Description
As a Sr. CRA you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Responsibilities
Working fully embedded within one of our pharmaceutical clients, with the support of ICON right behind you, you'll be at the heart of our client's innovation. As a Senior Clinical Research Associate, you will be dedicated to one of our global pharmaceutical clients; a fast-growing biotech company with one of the most exciting product pipelines in the industry.
This global client develops breakthrough innovative medicines to improve and extend people's lives with targeted therapies for cancer. Join the fight against cancer at this sponsor who is running more than 60 clinical trials globally in the area of solid tumors and hematologic cancers.
Position Overview
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 close-out, in accordance with the clinical monitoring plan.
- Conducts monitoring (pre-study, initiation, routine monitoring and closeout visit), Quality Oversight Visits and co-monitoring visits if required.
- Conducts co-monitoring visits, if required.
- Ensures that study milestones for sites responsible are met as planned (i.e., study startup, recruitment, database analyses, closeout, etc.).
- Assists with investigator/site identification, Ethics Committee submissions, site contract and budget negotiation.
- Provides protocol and related study training to assigned sites.
- 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 guideline.
Qualifications
An experienced, ambitious self-starter looking for the opportunity to prove yourself in an embedded role at a top three pharmaceutical company.
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:
- Prior experience of working in investigator site management, including conducting monitoring visits, from either a pharmaceutical company or a CRO environment.
- Experience in oncology studies is an absolute requirement.
- A working knowledge of ICH-GCP guidelines and local and international regulatory requirements is essential.
- You will be educated to degree level, have equivalent experience or be a licensed healthcare professional.
- Fluent in English plus local language requirements.
