Senior CRA

ICON; South Africa; Hybrid; ZAR 600,000 - 850,000; Full time

Job summary

A leading clinical research organization seeks a Senior Clinical Research Associate. You will manage investigator sites, ensuring compliance with protocols and building long-term relationships. The role requires extensive site management experience and offers a competitive salary with comprehensive benefits.

Benefits

Annual leave entitlements

Health insurance offerings

Retirement planning

Global Employee Assistance Programme

Life assurance

Flexible optional benefits

Qualifications

• 4+ years' experience in investigator site management.
• Degree level education in a relevant field.
• Knowledge of ICH-GCP guidelines.

Responsibilities

• Manage investigator sites for assigned studies from start to close-out.
• Develop relationships with investigative sites.
• Provide training and support to site personnel on protocols and procedures.

Skills

Communication

Time Management

Investigator Site Management

Education

Degree in applicable field

Job description

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

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.
• Apply SOPs, Clinical Monitoring Plan (CMP), study manuals and other materials and guidelines as applicable.
• 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.

To enable success in this position you will have:

• Over 4 years’ experience working in investigator site management, including conducting monitoring visits, independently from either a pharmaceutical company or a CRO environment.
• You will be educated to degree level, within an applicable field.
• Cardiovascular and Hematology study experience is crucial.
• Based in Gauteng, South Africa.
• Excellent written and verbal communication.
• 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.

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

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.

https://careers.iconplc.com/reasonable-accommodations

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

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