FSP - Spanish Speaking Sr CRA 2 - Midwest, Arizona, Texas, New Mexico

Role Summary

FSP - Spanish Speaking Sr CRA 2 - Midwest, Arizona, Texas, New Mexico. Experienced Sr. CRAs fluent in Spanish, residing in the Midwest US or open to hub airports with direct flights to Puerto Rico. This FSP aligned role works with IVD clinical trials.

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 monitoring 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 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 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

Qualifications

• University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g. nursing licensure)
• 4+ years of onsite Clinical Monitoring experience
• Various therapeutic experience required
• Open to major hub locations in the Northeast US

Skills

• Strong clinical monitoring and site management abilities
• Regulatory compliance and informed consent proficiency
• Data integrity and CRF review
• Training and mentorship capabilities

Education

• Relevant degree or allied health certification as noted in Qualifications

Additional Requirements

• Travel: Frequent travel to clients/site locations with occasional travel both domestic and international
• Environment: Fast-paced, high adherence to protocol timelines, and teamwork-focused