Phase I Clinical Research Associate II - Remote

Fortrea; United States; Remote; USD 105,000 - 118,000; Full time

Job summary

Fortrea is seeking a Clinical Research Associate with 1+ years of experience to monitor Phase I studies. The role focuses on site monitoring, data integrity, and regulatory compliance, with significant travel to sites.

The candidate should reside in Florida and be comfortable with a fast-paced, team-oriented environment. Responsibilities include site visits, training, SAE reporting, and coordinating project activities as needed.

Qualifications

• 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
• Phase I experience
• 40-50% overnight travel

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, ifapplicable) and may act as a local client contact as assigned
• Perform other duties as assigned by management

Skills

Clinical Monitoring

Phase I

Overnight travel

Education

Bachelor's degree or related allied health

Job description

Fortrea is seeking a Clinical Research Associate with 1+ years of experience to monitor Phase I studies. The role focuses on site monitoring, data integrity, and regulatory compliance, with significant travel to sites.

The candidate should reside in Florida and be comfortable with a fast-paced, team-oriented environment. Responsibilities include site visits, training, SAE reporting, and coordinating project activities as needed.