Regulatory Assistant (Crossroads) at Desmond Tutu Health Foundation

Job Description
Requirements

• Matric and or diploma in a health-related field
• At least two (2) years’ clinical research experience
• Excellent computer proficiency: Microsoft Outlook
• Ability to solve problems analytically and creatively
• Excellent organization, coordinating and administrative skills
• Ability to work under pressure
• Driven and fully committed to achieving results
• Excellent written and oral communication
• Good work standards
• Client Service
• Decision making
• Technical knowledge and skills
• Attention to detail
• Interpersonal skills  

Advantageous:

• Regulatory experience in a Clinical research environment

 Responsibilities:

• Assist Regulatory Manager with submission of appropriate documentation for UCT Ethics Committee (serious adverse event reports, 6-monthly project updates, continuing review of research activities)
• Assist Regulatory Manager with submission of documentation to Medicines Control Council (6-monthly reports)
• Submission of other regulatory documents
• Gather and file staff regulatory documents
• Ensure all CVs are formatted correctly and updated annually (± 50 staff)
• Ensure all staff have current GCP and HSP training certification on file
• Ensure new staff complete study-specific training
• Ensure that site organograms, staff signature logs, delegation of duty logs, job descriptions are up to date and filed 
• Maintenance of regulatory binders
• Assist study team in preparing for new studies
• File all ethics correspondence
• File protocol activation documentation