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Responsibilities
- Acts as primary site contact and site manager throughout all phases of a clinical research study
- Develops strong site relationships and ensures continuity through all trial phases
- Performs site management and monitoring activities in compliance with ICH-GCP and sponsor SOPs
- Coordinates tasks with sponsor roles to achieve Site Ready
- Participates and provides input on site selection and validation activities
- Conducts remote and on-site monitoring activities to ensure data accuracy and subject safety
- Collects, reviews, and monitors required regulatory documentation
- Communicates with investigators and site staff on protocol conduct and site performance
- Identifies and resolves site performance and compliance issues
- Manages information and documentation in CTMS, eTMF, and other systems
Requirements
- B.A./B.S. preferred with strong emphasis in science or biology
- Min. 2 years of direct monitoring experience
- Fluent in local languages and English, with excellent communication skills
- Strong understanding of clinical research, phases of trials, and GCP/ICH guidelines
- Valid Category B driver’s license
- Proven skills in site management and patient recruitment
- Experience with conducting site motivational visits
- Good IT skills and ability to adapt to new applications
Benefits
- 1 additional day off for your birthday
- Private medical healthcare
- Loyalty Bonus Program with awards or extra paid time off
- Additional days off during the end of the year
- Employee referral system
- Onboarding process and induction training for sector knowledge and skills
- Access to the latest technology and advanced equipment
- Mentoring and training programs on clinical trials, therapeutic areas, and skills
