Clinical Research Associate (CRA)

Our FSP team is currently seeking experienced CRAs with 2+ years of monitoring experience in Oncology. You will utilize 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 the study staff have received proper materials and instructions to safely enter patients into the study
• Verify that 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 against established data review guidelines
• Assist with training of 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 (e.g., nursing licensure)
• 3+ years of Clinical Monitoring experience
• 30-50% overnight travel
• Ophthalmology experience

Work Environment

• Fast-paced environment with changing priorities and constant need for teamwork and people skills
• Technology-based environment with data collected directly into an electronic environment
• Frequent travel to clients/site locations with occasional domestic and international travel

Physical Requirements

• Ability to sit for extended periods and operate a vehicle safely
• Repetitive hand movement and ability to make fast, simple, repeated movements of fingers, hands, and wrists
• Occasional crouching, stooping, and frequent bending and twisting of upper body and neck
• Ability to access and use various computer software and light to moderate lifting and carrying

Salary

• Target Pay Range: $118-$145K based on title