Key Facts

Remote From:

Full time

English

Hard Skills

Clinical Trials KPI Reporting Regulatory Compliance Reimbursement Regulations Project Management Compliance Management Pre-Clinical Development Clinical Trial Management Systems General Data Protection Regulation (GDPR) Recruitment Software Change Management Strategy Continuous Improvement Process Stakeholder Communications Self-Regulation Issue Management

Other Skills

•
Prioritization
•
Communication
•
Negotiation
•
Timelines
•
Organizational Skills
•
Prioritization
•
Problem Solving

Roles & Responsibilities

Bachelor’s degree in a scientific or health-related field; two years clinical research experience or relevant experience preferred
Understanding of the clinical development paradigm and the importance of efficient site activation; applied knowledge of project management
Effective communication, negotiation, and problem-solving skills; self-management and strong organizational abilities
Experience managing regulatory activation for multiple sites (approximately 25-30 sites per FTE) in a compliance-driven environment

Requirements:

Initiate investigator site activities: collection and submission of regulatory documents, customization and negotiation of informed consent form (ICF) documents, and serve as the point of contact for the site's IRB
Manage site regulatory maintenance and changes: ICF updates from amendments and IB/risk profile changes, and management of site changes (personnel, location); track site training and ensure compliance
Drive start-up and collaboration: communicate directly with sites to enable start-up, maintain active collaboration, identify and resolve issues, and populate internal systems and Trial Master Files with accurate data
Ensure regulatory and data privacy compliance: incorporate country-specific requirements into submissions and systems; leverage prior site/IRB engagements for new work and adapt to changing trial priorities; provide feedback for continuous improvement

ICON plc

Pharmaceuticals

About ICON plc

Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life. We do this by delivering best in class information, solutions and performance, with an unyielding focus on quality at all times. We offer a full range of consulting, development and commercialisation services from a global network of offices in 53 countries. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost, and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas.

Company type: XLarge

Industry: Pharmaceuticals

Founded: 2018

Company size: 10001

Website LinkedIn See all jobs →

Job description

Site Activation and Maintenance Associate I

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

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

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 maximize 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 site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. 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 or submit a request here.

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.

Are you a current ICON Employee? Please click here to apply