Sr CRA 2 - FSP - Chicago & Central US

Role Summary

Sr CRA 2 - FSP - Chicago & Central US. Experienced Sr. CRAs residing in Chicago and the Central region of the US to join our FSP team.

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

Requirements

• 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

• Ability to work in a fast-paced environment with strict adherence to study protocol and timelines
• Strong prioritization and adaptability skills
• Teamwork and people skills
• Technology-based environment with data collected electronically

Education

• Relevant degree or certification as noted in Requirements

Additional Requirements

• Travel expectations include frequent travel to client sites with occasional domestic and international travel
• Physical requirements include ability to sit for extended periods, incidental lifting, and ability to operate a vehicle safely