Senior Clinical Research Associate

Clinical Research Associate – Johannesburg, South Africa

As a Clinical Research Associate, you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. You will be a part of ICON Strategic Solutions, embedded to a sponsor.

We believe our Clinical Operations team is second to none. You will receive the support you need to develop personally and professionally and work in an environment where you matter. Our team pushes forward together. United in solving problems, developing close site relationships, and reaching the end goal. Operating as a key part of a global study team, the CRA plays a fundamental role in our clients’ drug development processes.

Here at ICON, we want our employees to succeed and ensure that they are set up for this success through constant training, development and support.

The Clinical Research Associate is ultimately responsible for the successful management of investigator sites and monitoring activities for assigned clinical studies throughout the trial lifecycle.

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:

• Prior experience of working in investigator site management, including conducting monitoring visits, from either a pharmaceutical company or a CRO environment.
• A minimum of 3 years of on-site independent monitoring experience is required in medium-sized studies, including study start-up and close-out.
• You will be educated to degree level, within an applicable field.
• 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.
• Ideally having gained expertise in multi-therapeutic areas.
• Must be based in Gauteng, South Africa

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
• 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 assuranceVisit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefitsICON, including subsidiaries, 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, 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 or submit a request here.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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