Senior Clinical Research Associate - JHB at ICON plc

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