CRA II
- Amsterdam
- Clinical Monitoring
- ICON Strategic Solutions
- Remote
About the role
This vacancy has now expired. Please see similar roles below...
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
ICON Strategic Solutions Alphen aan Den Rijn, South Holland, Netherlands (Hybrid)
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 a CRA fully outsourced to our sponsor.
What will be your responsibilities?
- Performing monitoring visits according to plan, document actions and follow up on action plans Site 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
Qualifications:
BSc. or other degree in Life Sciences or equivalent eg. Nursing, medical or as identified in the respective region.
- Ideally experience from a similar position in the pharmaceutical industry or Clinical Research Organization (CRO).
- Other experience may also be relevant, e.g. as study staff at a clinical research site.
- Ability to build and maintain relationships with sites.
- Responsible and accountable.
- Excellent communication and negotiation skills.
- High focus on delivery and quality.
- Adequate Dutch and English verbal and writing skills, e.g. enabling understanding of the protocol and study documents as well as writing monitoring reports.
- IT proficiency.
- Proven decision making and problem-solving capabilities.
- Ability to manage multiple priorities.
- Team oriented personality with high degree of flexibility.
- Ability and willingness to adjust quickly to new situations in a continuously developing environment.
- High degree of trustworthiness.
- Act as an ambassador.
- Flexibility
- Fluently Dutch and English
- What’s in it for you?
- As a CRA, you have the opportunity to grow and to learn.
- It is a Hybrid based position (Alphen ad Rijn) with the flexibility to work from home
- A very good work/life balance
- Limited visits 4/5 per month.
- We offer you a fixed contract of one year, meaning to make it a permanent contract at ICON with an extensive package of extra-legal benefits.
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.
At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
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.
A better career. A better world. A better you.
Our people are our greatest strength, are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers, deliver results to help bring life-changing medicine and devices to market and maintain ICON’s success as an industry leader. See all locations Read more
Day in the life
Teaser label
Our PeopleContent type
BlogsPublish date
08/29/2023
Summary
To excel as a Clinical Research Associate (CRA) in a Clinical Research Organization (CRO), you need a combination of education, skills, and the right mindset. Brazil-based CRA II Debora shares her
Teaser label
Our PeopleContent type
BlogsPublish date
05/23/2023
Summary
How to progress as a Clinical Research AssociateTo thrive as a Clinical Research Associate (CRA), it is imperative to cultivate a multifaceted skill set and demonstrate unwavering commitment to exce
Teaser label
A Day In The LifeContent type
BlogsPublish date
04/05/2023
Summary
Senior Clinical Research Associate Suzaita Hipolito talks about the satisfaction gained from working in Clinical Research. “What would it look like to wake up every day feeling happy and fulfilled?
by
Suzaita Hipolito
Who we are
Similar jobs at ICON
Salary
Location
India, Bangalore
Department
Clinical Monitoring
Location
Bangalore
Chennai
Bengaluru
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Clinical Monitoring
Job Type
Permanent
Description
At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own
Reference
JR118940
Expiry date
01/01/0001
Author
Ekta Chandra SrivastavaAuthor
Ekta Chandra SrivastavaSalary
Location
Malaysia, Kuala Lumpur
Department
Clinical Monitoring
Location
Kuala Lumpur
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Clinical Monitoring
Job Type
Permanent
Description
At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own I
Reference
JR113645
Expiry date
01/01/0001
Author
Alvin ParkAuthor
Alvin ParkSalary
Location
Korea, Seoul
Department
Clinical Monitoring
Real World Solutions
Location
Seoul
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Clinical Monitoring
Job Type
Permanent
Description
At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own I
Reference
JR118943
Expiry date
01/01/0001
Author
Daisy ParkAuthor
Daisy ParkSalary
Location
Chile
Department
Clinical Monitoring
Location
Chile
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Monitoring
Job Type
Permanent
Description
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us
Reference
2024-107984
Expiry date
01/01/0001
Author
Magda ObregonAuthor
Magda ObregonSalary
Location
Netherlands, Utrecht (PRA)
Location
Utrecht
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Clinical Monitoring
Job Type
Permanent
Description
At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own I
Reference
JR119354
Expiry date
01/01/0001
Author
Jakob SchonbergerAuthor
Jakob SchonbergerSalary
Location
Turkey
Department
Clinical Monitoring
Location
Turkey
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Monitoring
Job Type
Permanent
Description
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us
Reference
2024-109830
Expiry date
01/01/0001