JUMP TO CONTENT

Study Start Up Associate I

045457_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 I /II [ multiple positions ]

Reporting to                             : Manager

Type of Employment            : Full Time

Location                                 : Chennai

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 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

female pharmacist selecting medicine
Careers in Pharmacovigilance: Opportunities in Patient Safety and Drug Development

Teaser label

Industry

Content type

Blogs

Publish date

08/25/2025

Summary

Careers in Pharmacovigilance Pharmacovigilance, also known as drug safety, is one of the most important pillars of modern medicine. It ensures that once a medicine is developed, tested, and appro

Teaser label

Learn the skills that open doors to a career in drug safety and development.

Read more
Headshot of female
Leadership in Mexico: Karen Hahn’s Journey at ICON

Teaser label

Our People

Content type

Blogs

Publish date

08/14/2025

Summary

A Leader’s Journey: Karen Hahn on Growth, Culture and the Future of ICON Mexico Karen Hahn’s career at ICON has unfolded over more than 15 years, shaped not by a rigid plan, but by openness to ch

Teaser label

Over 15 years, Karen Hahn has grown alongside ICON Mexico - from a team of 40 in 2010 to over 2,000 today.

Read more
Headshot of female
Building a Career at ICON: Susie's journey from HR Analyst to Senior VP

Teaser label

Inside ICON

Content type

Blogs

Publish date

08/07/2025

Summary

Building a Career at ICON: A Conversation with Susie McEvoy, Senior VP of HR At ICON, career journeys are rarely linear – and Susie McEvoy’s story is a powerful example of that. From joining as a

Teaser label

Discover how Susie built a successful career at ICON, progressing from HR Analyst to Senior Vice President.

Read more
View all

Similar jobs at ICON

CRA II / Sr. CRA

Salary

Location

US, Blue Bell (ICON)

Department

Clinical Monitoring

Real World Solutions

Location

Blue Bell

Remote Working

Office or Home

Business Area

ICON Full Service & Corporate Support

Job Categories

Clinical Monitoring

Job Type

Permanent

Description

We are currently seeking a Senior Clinical Research Associate (CRA) to join our diverse and dynamic team. As a Senior CRA at ICON Plc, you will play a critical role in overseeing and managing clinical

Reference

JR134544

Expiry date

01/01/0001

Jasmine Garcia Read more Shortlist Save this role
Business Operations Specialist - Patient Engagement

Salary

Location

West Point

Department

Clinical Trial Management

Location

West Point

Remote Working

Office Based

Business Area

ICON Strategic Solutions

Job Categories

Clinical Trial Management

Job Type

Permanent

Description

As a Business Operations Specialist - Patient Engagement you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. Hybrid Role: T

Reference

2025-122082

Expiry date

01/01/0001

Brandon Pupek

Author

Brandon Pupek
Read more Shortlist Save this role
Senior Biostatistician II

Salary

Location

Mexico

Department

Biometrics Roles

Location

Mexico

Remote Working

Home-Based

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 Senior Biostatistician you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. You will be partnering with one of the worl

Reference

2025-122033

Expiry date

01/01/0001

Magda Obregon

Author

Magda Obregon
Read more Shortlist Save this role
Product Manager

Salary

Location

Ireland, Dublin

Department

Information technology

Location

Dublin

Remote Working

Office or Home

Business Area

ICON Full Service & Corporate Support

Job Categories

Product Development

Job Type

Permanent

Description

We are seeking a IT Product Manager to join our IT Business Partnering team:The IT Business Partner Group (BPG) serves as the strategic interface between ICON’s business units and IT to stimulate, sur

Reference

JR126878

Expiry date

01/01/0001

Maya Katsarska Read more Shortlist Save this role
CRA II

Salary

Location

US, Long Beach, CA

Location

Los Angeles

Downers Grove

Long Beach

Remote Working

Office or Home

Business Area

ICON Full Service & Corporate Support

Job Categories

Clinical Monitoring

Job Type

Permanent

Description

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

Reference

JR132451

Expiry date

01/01/0001

Meris Myers

Author

Meris Myers
Meris Myers

Author

Meris Myers
Read more Shortlist Save this role
Financial Analyst II - Project Finance

Salary

Location

Ireland, Dublin

Location

Dublin

Remote Working

Office Based

Business Area

ICON Full Service & Corporate Support

Job Categories

Accounting & Finance

Job Type

Permanent

Description

The successful candidate will provide financial analysis to Operational & Finance management on the historical and current financial performance and future outlook of portfolios of work within the Lar

Reference

JR134270

Expiry date

01/01/0001

Damien Kehir

Author

Damien Kehir
Read more Shortlist Save this role
View Jobs

Browse popular job categories below or search all jobs above