Job Summary
The Clinical Research Associate II (CRA II) plays a pivotal role in overseeing the comprehensive management of clinical study sites. This includes the initiation of sites, routine monitoring activities, and ongoing management to uphold patient safety and ensure the reliability of data collected during studies.
Responsibilities
- Oversee all phases of clinical study site management.
- Facilitate site start-up processes and routine monitoring.
- Manage ongoing site operations to ensure compliance with protocols.
- Conduct independent site visits to monitor activities.
- Handle regulatory documentation and manage site-related risks.
- Ensure adherence to good clinical practice (GCP) guidelines.
Qualifications
- Bachelor’s degree in a science or healthcare-related field.
- Minimum of two years’ experience as a CRA within a contract research organization (CRO) or similar setting.
- Strong understanding of clinical trial methodologies.
- Excellent organizational and planning skills.
- Willingness and ability to travel up to 60% of the time.
