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

Role Summary

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

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, 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

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

• Clinical monitoring expertise, regulatory compliance knowledge, data integrity and SAE reporting
• Training and mentoring abilities
• Ability to coordinate multiple clinical projects and act as local client contact as assigned
• Strong communication and teamwork abilities
• Technology-driven with experience in electronic data capture environments

Education

• As listed in Qualifications (degree or certification in a related allied health profession)

Additional Requirements

• Travel: Frequent travel to clients/site locations with occasional travel both domestic and international
• Location: Midwest, Arizona, Texas, New Mexico; open to hub airports with direct flights to Puerto Rico