Hybrid Study Start-Up Associate | Clinical Trials

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

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.