CRA II/Senior CRA
at Icon plc
København, Region Hovedstaden, Denmark -
Start Date | Expiry Date | Salary | Posted On | Experience | Skills | Telecommute | Sponsor Visa |
---|---|---|---|---|---|---|---|
Immediate | 25 May, 2024 | Not Specified | 01 Mar, 2024 | N/A | Good communication skills | No | No |
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Description:
ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre 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.
As a CRA II or Senior Clinical Research Associate at ICON, you’ll work within a large-scale, fast-paced environment alongside a close-knit team of highly qualified CRAs to identify, select, initiate and close-out investigational sites for clinical studies in phases II – IV, ensuring adherence to applicable regulations and principles of ICH-GCP.
Key responsibilities include:
- 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.
- Developing effective relationships with investigator site staff to ensure that key clinical metrics are met.
- Ensuring integrity of clinical data through an ability to sufficiently maintain site tracking records and working diligently to relevant guidelines
- Coaching / Mentoring of fellow CRAs
To enable success in this position you will have:
- At least 2 years as an independent CRA, including conducting monitoring visits for clinical trials, from either a pharmaceutical company or a CRO environment.
- Excellent working knowledge of ICH-GCP guidelines and local and international regulatory requirements is essential.
- You will be educated to degree level in a life science discipline or be a licensed healthcare professional.
- Fluency in Danish and English is essential
- Scientific degree (BSc, MSc or PhD), have equivalent experience or be a licensed healthcare professional.
- Ability to travel across Denmark as required (approx 4-6 times a month)
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.
- Developing effective relationships with investigator site staff to ensure that key clinical metrics are met.
- Ensuring integrity of clinical data through an ability to sufficiently maintain site tracking records and working diligently to relevant guidelines
- Coaching / Mentoring of fellow CRA
REQUIREMENT SUMMARY
Min:N/AMax:5.0 year(s)
Pharmaceuticals
Pharma / Biotech / Healthcare / Medical / R&D
Clinical Pharmacy
Graduate
Proficient
1
København, Denmark