Study Start Up Associate

ICON Strategic Solutions; South Africa; On-site; ZAR 350,000 - 550,000; Full time

Benefits offered by this job

Annual leave entitlements

Health insurance

Retirement planning

Employee Assistance Programme LifeWor­

Life assurance

Country-specific benefits

Job summary

ICON Strategic Solutions is seeking a Study Start Up Associate to drive site start-up and activation activities across trials, ensuring regulatory compliance and timely study initiation. You will collaborate with cross-functional teams and external stakeholders to deliver high-quality submissions.

You will bring hands-on experience in regulatory submissions (CTF 1-3), site activation, and coordinating with Ethics Committees/IRBs, regulatory authorities, and study teams.

Qualifications

• Bachelor's degree in Life Sciences or related field.
• Experience in Study Start-Up / Site Activation in a clinical research environment.
• Proven track record completing CTF 1, 2 and 3 submissions from start to finish.
• Experience preparing, reviewing, coordinating and submitting all required documentation across the CTF submission stages.
• Strong regulatory and documentation knowledge for trial start-up.
• Experience coordinating with sites, Ethics Committees/IRBs, Regulatory Authorities and internal teams.
• Ability to manage multiple studies/sites and submission timelines in a fast-paced environment.
• Excellent communication and interpersonal skills.

Responsibilities

• Deliver site start-up and activation work to a high standard with the team.
• Prepare and submit regulatory documents such as clinical trial applications and ethics submissions.
• Coordinate with stakeholders to obtain approvals for study initiation.
• Maintain accurate records of regulatory submissions and approvals.
• Support study teams in developing study documents (protocols, informed consent forms, investigator brochures).
• Participate in start-up meetings and provide input on regulatory timelines.

Skills

Study Start-Up / Site Activation

CTF submissions (1-3)

Regulatory documentation coordination

Stakeholder coordination

Multi-study management

Attention to detail

Regulatory knowledge for trials

Communication skills

On-site work flexibility

Education

Bachelor's degree in Life Sciences

Job description

At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise.

As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

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

What You Will Do

Your role will involve delivering site start-up and activation work to a high standard, working closely with your team and stakeholders.

Key Responsibilities Include

• Preparation and submission of regulatory documents, such as clinical trial applications and ethics committee submissions.
• Coordinating with internal and external stakeholders to obtain necessary approvals and authorizations for study initiation.
• Maintaining accurate and up-to-date records of regulatory submissions and approvals.
• Supporting study teams in the development of study documents, including protocols, informed consent forms, and investigator brochures.
• Participating in study start-up meetings and providing input on regulatory requirements and timelines.

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.
• Demonstrated experience within Study Start-Up / Site Activation in a clinical research environment.
• Proven experience independently completing CTF 1, CTF 2 and CTF 3 submissions from start to finish.
• Experience preparing, reviewing, coordinating and submitting all required documentation across the CTF submission stages.
• Strong understanding of regulatory and documentation requirements associated with clinical trial start-up and site activation.
• Experience coordinating with sites, Ethics Committees/IRBs, Regulatory Authorities and internal study teams, as applicable.
• Ability to independently manage multiple studies, sites, submission requirements, timelines and follow-up activities in a fast-paced environment.
• Strong organisational skills and attention to detail.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
• Willingness to work from the office 2–3 days per week.

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.

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.