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Fortrea · 1 day ago

Clinical Research Associate II - Dallas, Texas - Phase I

Dallas, TX

Full-time

Onsite

Entry, Mid Level

$100K/yr - $113K/yr

2+ years exp

Fortrea's Clinical Pharmacology Team is hiring a CRA 2 with Phase I experience. The role involves providing high standards of care for participants in clinical trials, managing study sites, and ensuring compliance with clinical research standards.

Clinical TrialsHealth Care

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

Qualification

Clinical MonitoringPhase I experienceNursing licensureTeamworkAdaptability

Required

University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g. nursing licensure)

2+ years of Clinical Monitoring experience

Must reside in Dallas Texas area