CRA I (Baltimore MD or DC) - Remote

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.

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 issues

Study Close-out
• Implement site close-out activities and generate site close-out report.
• Provide feedback on site performance for future trial site feasibility/selection

General
• 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
• Bachelors of Science
• 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

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, 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 through the form below.

https://careers.iconplc.com/reasonable-accommodations

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.