Description
We are seeking a Senior Clinical Research Associate (CRA) with 4+ years of monitoring experience in Ophthalmology or Oncology to join our team in Southern California.
You will utilise your skills, knowledge, and clinical judgement to provide a high standard of care for participants in clinical trials and respond to emergency situations based upon clinical research standards.
Responsibilities
- Conduct routine monitoring and close-out of clinical sites, maintain study files, and liaise with vendors
- Ensure study staff have received 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 (CRFs)
- Complete Serious Adverse Event (SAE) reporting and process production of reports and narratives
- Independently perform CRF review and query generation and resolution
- Assist with training of new employees and coordinate designated clinical projects
Requirements
- University or college degree, or certification in a related allied health profession
- 5+ years of Clinical Monitoring experience
- Oncology experience, early phase preferred
- 30-50% overnight travel
Work Environment
- Fast-paced environment with changing priorities
- Teamwork and people skills essential
- Technology-based with data collected directly into an electronic environment
Physical Requirements
- Ability to sit for extended periods and operate a vehicle safely
- Repetitive hand movement and ability to make fast, simple, repeated movements
- Occasional crouching, stooping, and bending
- Ability to access and use computer software
- Light to moderate lifting and carrying
Salary
- Target Pay Range: $125 - $142K