Clinical Research Associate

5 months ago

Johannesburg, South Africa ICON plc Full time

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.

ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations.

With our patients at the center of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

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.
- Full ownership of investigator sites for assigned oncology 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.
- Prior experience of working in investigator site management, including conducting monitoring visits, from either a pharmaceutical company or a CRO environment.
- A minimum of 18 months of on-site independent monitoring experience is required in oncology 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.
- Must having gained expertise in oncology studies.
- Must be based in Johannesburg, South Africa.

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