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. Clinical Research Associate
If you are seeking a career where you can truly make a difference in the lives of others, working closely together with the top minds in the pharmaceutical Industry, then here is your chance. ICON plc is hiring CRA’s jr/md/sr
fully outsourced to Novo Nordisk Nederland.
As a CRA you will coordinate all aspects of the clinical monitoring and site management process in accordance with regulatory guidelines, local regulations and standard operating procedures. In this role you will be a decision maker, solving problems independently but always as part of the client and ICON plc team.
Since ICON plc is a world-leading healthcare intelligence and Clinical Research Organisation, our clients expect us to be an added value to their teams. Therefore, as a CRA I, II, III
at ICON plc we expect you to have:
What will be your responsibilities?
- about 1 to 5 years, (depending on your level) of experience in clinical trial monitoring or similar experience in the industry
- a very good professional knowledge of Dutch and English
- Drivers license
What’s in it for you?
- Performing monitoring visits according to plan, document actions and follow up on action plansSite feasibility visits incl. analysis of site logistics, site personnel performance/quality indicators and accountability for
- patient recruitment strategies
Train and guide site staff in the protocol and trial procedures to minimize protocol deviations (PDs)
- Train site staff in safety information handling and systems
- Know and meet all local and company requirements with respect to safety reporting
- Proactive use of EDC and other data source systems for preparation and conduct of site visits as well as source data verification in collaboration with data management/logistics team
- Identify potential risks and proactively take action to prevent or mitigate
- Collaborate with Data Management/logistics in resolving queries
- Ensure data cleaning cycle timelines are met in accordance with the Data Flow Plan
- Manage trial product requirements, incl. temperature deviations and training of site staff
- Motivate and build strong relations with site personnel to ensure NN is their preferred clinical research partner
- Ensure collaboration with and deliverables from vendors locally, if applicable
- Collection and management of essential documents
- Support the site in filing and archiving trial documentation in the Investigator Trial Master File (ITMF)
- Participation in Investigators Meetings to ensure relations with sites as well as active presentation as applicable
- Knowledge of filing and archiving trial documentation in the Sponsor Trial Master File (STMF)
- Timeliness in deliverables through process planning and goal setting
- Knowledge of IW/VRS functions, incl. training of site staff
- Therapeutic knowledge as applicable demonstrated understanding of diseases and treatments
- Monitor and communicate internally any site observations critical to business results
- Maintain knowledge of and act in compliance with global and local SOPs, GCP and other regulatory requirements
- Support audits and inspections at sites and affiliate, as applicable
- Proficient use of Novo Nordisk systems (e.g. IMPACT, CATS, Investigator Portals)
- Ensure to list compliance/quality related tasks/responsibilities and specific, assigned acts of authority (QMS requirements) - also include information on independence and decision-making authority
You will be part of an organization that has been recognized as one of the world’s leading Contract Research Organizations through a number of high-profile industry awards .
You will work in highly committed and professional teams at Novo Nordisk but also within ICON plc. Since you can work for one single sponsor you will have the opportunity to gain in depth experience and will be fully adapted by Novo Nordisk. We take into account your background and personal interests and see in which team you will fit best. You will be supported by our ICON plc Operations Managers who will make sure that during your career at ICON plc you can develop in the best way.
Because of meeting your colleagues, you are expected once or twice a week at the office at Alphen aan den Rijn.
Work/Life balance we find very important.
Expected visits are 2/4 per month.
We offer you a fixed contract, to be extended into a permanent contract after one year, with an extensive package of benefits like a company car/ car allowance and pension. Benefits of Working in ICON:
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, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.