Sr. CRA , FSP - Oncology - West Coast

Benefits

Qualifications

• •University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure)
• •4+ years of clinical monitoring experience
• •Oncology experience required
• •60‑70% overnight travel
• •Ability to sit for extended periods and operate a vehicle safely
• •Repetitive hand movement of both hands with ability to make fast, simple, repeated movements of fingers, hands, and wrists
• •Occasional crouching, stooping, frequent bending and twisting of upper body and neck
• •Ability to access and use a variety of computer software developed both in‑house and off‑the‑shelf
• •Light to moderate lifting and carrying (or otherwise moving), objects including luggage and laptop computer with a maximum lift of 15‑20 lbs
• •Regular and consistent attendance
• •Varied hours may be required
• •8 more items(s)

Responsibilities

• •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
• •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 study staff have received proper materials and instructions to safely enter patients into the study
• •Ensure protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to applicable regulatory requirements
• •Ensure integrity of the data submitted on CRFs or other data collection tools by carefully monitoring source documents 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 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
• •Work performed in an office environment with exposure to electrical office equipment
• •Frequent travel to client/site locations with occasional travel both domestic and international
• •12 more items(s)