Senior Ophthalmology CRA - Remote + Travel

Fortrea; Baltimore (MD); Remote; USD 130,000 - 142,000; Full time

Job summary

Fortrea seeks a Senior Clinical Research Associate (CRA) with ophthalmology expertise to lead site monitoring, ensure protocol adherence, and maintain study files from initiation to close-out. You will liaise with vendors and support site management across multiple studies.

The role requires 3+ years of clinical monitoring experience, a university or allied health degree, and 30-50% overnight travel. Major hub locations in California, Texas, and the Southeast & Northeast US are considered.

Qualifications

• University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g. nursing licensure)
• 3+ years of Clinical Monitoring experience
• 30-50+% overnight travel
• Ophthalmology experience

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 MonitoringEnsure 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 repos, 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

Skills

3+ years Clinical Monitoring

Ophthalmology experience

30-50% overnight travel

Education

University degree or allied health certification

Job description

Fortrea seeks a Senior Clinical Research Associate (CRA) with ophthalmology expertise to lead site monitoring, ensure protocol adherence, and maintain study files from initiation to close-out. You will liaise with vendors and support site management across multiple studies.

The role requires 3+ years of clinical monitoring experience, a university or allied health degree, and 30-50% overnight travel. Major hub locations in California, Texas, and the Southeast & Northeast US are considered.