CRA 1 (Florida, Georgia, Tennessee, Louisiana, Alabama) - Remote

The Clinical Research Associate may be regionally based and 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.

The CRA will 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. 

What you will be doing:Study Planning• Contribute to the identification of new sites for clinical trials; analyse capability and support CRMA and CSM in making recommendation for trial inclusion.• Assume ambassadorial role to facilitate communication between sites and Novartis CPO to increase value proposition to investigators.• Facilitate the preparation and collection of site and country level documents during all phases of the trial. Supports the CSM in the oversight of Country and Site Trial Master Files (TMF). During all phases of the trial ensure archiving per relevant SOP.• Negotiate investigator remuneration; prepare financial contracts between investigational sites and investigators. Ensure adherence to payment schedule.Study Execution• Implement complete site management including monitoring visits, regulatory assessment, drug supply management, etc. to ensure compliance with protocol, GCP, global and local regulations, global and local processes.• Identify problems at sites; resolve issues and escalate as appropriate.• Collaborate with the CSM to ensure recruitment and execute contingency plans, as needed.• Complete preparation and generation of visit monitoring reports as per relevant SOP• Review and manage data at site; resolve technical and content issues on a continuous basis in order to achieve timely database lock targets.• If working with central CRAs (blinded and un-blinded), respond to alerts and follow-up to ensure resolution of issuesStudy Close-out• Implement site close-out activities and generate site close-out report.• Provide feedback on site performance for future trial site feasibility/selectionGeneral• Improve skills by timely completion performance of assigned global and local training.

You are:

• Minimum 1 year prior monitoring experience with global trials.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
• CCRA or SoCRA certified

Why ICON?Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.