Oncology - CAR-T - CRAs & Sr. CRAs - Remote US

Fortrea•Durham, NC

1d•Remote

About The Position

We are currently seeking Experienced Oncology CRAs to lead and support our Full Service Outsourcing team working with various sponsors. 1+ year of independent CRO/sponsor monitoring required. CAR-T desired. Open to major hub locations across the US. 60-70% travel, 8-10 DOS per month.

Requirements

University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g. nursing licensure)
1+ years of Clinical Monitoring experience
Oncology experience is desired
Open to various hub locations
Comfortable working in a fast-paced environment where no deviations from the study protocol are allowed, and not meeting a timeline for even few minutes will create a quality issue.
Comfortable with changing priorities constantly asking you to prioritize and adapt on the spot.
Teamwork and people skills are essential for the study to run smoothly.
Technology based. We collect our data directly into an electronic environment.

Nice To Haves

CAR-T desired

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
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, 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
Perform other duties as assigned by management