Senior CRA Client-Dedicated South Africa
- Experience Level
- Experienced (non-manager)
Here at Syneos Health we are currently recruiting for a Senior Clinical Research Associate to work with one of the largest and most successful Pharmaceutical companies in the world.
• Identifies, evaluates, and recommends potential investigators/sites on an on-going to assist in the placement of planned clinical studies with qualified investigators.
• Critically reviews and analyzes site activities through frequent visits and contacts to monitor study sites following the monitoring plan and applicable BMS SOPs, to assure compliance with the protocol, ICH and/or FDA GCP Guidelines and other local regulations.
• Ensures quality of data submitted from study sites and assures timely submission of data.
• Ensures safety and protection of study subjects according to the monitoring plan, BMS SOPs, and ICH and/or FDA GCP Guidelines.
• Supervises overall activities of site personnel over whom there is no direct authority and motivates /influences them to meet study objectives.
• Anticipates and proactively solves study site problems/issues as they occur. Initiates, recommends and communicates corrective actions as needed.
• Ensures documented follow-up to all outstanding issues, within the scope of this position profile.
• Appropriately escalates serious or outstanding issues to line manager and project team members.
• Proactively communicates and escalates with all internal and external stakeholders any issues identified at study sites while developing the corresponding mitigation strategies and recommended approach.
• Prepares and submits written reports, both monitoring and administrative, in a timely, accurate, concise and objective manner.
The ideal candidate will need the following experience / skills to be considered:
• Minimum of a Bachelor of Science degree in a health related field with a minimum of 2-3 years clinical research experience
· Previous proven experience in monitoring Oncology studies.
• Demonstrated success in working independently
• Strong communication and leadership skills
• Ability to work independently and travel up to 50% of time.
· Fluent in English.
If you have the required experience for this position and are eligible to work in the required location then please apply by CV.
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.