Senior Cra

2 weeks ago

Johannesburg, South Africa Icon plc Full time

**Overview**:
**Senior CRA Oncology/Hematology - Johannesburg (Home based)**

As a Senior CRA you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

**Responsibilities**:
**Responsibilities**
- Full ownership of investigator sites for assigned studies, with responsibility for the successful management of the site right through to close-out, in accordance with the clinical monitoring plan.
- Work collaboratively with investigative sites to develop strong, long-term, working relationships.
- Help identify and qualify potential investigators.
- Perform all type of visits from Pre-Study to Close out.
- Provide initial and ongoing training to site personnel regarding the study protocol, applicable policies/procedures, and GCP.
- Assist with start-up activities, including essential document review and collection as requested.
- Lead and drive regulatory Ethics Committee submission and site start-up activities in partnership with investigator sites including the support of EC follow up queries and responses as required.
- Liaise with sites to support contracts/budget negotiation and support the development and adaptation of country/site specific informed consent forms under the direction of the internal team.

**Qualifications**:
**Requirements**:

- Prior experience of working in investigator site management, including conducting monitoring visits, from either a pharmaceutical company or a CRO environment in South Africa
- A minimum of five years of on-site monitoring experience is required, covering medium-sized studies from start-up through close-out, with specific experience in Oncology and Hematology trials.
- You will be educated to degree level, within an applicable field.
- Excellent written and verbal communication skills.
- Ability to work to tight deadlines.
- Availability to travel least 60% of the time and should possess a valid driving license
- A working knowledge of ICH-GCP guidelines and local and international regulatory requirements is essential.
- Based in Johannesburg and prepared to travel within South Africa

**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 maximise 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

LI-SB1#Home-based

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