Study Start Up Associate I

Study Start Up Associate 1 - South Africa

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

At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.

Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.

That’s our vision. We’re driven by it. And we need talented people who share it.
If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.

The Role:
Benefits of Working in ICON:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent.

The employee is expected to embrace and where possible contribute to our culture of continuous process improvement with a focus on streamlining our processes, adding value to our business and meeting client needs.

Perform timely and accurate task progress communication and data entry of all relevant study start up activities into the appropriate tracking system.

Coordination of all necessary translations required for any start-up documentation.

Attend study team meetings as required.

Responsible, as assigned, for one or more of the following tasks related to each of the key study start-up activities:

- Assists in identifying study sites by performing site feasibility and recruitment tasks
- Sets up and maintains site-related data in applicable clinical systems according to procedures and guidelines.
- Acts as primary site contact/liaison for study and site management issues relevant to study start-up, including addressing questions, inclusive of protocol questions, managing study supplies and accesses to applicable study systems.
- Preparation, submission, review and approval of IP Release Package (IPP)
- Essential document collection and review, ensuring that Sponsor and Investigator obligations are being met and are in compliance with applicable country requirements and ICH/GCP guidelines.
- Ensure accuracy and completeness of Trial Master File (TMF) documents submitted during start-up.
- Support in forecasting site activation timelines and ensure they are reflected accurately in ICON’s systems and are achieved; work with Site Activation Lead to prepare contingency plans to mitigate impact if forecasted timelines are at risk, and escalate issues as soon as identified.
- Support local regulatory team with submission coordination activities, including relevant local document collection. Submission and coordination of any applicable local submissions including LEC submissions.

What You Need:

- English and Afrikaans speaker
- A high school diploma or local equivalent
- Bachelor’s Degree preferably in Life Sciences
- Minimum of 1 years’ experience or understanding of clinical study start up requirements and activities.
- Experience of Clinical Trial operations and meeting regulatory guidelines, including performing LEC submissions.

We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals - both ours and yours.
We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans - and related benefits such as life assurance - so you can save and plan with confidence for the years ahead.
But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.

ICON is an equal opportunity and inclusive employer and 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.

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