# Study Start Up Clinical Research Associate

**Company**: ICON Strategic Solutions
**Location**: Kenya
**Experience**: senior
**Job type**: full-time
**Category**: Research
**Industry**: Healthcare

**Apply**: https://icon.wd3.myworkdayjobs.com/en-US/broadbean_external/job/Kenya/Study-Start-Up-Clinical-Research-Associate_JR163168?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/job/study-start-up-clinical-research-associate-99c3c172-037/

## Description

As a Study Start-Up Clinical Research Associate at ICON, you will work in a sponsor-dedicated model, supported by ICON's global expertise.

You will be responsible for managing site-level study start-up activities from site selection through to site activation, ensuring clinical trial sites are activated efficiently and in accordance with ICH-GCP, local regulatory requirements, and applicable SOPs.

Key responsibilities include:

- Manage end-to-end study start-up activities for assigned sites, from site selection through to site activation

- Conduct site selection activities and assess site suitability, working directly with Principal Investigators and investigational site teams

- Independently prepare, coordinate, and manage regulatory authority and Ethics Committee/IRB/IEC submissions, including responding to queries and resolving deficiencies

- Coordinate the collection, review, and tracking of essential regulatory documentation, including ICFs, CVs, GCP certificates, financial disclosures, and other site-specific documents

- Maintain study start-up systems, trackers, and country/site TMF documentation, ensuring documentation is complete, accurate, and inspection-ready

- Partner with sites and internal stakeholders to proactively resolve start-up issues, support vendor, contract, and investigator payment activities where required, and minimise activation delays

- Ensure sites are fully prepared for site activation and coordinate a seamless handover to the execution CRA

To succeed in this role, you will bring strong clinical trial study start-up and regulatory experience, with the ability to independently manage site activation activities and regulatory submissions.

Required qualifications and experience:

- Previous experience in clinical trial study start-up, site activation, and regulatory submissions

- Demonstrated experience independently managing end-to-end site start-up activities through site activation

- Proven experience independently preparing and managing regulatory authority and Ethics Committee/IRB/IEC submissions, including responding to regulatory and ethics queries

- Strong knowledge of ICH-GCP, local regulatory requirements, essential regulatory documentation, and TMF requirements

- Strong organisational and stakeholder-management skills, with the ability to manage multiple sites, timelines, and competing priorities independently

- Candidates must be based in either Nairobi or Kisumu, Kenya.

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

- Competitive base salary and performance-related incentives

- Health and wellbeing programmes including medical, dental, and vision coverage where applicable

- Retirement and pension plans

- Life assurance and disability coverage

- Employee assistance programmes and wellbeing resources

- Learning and development opportunities through structured training and career pathways

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## Skills

### Required
- ICH-GCP
- regulatory submissions
- study start-up
- site activation
- GCP certificates
- TMF requirements

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