Source Documentation Specialist at Synexus Clinical Research Ltd

Job Summary

Are you looking to play an integral role in the future of medicine across the globe? If so, this may be the opportunity for you! We are currently looking to attract a Source Documentation Specialist. In this role you can be home-based or working from one of our offices in South Africa. As a Source Documentation Specialist, you will assist with the creation, completion, and maintenance of clinical trial source documents. This includes the preparation of documents and assisting with responses to site staff members. This is a global position communicating with all AES countries worldwide.

Role Responsibility
Key roles and responsibilities of the Source Documentation Specialist are:

• Create, complete, maintain source documents for clinical studies
• Review study protocols and utilize sponsor provided materials and other resources to include all essential elements of protocol into source documents
• Manage the version control of source documents
• Liaise with other functional/departmental managers/ Investigators to understand all necessary aspects and needs of source documents & criteria, and to ensure it meets requirements
• Distribute source documentation to site staff efficiently and in timelines
• Ensure sites are using the correct source document
• May be required to provide initial and ongoing training to site staff in the completion of documents
• Ensure all source documents are prepared in accordance with GCP, ICH, FDA and other applicable regulatory guidelines
• Ensure quality and compliance by following established SOPs, ICH/GCP, study-specific manuals and other applicable regulatory requirements.

Ideal Candidate
To be considered for this challenging and exciting opportunity you will need the following skills and experience:

• At least 1 year of clinical research experience, or an equivalent combination of education and experience
• Knowledge of medical terminology, clinical research protocols and source documentation
• Detail orientated and inquisitive
• Ability to work independently
• Ability to work in a busy interactive environment and to perform tasks accurately and quickly
• Extremely organised with strong time management skills
• Strong computer and typing skills, strong proficiency in Microsoft Office programs (Outlook, Word, Excel) and Web applications and able to type proficiently (35+ wpm)
• Ability to use software to develop organized information sources and to provide a variety of reports
• Fluent English

Package Description

• Competitive salary and benefits; interesting job in a multinational company; open and friendly organizational culture; opportunity for training and professional development in the area of clinical trials.