Study Start Up Associate II
Talent Acquisition Business Partner
- Full Service Division
About the role
This vacancy has now expired. Please click here to view live vacancies.
This is an exciting opportunity to work within a fast paced, busy environment for a leading global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. As a SSU 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 and ethical standards Also responsible for the independent preparation, review and approval of site level critical documents for Investigational Product (IP) release in accordance with regulatory/sponsor requirements - within specific timelines and quality standards. Developing and finalizing Master and Country Specific Information Sheets/Informed Consent Forms (SIS/ICFs)
Role Summary
Serving as a primary contact for investigators and research coordinators, you will perform EC & CA submissions, site contract negotiations and other assigned study startup activities. This will include the preparation, review and approval of country related ethics/regulatory submission packages and site level critical documents for Investigational Product (IP) release. Some travel is anticipated, to attend Kick-Off, Investigator and/or study team meetings..
Role Responsibility
* Perform site contract negotiations, and other study start up activities, as assigned
* Provide country specific Study Start Up expertise to Study Start Up Team Leads and project teams.
* Responsible for the preparation and coordination of submissions to regulatory, ethics and other bodies
* Develop, finalize and review Master and Country Specific Subject Information Sheets/Informed Consent Forms (SIS/ICFs)
* Review Drug labels
* Perform independent quality review of submission packages.
* Responsible for the translation and co-ordination of translations for documents required for submissions.
* Perform timely and accurate data entry of all relevant Study Start Up activities into the appropriate clinical trial management system
* Copy and route incoming correspondence, internal documentation, etc., as appropriate
* Responsible for the timely follow-up for queries made by EC/CA
* Responsible for the collection of critical documents required for IP Release
* Responsible for the timely and accurate data entry of all relevant Study Start Up activities into the appropriate clinical trial management system in assigned countries Responsible for the collection and maintenance of the current Regulatory/Competent Authority (CA)and Ethics Committee (EC) submission information, and similar information for other related.
* Develop and maintain effective relationships with local, regional and country authorities
* Comply with all department requirements regarding information provision and status updating and reporting
* Travel(approximately 15%) domestic and/or international. Anticipated activities may include attendance at Bid Defences, Kick-Off, Investigator or study team meetings.
Experience and Qualification
* A minimum of 2 years of hands on experience in Clinical Study Start-up area
* Knowledge and experience in the clinical study start up requirements and activities for all assigned countries (or the ability to find this out for new countries)
* Good organizational skills and the ability to manage multiple tasks
* An excellent level and proven experience high standards of attention to detail
* Good written and verbal communication skills. Proficient in English and local language required for country assignments
* Ability to liaise with colleagues from Study Start Up, other departments and clients, if required
* Strong project management skills
* Highly developed problem solving skills
* Strong people management and effective communication skills
* Customer service focused
* Solution-focused
* Bachelor's Degree or local equivalent and/or with appropriate experience from the Medical/science background and/or discipline
Impactful work. Meaningful careers. Quality rewards.
At ICON, our employees are our greatest strength. That’s why we are committed to empowering you to live your best life, both inside and outside of work. Whether your ambition is lead a global team, become a deep scientific or technical expert, work in-house with our customers or gain experience in a variety of different ICON functions, we will support you in realising your full potential. See all locations Learn more about Our Culture at ICON
Day in the life
.png)
Teaser label
IndustryContent type
BlogsPublish date
07/07/2025
Summary
Precision at the Outset: The Strategic Role of Site Selection and Activation in Clinical Trials The success of any clinical trial begins well before the first patient is enrolled. Behind every sit
.png)
Teaser label
IndustryContent type
BlogsPublish date
07/04/2025
Summary
Cybersecurity in Clinical Data Management In clinical research, data is both a vital asset and a significant responsibility. As trials become increasingly digitised and decentralised, the protectio
.png)
Teaser label
IndustryContent type
BlogsPublish date
07/03/2025
Summary
Finding the Specialisation for You Clinical research is a dynamic, multidisciplinary field that brings together scientific innovation, operational rigour and patient-centric thinking. While many
Similar jobs at ICON
Salary
Location
Mexico City
Department
Regulatory, Drug Safety/ Quality Assurance & Other roles
Location
Mexico City
Remote Working
Home-Based
Business Area
ICON Strategic Solutions
Job Categories
Drug Safety
Job Type
Permanent
Description
We are currently seeking a Pharmacovigilance Associate to join our diverse and dynamic team. As a Pharmacovigilance Associate at ICON, you will play a vital role in monitoring and ensuring the safety
Reference
2025-120926
Expiry date
01/01/0001
Author
Rita VillavicencioAuthor
Rita VillavicencioSalary
Location
US, San Antonio, TX, IDS
Location
San Antonio
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Early Phase Services
Job Type
Permanent
Description
We are currently seeking a Research Assistant to join our diverse and dynamic team. As a Research Assistant at ICON, you will support the design, execution, and management of clinical trials and resea
Reference
JR132551
Expiry date
01/01/0001
Author
Stephanie CurranAuthor
Stephanie CurranSalary
Location
Argentina
Department
Clinical Operations Roles
Location
Argentina
Remote Working
Home-Based
Business Area
ICON Strategic Solutions
Job Categories
Clinical Trial Support
Job Type
Permanent
Description
The Study Start-Up Associate (SSUA) performs investigative site recruitment/feasibility, essential document collection and review, clinical status tracking, and in-house site management activities in
Reference
2025-120928
Expiry date
01/01/0001
Author
Tulio SanquizAuthor
Tulio SanquizSalary
Location
Chicago, United States
Department
Clinical Monitoring
Location
Chicago
United States
Remote Working
Home-Based
Business Area
ICON Strategic Solutions
Job Categories
Clinical Monitoring
Job Type
Permanent
Description
As a Senior Clinical Research Associate you will be joining the world’s largest & most comprehensive clinical research organization, powered by healthcare intelligence.
Reference
2025-120826
Expiry date
01/01/0001
Author
Monica HawkinsAuthor
Monica HawkinsSalary
Location
New York, United States
Department
Clinical Monitoring
Location
New York
United States
Remote Working
Home-Based
Business Area
ICON Strategic Solutions
Job Categories
Clinical Monitoring
Job Type
Permanent
Description
As a Senior Clinical Research Associate you will be joining the world’s largest & most comprehensive clinical research organization, powered by healthcare intelligence.
Reference
2025-120825
Expiry date
01/01/0001
Author
Monica HawkinsAuthor
Monica HawkinsSalary
Location
Chicago
Department
Clinical Monitoring
Location
Chicago
Remote Working
Home-Based
Business Area
ICON Strategic Solutions
Job Categories
Clinical Monitoring
Job Type
Permanent
Description
As a Clinical Research Associate you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Reference
2025-119487
Expiry date
01/01/0001
Author
Monica HawkinsAuthor
Monica Hawkins