JUMP TO CONTENT

Study Start Up Associate II

045461_2

About the role

This vacancy has now expired. Please click here to view live vacancies.

“At ICON, it's our People that set us Apart”

 

Are you passionate about improving the quality of human life? If so, we invite you to join us in creating a healthier world tomorrow.

 

ICON is a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. We specialize in the strategic development, management and analysis of programs that support Clinical Development - from compound selection to Phase I-IV clinical studies.

 

We started as a team of 5 members in 1990 & today we are ranking at top 4 worldwide based on revenue of 2015. Currently we have 12200+ employees across the globe. ICON is a $1.575bn company having its presence across 89 offices in 37 countries.

 

Job Title                               : Study start up associate

Reporting to                      : Manager

Type of Employment     : Full Time

Location                               : Chennai/Trivandrum

 
Summary:
 

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.  

 
Key Responsibilities/Qualification/Experience
 

SSUA Contract and Budgets

 

As a study start up associate at ICON working in contracts and budgets team, your main role would be to review and negotiate clinical site investigator contracts and budgets.  You would maintain communication with Investigative sites, sponsors and internal teams regarding the status of contracts and contract-related documents, prepare and/ or oversee preparation of contractual documents and correspondence, and facilitate the indemnification process between the study sponsor and the site.  Further you would serve as the internal point of contact on study budgets with respect to investigator payments, develop and update training documentation and conduct group training as necessary, mentor and train new and junior personnel in the study start up department, and act as a point of contact on the Investigator Contract and Budget development process from origination through execution.    

 

We are looking for associates who have experience in a clinical research environment with specific experience in study contracts review and budget negotiation or experience in a related field such as where contract or legal document review was a primary function.  

 

Qualification: A bachelor’s degree in Paralegal Studies, Juris Doctor (law) degree, or related experience is preferred.  Study start up experience is desirable but not mandatory.  

Experience: 3 + years
 
 
 
 
 

SSUA Regulatory submissions

 

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 includes independent preparation, review and approval of site level essential documents for investigational 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 will 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. 

 

Qualification: We prefer someone with a bachelor’s degree and a clinical background with strong clinical site management/ study start up experience. Experience collecting and submitting regulatory documents and communicating with investigative sites is preferred. 

Experience: 3+ years
 
 
 
 
SSUA ICD Review
 

As a Study Start Up Associate at ICON working as an Informed Consent Form Reviewer your main role would be to review Informed Consent Forms and negotiate language as needed.  You will assist in the drafting of ICF country templates for the United States and Canada, which will then be distributed to study sites to make edits depending on their local IRB requirements and SOPs. You will review and negotiate these changes and potentially liaise with other stakeholders like the sponsor, legal, or the clinical team to ensure that changes to the ICF are acceptable.

 

Qualification: We prefer someone with a bachelor’s degree and a clinical background in clinical research at a CRO, Pharmaceutical company, study site, or who has worked in an IRB. Your experience must include performing ICF review as an essential function of the job. 

Experience: 3+ years
 
 
 
 
Benefit Working with ICON:
 

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 pension scheme, private health care, and life assurance and staff recognition schemes. This varies from country to country so a dedicated recruiter will discuss this with you at interview stage. 

 
 
 
PROCESS
 
Technical and competency selection:
 

When you spot an opportunity you’re interested in and submit an application, one of our Talent Acquisition Specialists will contact you to evaluate your suitability for this position, as well as for other openings within the business.

The evaluation will look at your technical skills and your competencies – for example, delivering excellence.

 
Interview
 

After this, we’ll let you know if we’ll be progressing with your application. If you have been successful at this stage, we will talk you through a telephone interview. This will then be followed by an interview with our Hiring Manager, either face to face or by tele-conference.

 
Offer
 

If you’re successful, we will notify you with details of the offer, talk you through our culture and values, answer any questions you may have – and above all, welcome you to the ICON team.

