FSP Clinical Research Associate 2 - Denver, Colorado - Oncology

About the role

Our FSP team is currently seeking a CRA 2 with 2 years of monitoring! 8-10 days on site per month being a mix of onsite and remote. Seeking candidates in the Denver, Colorado area with 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

• 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 repo11s, 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, eg. 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