Start-up Senior Cra

3 weeks ago

Johannesburg, South Africa ICON Plc Full time

SSU Senior CRA - Sponsor-Dedicated - South Africa, Johannesburg - Home-Based

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development

We are currently seeking a Study Start-Up CRA to join our diverse and dynamic team.

This role focuses primarily on site start up activities until activation of clinical trials. As an SSU CRA, you will collaborate with cross-functional teams, facilitate the seamless launch of clinical trial sites, and ensure compliance with regulatory and ethical standards. This role is ideal for professionals passionate about advancing clinical research while fostering partnerships with investigators and research sites.

**What You Will Be Doing**:

- Collaborate with internal teams to activate clinical trial sites aligned with project timelines and requirements.
- Develop strong relationships with site personnel to ensure smooth site onboarding and activation.
- Manage start-up documentation and ensure filling
- Ensure that all activities comply with ICH-GCP guidelines, local regulatory frameworks, and internal Standard Operating Procedures (SOPs).
- Track and manage essential documents (e.g., regulatory approvals, contracts) to ensure timely site activation.
- Serve as the primary point of contact between sites, study teams, and external stakeholders throughout the start-up process.
- Collaborate closely with the Regulatory specialist and Local study manager to manage investigator contracts, payments, and site-specific start-up tasks.
- Provide regular status updates to internal and external stakeholders, ensuring alignment with key project milestones.
- Track, report, and analyze key performance indicators (KPIs) related to start-up timelines.
- Proactively identify and resolve issues that could delay study start-up or impact trial deliverables.
- Maintain accurate documentation to facilitate audits and regulatory inspections.
- Support sites through the activation phase until they achieve “Green Light” status for study initiation.
- Coordinate with site staff to ensure all pre-study requirements are met, including contracts, budgets, and essential documentation.
- Assist in audit preparations to ensure compliance with regulatory and ethical standards.

**Your Profile**:

- Bachelor’s degree in life sciences, nursing, or a related field
- Proficiency in English and the local language(s) of assigned sites
- At least 2 years of experience with Study Start Up activities in clinical research, clinical operations, or site management at a CRO or Pharmaceutical company is preferred.
- Strong organizational skills with a focus on timelines and deliverables is required.
- Ability to communicate effectively with cross-functional teams, investigators, and external stakeholders.
- Central or in-house monitoring or field monitoring experience is an added advantage. Strong site management capabilities with demonstrated negotiating and problem-solving skills.
- Knowledge of ICH-GCP guidelines and local regulatory requirements is highly desirable.
- Responsible for meeting start-up timelines and achieving patient enrollment goals.
- Site monitoring will be an added advantage

LI-DK2

LI-Remote

**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, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

Are you a current ICON Employee? Please click here to apply

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