IQVIA is seeking Study Start-Up Clinical Research Associates to join our Sponsor Dedicated teams to manage site selections and study-specific start-up activities for Phase I-IV trials
Requirements
- Experience in Study Start-Up
- At least 8 months of on-site monitoring experience
- Knowledge of ICH/GCP, local regulations and SOPs
- Ability to implement innovative and efficient processes aligned with the sponsor strategy
- Knowledge of clinical research services and healthcare intelligence
- Familiarity with TMF documents and inspection readiness
- Understanding of financial standards, prevailing legislation, and Health Authority requirements
Responsibilities
- Conducts site selection visits, verifies site eligibility for a specific study
- Acts as the main contact for trial sites during site selection, study start-up and IRB/IEC and HA submission preparation
- Ensures that milestones (KPIs) and time schedule for study start-up are met as planned
- Facilitates the preparation and collection of site and country level documents
- Collects submission-related site-specific documents for all relevant site personnel within agreed timelines
- Supports the SSU Manager with preparation of country-specific documents, e.g., ICF, patient facing materials, etc.
- Updates all systems until site Green Light on an ongoing basis
Other
- Travel up to 70-80% required
- Bachelor's degree or equivalent experience
- Ability to work collaboratively with cross-functional teams
- Strong communication and interpersonal skills
- Ability to work in a fast-paced environment with multiple priorities and deadlines
