Site Activation and Maintenance Associate I

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

Responsibilities

• Initiate investigator site activities, including:
• collection and submission of regulatory documents
• customization and negotiation of informed consent form (ICF) documents
• serve as the point of contact for a site’s institutional review board (IRB)
• track and ensure site compliance to required training
• Study regulatory maintenance activities including, but not limited to:
• Informed Consent Form (ICF) updates resulting from amendments and addenda, IB/Risk profile changes, etc.
• Management of site changes:
• Personnel (PI, Sub-I, Study Coordinators, etc.)
• Location
• Site-specific recruitment, patient facing material, and patient reimbursement
• Effectively drive timelines aligned with company priorities. Communicate directly with sites to enable start-up and maintain an active collaboration with sites
• Identify, communicate, and resolve issues
• Ensure country specific regulatory and data privacy requirements are incorporated into submission documents and any other documents/systems
• Leverage previous site / review board engagements to efficiently drive new work
• Populate internal systems to ensure accuracy of trial / site performance
• Populate Trial Master Files and libraries for future reference
• Provide feedback and shared learning for continuous improvement
• Leverage trial prioritization
• Anticipate and monitor dynamically changing priorities

Qualifications

• Bachelor’s degree preferably in a scientific or health related field, two years clinical research experience or relevant experience preferred
• Understanding of the overall clinical development paradigm and the importance of efficient site activation
• Applied knowledge of project management processes and skills
• Appreciation of / experience in compliance-driven environment
• Effective communication, negotiation, and problem-solving skills
• Self-management and organizational skills
• Management of roughly 25-30 sites in regulatory activation per FTE

Benefits of Working in ICON:

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.

At 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.

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, 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.