Clinical Research Associate - Johannesburg, South Africa - ICON plc

ICON plc

Verified Company

Johannesburg, South Africa

1 week ago

Posted by:

Thabo Mthembu

beBee Recruiter

Description

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 studies, with responsibility for the successful management of the site right through to closeout, in accordance with the clinical monitoring plan.
Work collaboratively with investigative sites to develop strong, longterm, 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 startup activities, including essential document review and collection as requested.
Lead and drive regulatory Ethics Committee submission and site startup 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 18 months of onsite independent monitoring experience is required in mediumsized studies, including study startup and closeout.
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 multitherapeutic areas.(CV and Respiratory)
Must be based in Johannesburg, South Africa.

Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs.

In addition, our best-in-class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

Our success depends on the knowledge, capabilities and quality of our people.

That's why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.

ICON, 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.