FSP CRA 2 & Sr. CRA - Oncology & Multi Specialty TAs - Remote US

Fortrea•Washington, DC

1d•Remote

About The Position

The FSP team is seeking experienced Clinical Research Associates for Oncology and Multi-Specialty therapeutic areas. The role is remote in the US and open to candidates in major US hub locations. CRAs are expected to complete 8–10 days on site per month, with regionalized travel where possible and no hard monitoring metrics. Oncology monitoring experience is desired. The position involves providing a high standard of care for clinical trial participants and responding to emergency situations according to clinical research standards. It also includes frequent travel to client and site locations, with occasional domestic and international travel.

Requirements

University or college degree, or certification in a related allied health profession from an appropriately accredited institution, such as nursing licensure.
3 or more years of clinical monitoring experience.
Ability to travel overnight 30–50% or more.
Ophthalmology experience.
Comfort working in a fast-paced environment where protocol deviations are not allowed and tight timelines are important.
Ability to adapt to constantly changing priorities.
Teamwork and interpersonal skills.
Comfort working in a technology-based environment where data is collected electronically.

Nice To Haves

Oncology monitoring experience.

Responsibilities

Conduct all aspects of study site monitoring, including routine monitoring, site close-out, maintenance of study files, and pre-study and initiation visits.
Liaise with vendors and perform other assigned duties.
Manage sites according to project plans.
Conduct general on-site monitoring.
Ensure study staff have the materials and instructions needed to safely enroll patients in the study.
Protect study participants by verifying that informed consent procedures and protocol requirements meet applicable regulatory requirements.
Verify the integrity of data submitted on Case Report Forms (CRFs) or other data collection tools through careful source-document review, and monitor for missing or implausible data.
Manage registries according to project plans and undertake feasibility work when requested.
Complete Serious Adverse Event (SAE) reporting, prepare reports and narratives, and follow up on SAEs.
Independently review CRFs and generate and resolve queries according to established data review guidelines on Fortrea or client data management systems, as assigned by management.
Assist with training new employees, including co-monitoring.
Coordinate designated clinical projects as a Local Project Coordinator, with supervision if applicable, and act as a local client contact when assigned.
Perform other duties assigned by management.