 
 
 
List #1

Day in the life

People talking in a meeting
Networking Strategies in Clinical Research

Teaser label

Industry

Content type

Blogs

Publish date

06/06/2025

Summary

Building Connections that Drive Progress In an industry where collaboration is critical to advancing science and improving patient outcomes, networking is more than a professional courtesy - it’s

Teaser label

Discover how strategic networking can strengthen collaboration, and support your clinical research career journey.

Read more
Blood cancer cells
Blood Cancer Day - Raising Awareness and Driving Change

Teaser label

Industry

Content type

Blogs

Publish date

05/29/2025

Summary

Blood Cancer Day Blood Cancer Day is a powerful reminder of the millions of individuals and families whose lives are affected by hematological malignancies every year. These diseases are complex,

Teaser label

Learn how clinical research is transforming the future for those affected by hematological cancers.

Read more
Silver ribbon
Recognising World Schizophrenia Day through Research and Compassion

Teaser label

Industry

Content type

Blogs

Publish date

05/22/2025

Summary

World Schizophrenia Awareness Day 2025 Every year on 24 May, World Schizophrenia Awareness Day offers a vital opportunity to raise awareness, dismantle stigma, and celebrate the strength of individ

Teaser label

Explore how ICON is advancing schizophrenia research and addressing stigma through clinical innovation.

Read more
View all

Similar jobs at ICON

Regulatory Scientist

Salary

Location

Georgia, Tbilisi

Location

Tbilisi

Business Area

ICON Full Service & Corporate Support

Job Categories

Regulatory Affairs

Job Type

Permanent

Description

Job Responsibilities: • Recognize, exemplify and adhere to ICON's values which centre around our commitment to People, Clients and Performance • As a member of staff, the employee is expected to embra

Reference

JR131117

Expiry date

01/01/0001

Maya Katsarska Read more Shortlist Save this role
Senior Global Regulatory Scientist

Salary

Location

Poland, Warsaw

Department

Full Service - Regulatory

Location

Sofia

Warsaw

Johannesburg

Business Area

ICON Full Service & Corporate Support

Job Categories

Regulatory Affairs

Job Type

Permanent

Description

Job Responsibilities:• Ensuring regulatory deliverables are performed in accordance with all relevant regulations, guidelines, policies and procedures within contractual timelines and budget with soun

Reference

JR129985

Expiry date

01/01/0001

Maya Katsarska Read more Shortlist Save this role
Specialist, Global Site Agreements

Salary

Location

West Point

Department

Clinical Operations Roles

Location

West Point

Remote Working

Remote

Business Area

ICON Strategic Solutions

Job Categories

Contracts Administration

Job Type

Permanent

Description

As a Global Site Agreements Specialist you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Reference

2025-119035

Expiry date

01/01/0001

Brandon Pupek

Author

Brandon Pupek
Read more Shortlist Save this role
Global Clinical Trial Manager

Salary

Location

United States

Department

Clinical Trial Management

Location

United States

Business Area

ICON Strategic Solutions

Job Categories

Clinical Trial Management

Job Type

Permanent

Description

As a Global 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

2025-119999

Expiry date

01/01/0001

Jonathan Holmes Read more Shortlist Save this role
Biostatistician II

Salary

Location

India

Department

Biometrics Roles

Location

India

Remote Working

Remote

Business Area

ICON Strategic Solutions

Job Categories

Statistics

Job Type

Permanent

Description

As a Biostatistician II you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Reference

2025-118705

Expiry date

01/01/0001

Himangshu Skekhar Das Read more Shortlist Save this role
CRA II/ Senior CRA

Salary

Location

Croatia, Zagreb

Department

Clinical Monitoring

Location

Zagreb

Business Area

ICON Full Service & Corporate Support

Job Categories

Clinical Monitoring

Job Type

Permanent

Description

We are currently seeking a Clinical Research Associate II Specialist to join our diverse and dynamic team. As a Clinical Research Associate II Specialist at ICON, you will play a pivotal role in desig

Reference

JR131344

Expiry date

01/01/0001

Tereza Svobodova Read more Shortlist Save this role
View Jobs

Browse popular job categories below or search all jobs above