CRA II - Nationwide

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development as a CRA II. 

What you will be doing:

CRA II  is responsible for the monitoring of clinical trial activities in compliance with FDA regulations, ICH/GCP guidelines and company SOPs, to support New Drug Applications.

• Support project teams in the placement, implementation, communication, site management, recruitment and retention (R&R) issue identification and resolution, and activities required at the conclusion of clinical studies, as stipulated in the monitoring plans for assigned projects.
• Track subject enrollment and identify R&R issues, maintain regular communication w/site staff. Document and communicate study site progress and issues/concerns to the project team.
• Assist other CRAs with study site issues/concerns/audits with the investigator and independently offer resolution strategies, documenting follow-up activities/outcomes.
• Lead or facilitate collaborative CRA efforts to meet company objectives by organizing/managing special data collection efforts, present or set up task force, as directed by CRM/CPL.
• Follow the Site Management / Ownership / Partnership model to monitor multiple Phase II, III & IV clinical trial sites, across therapeutic areas. Independently schedule and prioritize workload to meet projected deadlines.
• Provide adequate reporting and tracking of AEs, protocol deviations and subject status..
• Build regional territory by identifying and maintaining contact with potential (near or long term) research investigators.
• Expand understanding of regulations governing clinical research, beyond FDA regulations and ICH/GCP guidelines, (e.g. international regulatory procedures or high level of proficiency in a specific area, e.g. AE reporting) so as to be a resource for the CRA team.

 You Are:

• Minimum 2 years industry experience as a CRA, or equivalent; experience in clinical medicine (e.g. nursing, laboratory, radiology, pharmacy) or pre-clinical area (e.g. pharmacology, toxicology) desired.
• Medical Device experience preferred 
• Health related background and BS Degree required.
• In-depth knowledge of FDA regulations and ICH/GCP guidelines
• Excellent interpersonal and communication skills (verbal & written), including proficiency in medical terminology and computer systems
• Ability to work effectively with investigators and other research personnel, maintaining a professional demeanor
• Ability to independently resolve site or study related issues Self motivated; detail oriented; team player; flexible
• Ability to prioritize workload to meet project timelines, while managing multiple protocols across therapeutic areas
• Excellent organizational and time management skills
• Function effectively with high degree of personal accountability
• ACRP CCRA or SoCRA certified preferred