Clinical Operations Specialist

ICON; Raleigh (NC); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Annual leave

Health insurance

Retirement planning

Global Employee Assistance Programme

Life assurance

Flexible benefits

Job summary

ICON plc in Raleigh, NC is seeking a Clinical Operations Specialist to lead study start-up activities, ensure regulatory compliance, and collaborate with cross-functional teams to advance clinical development. You will manage regulatory documents, coordinate with stakeholders, and support process improvements while traveling up to 5% as required.

This role requires a life sciences degree and 2+ years in clinical research or regulatory affairs, with strong ICH-GCP knowledge and excellent

Qualifications

• Bachelor's degree in life sciences or related field.
• Minimum of 2 years of experience in clinical research or regulatory affairs, with study start-up experience.
• Strong understanding of regulatory requirements and guidelines for clinical trials, including ICH-GCP and local regulations.
• Excellent organizational and project management skills with ability to prioritize multiple tasks.
• Strong communication and interpersonal skills for cross-functional collaboration.
• Willingness to travel up to 5%.

Responsibilities

• Lead preparation and submission of regulatory documents (CTAs, ethics submissions, regulatory agency communications).
• Coordinate with internal and external stakeholders to obtain approvals for study initiation.
• Maintain comprehensive records of regulatory submissions, approvals, and correspondence.
• Provide guidance on regulatory requirements and best practices for study start-up activities.
• Participate in process improvement initiatives to streamline start-up processes.

Skills

Regulatory knowledge

Study start-up experience

Project management

Communication skills

Travel readiness

Education

Bachelor's degree in life sciences

Job description

Clinical Operations Specialist

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 Study Start Up Associate II at ICON, you will lead the initiation of clinical trials, ensuring compliance with regulatory requirements, and contribute to the advancement of innovative treatments and therapies.

What You Will Do:

You will contribute to site start-up and activation activities, taking responsibility for your deliverables and working collaboratively.

Key responsibilities include:

• Leading the preparation and submission of regulatory documents, including clinical trial applications, ethics committee submissions, and regulatory agency communications.


• Coordinating and liaising with internal and external stakeholders to obtain necessary approvals and authorizations for study initiation.


• Managing and maintaining comprehensive and accurate records of regulatory submissions, approvals, and correspondence


• Providing guidance and support to study teams on regulatory requirements and best practices for study start-up activities.


• Participating in process improvement initiatives to streamline study start-up processes and enhance efficiency.

Your Profile:

You will bring relevant site start-up and activation experience, along with the following qualifications and skills.

Required qualifications and experience:

• Bachelor's degree in life sciences or a related field.


• Minimum of 2 years of experience in clinical research or regulatory affairs, with specific experience in study start-up activities.


• Strong understanding of regulatory requirements and guidelines for clinical trials, including ICH-GCP and local regulatory requirements.


• Excellent organizational and project management skills, with the ability to prioritize and manage multiple tasks simultaneously.


• Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.


• Willingness to travel as required (approximately 5%)

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, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others.

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.