Study Start Up Associate

ICON Clinical Research; South Africa; Remote; ZAR 420,000 - 560,000; Full time

Benefits offered by this job

Annual leave entitlements

Health insurance offerings

Retirement planning

Life assurance

Global EAP program

Job summary

ICON Strategic Solutions is seeking a Study Start Up Associate in South Africa to join our sponsor-dedicated model. You will facilitate initiation of clinical trials, ensuring regulatory compliance and effective site activation.

You will work with cross-functional teams to prepare regulatory documents, coordinate with Ethics Committees/IRBs and regulatory authorities, and manage multiple studies with strong attention to detail. A life sciences degree and hands-on start-up experience are required.

Qualifications

• 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 coordinating documentation across CTF submission stages.
• Strong understanding of regulatory and documentation requirements for start-up and site activation.
• Ability to manage multiple studies, sites, and timelines in a fast-paced environment.

Responsibilities

• Delivery of site start-up and activation work to a high standard with team collaboration.
• Preparation and submission of regulatory documents (CTAs, ethics submissions).
• Coordinate with internal/external stakeholders for approvals and authorizations.
• Maintain accurate records of regulatory submissions and approvals.
• Support study teams in developing study documents (protocols, ICFs, investigator brochures).
• Participate in start-up meetings and provide input on regulatory timelines.

Skills

Study Start-Up / Site Activation

Regulatory submissions

Cross-functional collaboration

Project management

Communication skills

Education

Bachelor's degree in Life Sciences or related field

Job description

Study Start Up Associate

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 (https://careers.iconplc.com/benefits) 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 (https://careers.iconplc.com/reasonable-accommodations)