Description
We are seeking a Freelance Senior CRA to work within a large-scale, fast-paced environment alongside a close-knit team of highly qualified CRAs to identify, select, initiate and close-out investigational sites for clinical studies in phases II – IV, ensuring adherence to applicable regulations and principles of ICH-GCP.
Responsibilities:
- Work independently and actively to coordinate activities to set up and monitor a study, completing accurate study status reports and maintaining study documentation
- Submit protocol, consent documents for ethics/IRB approval and assist in preparing regulatory submissions as requested
- Participate in preparing and reviewing study documentation and feasibility studies for new proposals as required
- Balance sponsor generated queries efficiently and be responsible for study cost-effectiveness
- Depending on level of experience, assist in training and mentoring less expert CRA's and/or lead CRA's working on international projects
Requirements:
- 18 months+ of monitoring experience in phase I-III trials as a CRA
- Knowledge of ICG GCP guidelines and expertise to review and evaluate medical data
- Excellent written and verbal communication in English
- Ability to produce accurate work to tight deadlines within a pressurized environment
- Valid driving license
- Travel at least 60% of the time (international and domestic)
Benefits:
- Competitive salary packages
- Annual bonuses reflecting delivery of performance goals
- Range of health-related benefits to employees and their families
- Competitive retirement plans
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others