Study Start Up Associate I
TA Business Partner
About the role
This vacancy has now expired. Please see similar roles below...
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 It' culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.
That's our vision. We're driven by it. And we need talented people who share it.
If you're as driven as we are, join us. You'll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you'll be helping shape an industry.
Study Start Up Associate I
As a member of the Study Start Up Team, you will play an integral role in making sure that physicians at our research sites are prepared to start the trial of investigational, new pharmaceutical and biological products for clinical trials at their local practices.
The Role
* Collect, prepare, review, approve, process and track regulatory and site level critical documents required for study site activation in accordance with ICON SOPs/WPs, Sponsor SOPs, applicable country regulations/guidelines and the principles of ICH/GCP. This may include:
- Prepare, review and approve Subject Information Sheets (SIS) and Informed Consent Forms (ICF)
- Prepare, review and negotiate Clinical Trial Agreements, budgets and any required ancillary agreements with assigned Study Sites, including the facilitation of the indemnification process, between Sponsor and Study Site.
- Collect, review, organize and assemble regulatory initial start-up and maintenance submission packages to Central EC/IRB, Local EC/IRB, Competent Authorities, any other local regulatory authorities as required by countries.
- Essential Country and Site document collection and review, ensuring that Sponsor and Investigator obligations are being met and are in compliance with applicable country requirements.
* To review and negotiate clinical site investigator contracts and budgets.
* Stay connected with Investigative sites, sponsors and internal personnel regarding the status of contracts and contract-related documents
* Prepare and coordinate preparation of contractual documents and correspondence
* Facilitate the indemnification process between the study sponsor and the site.
* Function as the internal consultant on study budgets (investigator payments, develop and update training documentation and conduct group training as necessary, mentor and train new and junior personnel in the SSU department, and act as consultant on the Investigator Contract and Budget development process from origination through execution).
What you need ;
* A bachelor's degree in Life Sciences or related experience is preferred
* Minimum 1 year of study start up experience is required.
* Experience in a clinical research environment with specific experience in study contracts review and budget negotiation or in related field such as where contract or legal document review is a primary part of you role.
* CRA experience can be a plus.
* Fluent in English writing and speaking
* Proficient in MS Office
Benefits of Working in ICON :
Other than working with a great team of smart and energetic people, we also offer a very competitive benefits package. This varies from country to country so a dedicated recruiter will discuss this with you at interview stage.
We care about our people as 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.
ICON is an equal opportunity employer, including disability/veteran, and committed to providing a workplace free of discrimination and harassment.
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
Inclusion & BelongingContent type
BlogsPublish date
04/29/2024
Summary
Cultural Fit in the Workplace Finding the perfect cultural fit is crucial when searching for a new employer. It goes beyond just the job description and salary package. Cultural fit refers to how
Teaser label
IndustryContent type
BlogsPublish date
04/29/2024
Summary
Precision medicine is a groundbreaking approach that aims to revolutionise healthcare by tailoring medical treatments to individual patients. Unlike traditional medicine, which adopts a one-size-fi
Teaser label
Our PeopleContent type
BlogsPublish date
04/29/2024
Summary
Deepak is a Clinical Data Management Project Manager at ICON Strategic Solutions, the largest global provider of Functional Service Provision (FSP). He works as a dedicated resource within one of o
Who we are
Similar jobs at ICON
Salary
Location
United States
Department
Biometrics Roles
Location
United States
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Data Management
Clinical Data Scientist Lead
Clinical Systems
Data Standards Consultant
Job Type
Permanent
Description
As a CDC II you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Reference
2024-110168
Expiry date
01/01/0001
Author
Melissa BennerAuthor
Melissa BennerSalary
Location
US, Raleigh, NC
Department
Full Service - Corporate Support
Location
Raleigh
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 I
Reference
JR118340
Expiry date
01/01/0001
Author
Mitzi OvertonAuthor
Mitzi OvertonSalary
Location
Argentina, Buenos Aires
Location
Buenos Aires
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Clinical Operations Management
Job Type
Permanent
Description
Requirements:Located in ArgentinaBachelor’s degreeAdvanced English LevelMinimum 6 years Clinical Research experience that includes a minimum 4 years relevant experience as a Senior CRA or Principal CR
Reference
JR117295
Expiry date
01/01/0001
Author
Sarah WoodAuthor
Sarah WoodSalary
Location
Turkey
Department
Clinical Operations Roles
Location
Turkey
Business Area
ICON Strategic Solutions
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
2024-110217
Expiry date
01/01/0001
Salary
Location
Denmark
Department
Study Start Up
Location
Denmark
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Study Start Up
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
2024-109975
Expiry date
01/01/0001
Salary
Location
Spain
Department
Clinical Trial Management
Location
Spain
Business Area
ICON Strategic Solutions
Job Categories
Clinical Trial Management
Job Type
Permanent
Description
As a Senior 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. You w
Reference
2024-109856
Expiry date
01/01/0001
Author
Paula MartinAuthor
Paula Martin