CRAs & Sr. CRAs - Oncology or CAR T

Fortrea is a clinical research organization providing clinical trial services to sponsors. The company is seeking Clinical Research Associates to monitor oncology or CAR-T studies, manage study sites and registries, ensure participant protection and data integrity, and support clinical project coordination.

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

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 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 repo11s, 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

Preferred

CAR-T desired

Oncology experience is desired

CAR-T

Oncology experience

Benefits

Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including but not limited to:

Medical, Dental, Vision, Life, STD/LTD (multiple insurance carriers)

401(K)

Paid time off (PTO) – Flex Plan

Employee recognition awards

Multiple ERG’s (employee resource groups)

Company

Global clinical research organization providing clinical development solutions

Durham, North Carolina, USA

https://www.fortrea.com/

Founded in 2023

10001+ employees

Qualifications

1+ year of independent CRO/sponsor monitoring required

60-70% travel, 8-10 DOS per month

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

Open to various hub locations

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

Occasional crouching, stooping, with 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 moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs

Regular and consistent attendance

Varied hours may be required

CAR-T desired

Oncology experience is desired

1+ year of independent CRO/sponsor monitoring required.

Required skills

Represents the skills you have, click on the tags, CAR-T, Nursing Licensure

Preferred skills

CAR-T desired, Oncology experience is desired

Experience

1+ years