CRA II
About the role
This vacancy has now expired. Please see similar roles below...
Late Phase Clinical Research Associate II and Senior Clinical Research Associate
Location: White City, London, or Marlow, or homebased for a senior candidate.
Combining the industry’s oldest and most experienced Clinical Outcome Assessments (COA) consultancies (Mapi & Oxford Outcomes), within ICON Commercialisation and Outcomes, and with access to more combined COA experience than all other CROs and consultancies, ICON can offer fantastic career opportunities. We provide a dynamic, stimulating and rewarding working environment for ambitious and passionate individuals looking to join a global, world-class consultancy business.
ICON together with Mapi is the leading patient-centered research company serving academia, life science researchers, and the pharmaceutical industry. Our commitment to patients is reflected through our wide range of services, including Real World Evidence, HEOR, Linguistic Validation, Global Market Access, and our Mapi Research Trust. Working within our Real World Evidence team, you will work with a team of professionals who provide strategic and operational expertise in the design and conduct of Post-Approval and commercialization programs for Pharmaceuticals, Biologics and Medical Devices.
Your Responsibilities and Accountabilities:
As a Late Phase Clinical Research Associate, you will be responsible for performing all monitoring and site management activities for observational studies within the Monitoring and Site Management (MSM) team. You will perform routine site visits to ensure that the rights and well-being of human subjects are protected; the trial data is accurate, complete, and verifiable from source documents. You will ensure that all activity is delivered in accordance with the study protocol, GCP/ICH/GEP guidelines and applicable regulatory requirements.
Whilst some travel required dependent upon your study, most of your work will be done on a
remote basis with the primary focus being on the quality of data collected. On average you can expect to do one to two visits per month at a location in the United Kingdom.
Responsibilities:
- Perform site feasibility and site selection in conjunction with the Study team, or independently
- Work closely with relevant departments to perform Regulatory and IEC/IRB submissions and contract negotiations
- Perform onsite and remote visits including pre-study, site initiation, interim and close out to monitor informed consent procedures, compliance protocol, GCP/ICH guidelines and other applicable regulatory requirements and assure appropriate site performance
- Provide timely and accurate visit reports as specified by project specific timelines.
- Contribute to sponsor or regulatory site audits/inspections including preparation, attendance and follow-up of audit findings
- Maintain regular site contacts to ensure site compliance, enrolment and understanding of study requirements
- Maintain the Project Tracking System recording site visit dates, site contact notes, subject and site information
- Maintaining high quality standards, including identifying areas for improvement where applicable
- Assist with the development of departmental and project specific processes and procedures.
You will have:
- A background as a CRA, ideally within late phase studies but not essential
- Strong knowledge of ICH/GCP guidelines and/or other relevant guidelines (GEP, GPP) and local requirements (including regulatory)
- Proficiency with computer/software systems
- Proven ability to manage multiple simultaneous tasks
- Fluency in written and spoken English
.
Education Requirements:
- Bachelor degree or higher preferably in a scientific, medical or life sciences discipline
Next Steps:
Following your application you will be contacted by one of our dedicated recruiters and if successful we will be able to provide you with more details about this opportunity.
ICON Plc is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.
#LI-SG2
Application process
Once you find a job opening that fits your skills and interests, you can create an account, apply and check back on the progress of your application or apply for other roles. Once your application has been received, a confirmation email will be sent to your email.
Remember: this is our first time meeting you. Read the job description and highlight on your CV those experiences that we should learn about.
One of our experienced recruiters will read your profile and determine if you're fit for the role and the company. We are aware of instances where fake recruitment text messages and emails that can appear to come from ICON have been received by individuals. Always delete suspicious text messages or emails. Never give out personal financial information.
Reasonable AccomodationsDay in the life
Teaser label
Inside ICONContent type
BlogsPublish date
04/18/2024
Summary
Endometriosis Awareness: A Vital Cause In March, ICON, through its Networking Organization for Women (NOW) employee resource group, joined the global effort to raise awareness about endometriosis
Teaser label
IndustryContent type
BlogsPublish date
04/18/2024
Summary
Introduction to Data Management in Clinical Trials In the field of clinical research, data management plays a crucial role in ensuring the success and accuracy of clinical trials. Clinical trials
Teaser label
IndustryContent type
BlogsPublish date
04/12/2024
Summary
Introduction to the Clinical Research Supply Chain The clinical research supply chain plays a crucial role in the successful execution of clinical trials. It encompasses a complex network of activ
Who we are
Similar jobs at ICON
Salary
Location
Netherlands, Amsterdam, Schiphol
Location
Amsterdam
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Clinical Trial Support
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
JR119275
Expiry date
01/01/0001
Author
Rajkapoor KamaludeenAuthor
Rajkapoor KamaludeenSalary
Location
Regional Greece (PRA)
Location
Greece
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Study Start Up
Job Type
Permanent
Description
Study Start Up Associate IIAt 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
Reference
JR119024
Expiry date
01/01/0001
Author
Andreia SilvaAuthor
Andreia SilvaSalary
Location
Netherlands, Assen (PRA)
Department
Full Service - Early Clinical and Bioanalytical Solutions
Location
Assen
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Intern
Job Type
Intern
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
JR117103
Expiry date
01/01/0001
Author
Stephanie Broize-ArrieuAuthor
Stephanie Broize-ArrieuSalary
Location
Netherlands, Assen (PRA)
Department
Full Service - Early Clinical and Bioanalytical Solutions
Location
Assen
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Intern
Job Type
Intern
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
JR117101
Expiry date
01/01/0001
Author
Stephanie Broize-ArrieuAuthor
Stephanie Broize-ArrieuSalary
Location
Netherlands, Assen (PRA)
Department
Full Service - Early Clinical and Bioanalytical Solutions
Location
Assen
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Intern
Job Type
Intern
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
JR118435
Expiry date
01/01/0001
Author
Stephanie Broize-ArrieuAuthor
Stephanie Broize-ArrieuSalary
Location
Poland, Warsaw
Location
Warsaw
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Study Start Up
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 fulfill our mission to advance and improve patients' lives.ICON plc i
Reference
JR117566
Expiry date
01/01/0001
Author
Magda KozuszekAuthor
Magda Kozuszek