Study Start Up Associate II (UK or Ireland)
About the role
This vacancy has now expired. Please see similar roles below...
Are you interested in improving your knowledge of Clinical Trials and contributing to our culture of process improvement with a focus on streamlining our processes of adding value to our business and meeting client needs?
Study Start Up Associate role within ICON:
Selected to coordinate clinical trial start-up activities and serve as primary contact for investigators and research coordinators in corporate sponsored human clinical trials.
Prepare, review and submit submissions to ethics and regulatory and other relevant authorities in order to obtain all necessary authorizations/approvals pertaining to the clinical trial conduct.
This includes, but it is not limited to:
Develop and finalize Country Specific SIS/ ICFs.
Prepare and finalize Country Specific xml files (if applicable for region).
Review and translate Drug Labels.
Perform independent quality review of submission packages.
Collect and maintain current Regulatory/Competent Authority (CA) and Ethics Committee (EC) submission information, and similar information for other related organizations, for the assigned countries and update relevant ICON information system.
Responsible for the translation and co-ordination of translations for documents required for submission (if applicable for region).
Perform timely and accurate data entry of regulatory documents, submission status and maintenance of Country/Investigator information in the appropriate clinical trial management system.
Copy and route incoming correspondence, internal documentation, etc., as appropriate.
Assist and provide support to the Study Start Up Lead to maximize submission effectiveness, minimize timelines and ensure sponsor satisfaction.
To succeed you will need:
A high school diploma or local equivalent, Bachelor’s Degree preferably in life sciences will ensure your familiarity with regulatory guidelines and industry knowledge. Minimum of 1 year of experience or understanding of clinical study start up requirements and activities.
What’s Next?
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 is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.
*LI-PW1
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
Italy
Department
Clinical Monitoring
Location
Italy
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
2024-109810
Expiry date
01/01/0001
Author
Mattia CarcangiuAuthor
Mattia CarcangiuSalary
Location
UK, Reading
Department
Full Service - Development & Commercialisation Solutions
Location
Dublin
Reading
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Medical Communications
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
JR117741
Expiry date
01/01/0001
Author
Hannah PetitjeanAuthor
Hannah PetitjeanSalary
Location
India
Department
Biometrics Roles
Location
India
Business Area
ICON Strategic Solutions
Job Categories
Biometrics Portfolio
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
2024-109792
Expiry date
01/01/0001
Author
Abhisikta MishraAuthor
Abhisikta MishraSalary
Location
Poland, Warsaw
Department
Full Service - Development & Commercialisation Solutions
Location
Sofia
Warsaw
Lisbon
Bucharest
Barcelona
Edinburgh
Reading
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Engineering
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
JR117116
Expiry date
01/01/0001
Author
Katty Barreto MaiaAuthor
Katty Barreto MaiaSalary
Location
Israel
Department
Clinical Monitoring
Location
Israel
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 organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotech
Reference
2024-109585
Expiry date
01/01/0001
Author
Salome KankiaAuthor
Salome KankiaSalary
Location
Turkey, Istanbul (PRA)
Department
Clinical Monitoring
Real World Solutions
Location
Istanbul
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Clinical Monitoring
Job Type
Permanent
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 and biot
Reference
JR117999
Expiry date
01/01/0001
Author
Lourdes Roy PratsAuthor
Lourdes Roy Prats