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.
- Minimum Qualification:Degree
- Experience Level:Entry level
- Experience Length:1 year
Key Areas of Responsibilities:
- Clinical Research Associate is ultimately responsible for the successful management of investigator sites throughout the site lifecycle, whilst working in accordance with ICH-GCP guidelines, the study protocol, applicable local and international regulatory requirements and internal Standard Operating Procedures.
- With full ownership of investigator sites for assigned studies, the Clinical Research Associate’s (CRA) involvement begins at site feasibility stage, with responsibility for the successful management of the site right through to close-out.
- In addition to planning and conducting various site visits (feasibility, site selection, interim and close-out) in accordance with the clinical monitoring plan, the Clinical Research Associate (CRA) fosters effective relationships with investigator site staff to ensure that key clinical metrics are met. This involves establishing innovative ways of increasing site and patient recruitment.
- When issues do occur, the Clinical Research Associate proactively and promptly implements corrective action plans, and, when applicable, escalates issues to more senior members of the study team. The Clinical Research Associate may also design and deliver training to site staff, when appropriate.
- Typical duties for a Clinical Research Associate will likely include preparing for and attending investigator meetings, coordinating the timely shipment and the subsequent proper storage and accountability of clinical supplies and following up of drug safety issues that have occurred at site. The Clinical Research Associate ensures integrity of clinical data through an ability to sufficiently maintain site tracking records and work diligently to relevant guidelines.
- 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. To enable success in this position you will have:
- A minimum of 12 months experience of working in investigator site management, including conducting independent monitoring visits, from either a pharmaceutical company or a CRO environment.
- You will be educated to degree level, have equivalent experience or be a licensed healthcare professional.
- A working knowledge of ICH-GCP guidelines and local/international regulatory requirements.
- Experience in monitoring all trial components
- Strong communication skills
- Fluency in English
- Need to be based in Ghana
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