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

Remote

nursing$140,000

Responsibilities

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
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

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 The important thing for us is you are comfortable working in an environment that is: Fast paced : where no deviations from the study protocol are allowed, and not meeting a timeline for even few minutes will create a quality issue.
Teamwork and people skills are essential for the study to run smoothly. Technology based .
Requirements: Ability to sit for extended periods and operate a vehicle safely.
Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
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 moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.

Our FSP team is currently seeking an Oncology Sr. CRA 2 with 5+ years of monitoring residing in Virginia/DC area.