Description
We are seeking an Ophthalmology Sr. CRA 2 to join our FSP team. As a Senior Clinical Research Associate, you will utilise your skills, knowledge, and clinical judgement to provide high-quality care for participants in clinical trials and respond to emergency situations based on clinical research standards.
Responsibilities
- Conduct routine monitoring and close-out of clinical sites, maintaining study files, and liaising with vendors
- Ensure study staff receive proper materials and instructions to safely enter patients into the study
- Verify informed consent procedures and protocol requirements are adhered to according to regulatory requirements
- Monitor data for missing or implausible data and ensure the integrity of data submitted on Case Report Forms
- Complete Serious Adverse Event reporting and process production of reports and narratives
- Independently perform CRF review, query generation, and resolution against established data review guidelines
- Assist with training new employees and coordinate designated clinical projects as a Local Project Coordinator
Requirements
- University or college degree, or certification in a related allied health profession
- 5+ years of Clinical Monitoring experience
- Oncology experience, preferably in early-phase studies
- Ability to travel 30-50% of the time, potentially overnight
Work Environment
- Fast-paced environment with changing priorities and constant adaptation
- Teamwork and people skills essential for smooth study execution
- Technology-based, collecting data directly into an electronic environment
Physical Requirements
- Ability to sit for extended periods, operate a vehicle safely, and perform repetitive hand movements
- Occasional crouching, stooping, bending, and twisting of upper body and neck
- Light to moderate lifting and carrying of objects up to 15-20 lbs
Salary: $125 - $140K