Study Start Up Associate II
Talent Acquisition Business Partner
- Full Service Division
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 II
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
* 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
* Perform regulatory document for initial submission and maintenance e.g. amendments, periodic updates and safety letters.
* Prepare, review, submit and QC submissions to ethics, regulatory and other authorities to obtain clinical trial authorizations and approvals.
* Develop and finalize Country Specific SIS/ ICFs.
* Collect critical documents for IP release
* Mentor / train new and junior personnel in SSU.
* Part of Regulatory Intelligence SME Team.
* 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 Paralegal Studies, Juris Doctor (law) degree, or related experience is preferred
* 1 to 3 year SSU experience is desirable.
* 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.
* Excellent communication in local language and English
Benefits of Working in ICON:
Our success depends on the quality of our people. That's why we've made it a priority to build a culture that rewards high performance and nurtures talent.
We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals - both ours and yours.
We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans - and related benefits such as life assurance - so you can save and plan with confidence for the years ahead.
But beyond the competitive salaries and comprehensive benefits, you'll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.
ICON 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 through the form below.
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
Our PeopleContent type
BlogsPublish date
03/27/2024
Summary
Exploring Lucy's Path: From Science to Communications Lucy's career journey is a testament to the power of adaptability and seizing opportunities as they arise. "I've been in Clinical Research si
Teaser label
Career ProgressionContent type
BlogsPublish date
03/27/2024
Summary
Interviews can be nerve-wracking experiences, but with the right preparation, you can enter the room with confidence and increase your chances of success. Preparing for an interview is crucial a
Teaser label
Career ProgressionContent type
BlogsPublish date
03/27/2024
Summary
Clinical research plays a crucial role in advancing medical knowledge and improving patient care. At the heart of every successful clinical research study is a Clinical Research Coordinator (CRC
Who we are
Similar jobs
Salary
Location
United Kingdom, Germany, France, Spain, Poland
Department
Biometrics Roles
Location
France
Germany
Poland
Spain
UK
Business Area
ICON Strategic Solutions
Job Categories
Clinical Data Management
Clinical Data Scientist Lead
Clinical Systems
Data Standards Consultant
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
2024-109450
Expiry date
01/01/0001
Salary
Location
US, Rocky Mount, NC
Location
Rocky Mount
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Clinical Research Site 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
JR117585
Expiry date
01/01/0001
Author
Stephanie CurranAuthor
Stephanie CurranSalary
Location
US, Blue Bell (ICON)
Department
Full Service - Symphony Health
Location
Blue Bell
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Engineering
Job Type
Permanent
Description
ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotech
Reference
JR116127
Expiry date
01/01/0001
Author
Tallulah PierreAuthor
Tallulah PierreSalary
Location
US, Mt. Pleasant, SC
Location
Mt. Pleasant
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
JR117582
Expiry date
01/01/0001
Author
Stephanie CurranAuthor
Stephanie CurranSalary
Location
India, Bangalore
Department
Full Service - Laboratory
Location
Dublin
Limerick
Bangalore
Bengaluru
Remote Working
Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Sales
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
JR117435
Expiry date
01/01/0001
Author
Moushami RoyAuthor
Moushami RoySalary
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
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
2024-109055
Expiry date
01/01/0001
Author
Melissa BennerAuthor
Melissa Benner