Remote Study Start-Up Lead

Placements24; Klerksdorp; Hybrid; ZAR 420,000 - 660,000; Full time

Benefits offered by this job

Health insurance

Retirement planning

Employee Assistance Programme

Life assurance

Job summary

ICON Strategic Solutions is seeking a Study Start-Up Associate to support site start-up and activation in a sponsor-dedicated model. You will coordinate regulatory submissions (CTF 1–3), liaise with Ethics Committees/IRBs and Regulatory Authorities, and prepare study documents including protocols and informed consent forms.

The role requires a Life Sciences degree, strong organizational and communication skills, and willingness to work from the office 2–3 days per week.

Qualifications

• Bachelor's degree in Life Sciences or related field.
• Experience in Study Start-Up / Site Activation in a clinical research environment.
• Proven experience completing CTF 1, 2 and 3 submissions from start to finish.
• Experience coordinating with Ethics Committees/IRBs, Regulatory Authorities and study teams.
• Strong organisational skills and attention to detail.
• Excellent communication and interpersonal skills.
• Willingness to work from the office 2-3 days per week.

Responsibilities

• 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.

Skills

Study Start-Up

Site Activation

CTF Submissions

Regulatory Coordination

Documentation & Compliance

Regulatory Liaison

Communication Skills

Multitasking

Education

Bachelor's degree in Life Sciences

Job description

ICON Strategic Solutions is seeking a Study Start-Up Associate to support site start-up and activation in a sponsor-dedicated model. You will coordinate regulatory submissions (CTF 1–3), liaise with Ethics Committees/IRBs and Regulatory Authorities, and prepare study documents including protocols and informed consent forms.

The role requires a Life Sciences degree, strong organizational and communication skills, and willingness to work from the office 2–3 days per week.