Study Start Up Associate I
About the role
This vacancy has now expired. Please see similar roles below...
Study start up associates are integral in ensuring that clinical
research sites are prepared and have the necessary tools and approvals needed
to start the trial of investigational, new pharmaceutical and biological
products for clinical trials.
As a Study Start up Associate you
will be responsible for the independent preparation, review and approval of
country-related submission packages in accordance with ICH, GCP and all
applicable regulations, laws and other guidelines. This role is also
responsible for the independent preparation, review and approval of site level
critical documents for investigation drug release in accordance with regulatory
and sponsor requirements. You would also be involved in the site start up
activity for clinical research, investigative sites. You would play an important role in ensuring
clinical sites are ready for the first day that the drug trial begins. You will prepare the regulatory binder, ship
investigational product, ensure that all documentation is ready an available at
the site, and make sure that sites are ready to be activated to enroll their
first study patient.
We are looking for someone who has
experience working in a clinical environment and who is responsible to handle a
variety of tasks in a short time frame.
You should have knowledge of how an investigative study is run as well
as regulatory requirements. We prefer
someone with a bachelor’s degree and a clinical background with strong clinical
site management experience. Study start up experience is a plus. Experience collecting and submitting
regulatory documents and communicating with investigative sites is
preferred.
This
an exciting opportunity to work within a fast paced, busy study start up
clinical group for a leading global provider of outsourced development services
to the pharmaceutical, biotechnology and medical device industries. We are a company of
13,500 employees in forty countries globally. We differentiate ourselves
by developing innovative solutions to bring life-saving drugs to market faster
and in a more cost-effective way to foster better patient outcomes. We are a top five clinical research
organization with solid earnings and growth potential. Our belief in excellence is our core value in
all that we do for our sponsor partners and the patients that we serve.
As a company we strive to exceed our customers’ expectations in drug
development solutions.
Other than
working with a great team of smart and energetic people, we also offer a very
competitive salary and benefits package that includes an excellent retirement
plan, health coverage, paid time off, income protection insurance programs, and
staff recognition schemes. We care about our people, since they are the
key to our success. We provide an open and friendly work environment where we
empower people and provide them with opportunities to develop their long term
career. Caring for patients
while enjoying what we do and delivering great results is something we can
achieve if we know we can count on each other and have a clear vision of where
we want to go.
ICON is
an equal opportunity employer – Minorities/Females/Disabled/Veterans and
committed to providing a workplace free of any discrimination or harassment.
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
Turkey
Department
Clinical Monitoring
Location
Turkey
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
2023-104179
Expiry date
01/01/0001
Salary
Location
Argentina
Department
Clinical Monitoring
Location
Argentina
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Monitoring
Job Type
Permanent
Description
As Clinical Research Associate (CRA), you will be joining the world's largest & most comprehensive clinical research organization, powered by healthcare intelligence. A CRA is a professional who cont
Reference
2023-103904
Expiry date
01/01/0001
Author
Tulio SanquizAuthor
Tulio SanquizSalary
Location
Argentina
Department
Clinical Trial Management
Location
Argentina
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Trial Management
Job Type
Permanent
Description
As a Clinical Trial Manager you will play a key role in improving the lives of patients by accelerating the development of our customers drugs and devices through innovative solutions.
Reference
2023-103323
Expiry date
01/01/0001
Author
Tulio SanquizAuthor
Tulio SanquizSalary
Location
Belgium, United Kingdom, Denmark, France, Spain, Germany, Netherlands, Switzerland
Department
Medical Affiars & Medical Writing Roles
Location
Belgium
Denmark
France
Germany
Netherlands
Spain
Switzerland
UK
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Medical Writing
Job Type
Permanent
Description
As a Principal Medical Writer you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. As principal medical writer, you will be
Reference
2023-103952
Expiry date
01/01/0001
Author
Natalia RothAuthor
Natalia RothSalary
Location
Ireland, Europe, United Kingdom, South Africa, Poland, Bulgaria, Spain, Germany, Netherlands, Romania, Czech Republic, Slovakia
Department
Biometrics Roles
Location
Any EMEA Location
Bulgaria
Czech Republic
Germany
Ireland
Netherlands
Poland
Romania
South Africa
Spain
UK
Slovakia
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Statistics
Job Type
Permanent
Description
As a Principal Biostatistician you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Reference
2023-104906
Expiry date
01/01/0001
Salary
Location
Mexico, Mexico City
Location
Mexico City
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Early Phase Services
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
JR118557
Expiry date
01/01/0001
Author
Elizabeth DaviesAuthor
Elizabeth Davies