Sr. CRA II, Oncology, FSP - Virginia/DC

Responsibilities

• Utilize skills, knowledge, and clinical judgement to provide high standard of care for participants in clinical trials and respond to emergency situations based on clinical research standards.
• 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.
• Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study.
• Verify that informed consent procedures and protocol requirements are adhered to according to applicable regulatory requirements.
• Maintain the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by carefully reviewing source documents.
• Monitor data for missing or implausible data.
• 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.
• Absorb and train 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.
• 40-50% overnight travel.