Fortrea · 4 days ago
FSP - CRA I - Southeast FL, Oncology, Spanish Speaking Preferred
Florida, United States
Full-time
Onsite
New Grad, Entry Level
$85K/yr - $89K/yr
0+ years expFortrea is seeking a CRA I to join their FSP Team in Miami or Orlando, Florida. The role involves site monitoring and management for clinical studies, ensuring compliance with regulatory guidelines and project plans.
Clinical TrialsHealth Care
Responsibilities
Responsible for all aspects of study site monitoring including routine monitoring and closeout 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 Responsibilities
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 review
Monitor data for missing or implausible data
Ensure the resources of the Sponsor and Fortrea are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Fortrea travel policy
Ensure audit readiness at the site level
Travel, including air travel, may be required and is an essential function of the job
Prepare accurate and timely trip reports
Interact with internal work groups to evaluate needs, resources, and timelines
Act as contact for clinical trial supplies and other suppliers (vendors) as assigned
Responsible for all aspects of registry management as prescribed in the project plans
Undertake feasibility work when requested
Participate in and follow-up on Quality Control Visits (QC) when requested
Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor as assigned 18) Assist Senior CRA with managing investigator site budgets
Track and follow-up on 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, mentoring and development of new employees, e.g., 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
Required
University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure). An equivalent amount of experience can be substituted as appropriate
Fortrea may consider relevant and equivalent experience in lieu of educational requirements
Basic knowledge of Regulatory Guidelines
Basic understanding of the clinical trial process
Fluent in local office language and in English, both written and verbal
Six (6) months onsite monitoring experience
Basic understanding of Regulatory Guidelines
Ability to work within a project team
Good planning, organization, and problem-solving skills
Good computer skills with good working knowledge of a range of computer packages
Works efficiently and effectively in a matrix environment
Valid Driver's License
Preferred
One (1) or more year's additional experience in a related field (i.e., medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing) is preferred
6 months on site monitoring experience
Ability to maintain confidentiality of data and information during interactions with staff at all levels and across studies and sponsors
Demonstrated ability to conduct clinical operations activities most effectively and efficiently
Attention to detail
Methodical approach to work
Understanding of medical and clinical research terminology and clinical research processes
An understanding of the basics of physiology, pharmacology, and medical devices (when applicable)
Understanding of the principles of ICH GCP, ISO 14155 (if applicable) and regulatory requirements
Good computer literacy with working knowledge of PCs, Windows, and Microsoft Office applications
Good oral and written internal and external communication. Strong interpersonal team and organizational skills, personal presentation. The ability to communicate effectively in English
Experience using a clinical trial management system (CTMS)
For medical device positions, experience in providing customer service to device end users
Benefits
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
Fortrea
Fortrea is a provider of comprehensive Phase I through IV clinical trial management, clinical pharmacology, patient access solutions.
10001+ employees
H1B Sponsorship
Fortrea has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (14)
2024 (25)
2023 (6)
Funding
Current Stage
Late StageLeadership Team
Anshul Thakral
Chief Executive Officer
Agnieszka Gallagher
General Counsel, Chief Compliance Officer and Corporate Secretary
Recent News
2026-01-06
Business Wire
2025-12-11
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