of the position”