FSP Sr. Clinical Research Associate II - Colorado, Nevada, Utah - Oncology

About the role

Our FSP team is currently seeking an Oncology Sr. CRA 2 with 5+ years of monitoring residing in the Colorado, Nevada or Utah region. 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. Work is performed in an office environment with exposure to electrical office equipment, frequent travel to clients/site locations with occasional domestic and international travel. Physical requirements include ability to sit for extended periods, operate a vehicle safely, repetitive hand movement, occasional crouching/stooping with frequent bending/twisting, ability to access and use various computer software, light to moderate lifting up to 15-20 lbs, regular attendance, varied hours may be required.

Responsibilities

• Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned
• Responsible for all aspects of site management as prescribed in the project plans
• General On-Site Monitoring:
  • Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study
  • Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements
  • Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document
  • Monitor data for missing or implausible data
• Responsible for all aspects of registry management as prescribed in the project plans
• Undertake feasibility work when requested
• Complete Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
• Independently perform CRF review; query generation and resolution against established data review guidelines on Fortrea or client data management systems as assigned by management
• Assist with training of new employees, e.g., co-monitoring
• Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable) and may act as a local client contact as assigned
• Perform other duties as assigned by management

Requirements

• University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g. nursing licensure)
• 5+ years of Clinical Monitoring experience
• Oncology experience, early phase preferred
• 30-50% overnight travel

Pay

Target Pay Range: $125 - $140K