JUMP TO CONTENT
Shortlist
search jobs Search
About the role ICON and you Application Process Day in the life Who we are

Study Start Up Associate I - Italy

016266_2

About the role

This vacancy has now expired. Please see similar roles below...

Study Start Up Associate
 
The Study Start Up Associate is responsible for the preparation and approval of country related submission packages in accordance with ICH, GCP and all applicable regulations, laws and other guidelines and ethical standards – within specific timelines and quality standards.  Also responsible for the 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.
 
Job Functions and Responsibility
  • Perform feasibility, site identification, site contract negotiation, and other study start up activities, as assigned.
  • Prepare, review and submit submissions to ethics and regulatory and other relevant authorities in order to obtain all necessary authorizations/approvals pertaining to the clinical trial conduct.
  • Develop and finalize Country Specific SIS/ ICFs.
  • Prepare and finalize Country Specific xml files (if applicable for region).
  • Review and translate Drug Labels
  • Perform independent quality review of submission packages.
  • Collect and maintain current Regulatory/Competent Authority (CA) and Ethics Committee (EC) submission information, and similar information for other related organizations, for the assigned countries and update relevant ICON information system.
  • Responsible for the translation and co-ordination of translations for documents required for submission (if applicable for region).
  • Perform timely and accurate data entry of regulatory documents, submission status and maintenance of Country/Investigator information in 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 CA/EC.
  • Responsible for the collection of critical documents required for IP Release.
  • Attend study team meetings as required.
  • Assemble and distribute study materials to Clinical and Project teams, including materials to study sites and Investigator Meetings (e.g.; investigator binders) and vendors, as appropriate.
  • Be familiar with ICH GCP, relevant country regulations/guidelines and ICON SOPs.
  • Assist and provide support to the Study Start Up Lead to maximize submission effectiveness, minimize timelines and ensure sponsor satisfaction.
  • Undertake other reasonably related duties as may be assigned from time to time.
  • Travel (approximately 5%) domestic and/or international.  Anticipated activities may include attendance at Kick-Off, Investigator or study team meetings
Experience Skills and Knowledge Required
 
  • Prior relevant experience and/or understanding of clinical study start up requirements and activities.
  • Good organizational skills and the ability to manage multiple tasks.
  • An excellent level and proven experience of high standards of attention to detail.
  • Good written and verbal communication skills.  Proficient in English and language required for country assignments.
  • Ability to be customer focused is essential.
  • Logical and critical thinking skills.
  • Competent computer skills.
  • Due to the nature of this position it may be required for the employee to travel.  Therefore, dependent on the employee’s location, the employee may be required to possess a valid Driver’s license.
Education Requirements
High School diploma, or local equivalent, required.  Bachelors degree, or local equivalent, preferred.
 
*LI-AC1. 
List #1

Day in the life

Mission, vision, Values
Home Sweet Office: Why Culture Compatibility Matters

Teaser label

Inclusion & Belonging

Content type

Blogs

Publish 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

Explore how aligning with the right company culture can transform your work environment into a home away from home.

Read more
Medicine container
Precision Medicine: How Personalised Therapies are Transforming Healthcare

Teaser label

Industry

Content type

Blogs

Publish 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

Discover how precision medicine is revolutionising healthcare by tailoring treatments to each patient.

Read more
Headshot of Deepak, the author of this blog
Day in the life of a Clinical Data Mangement Project Manager

Teaser label

Our People

Content type

Blogs

Publish 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

Teaser label

Deepak shares his experience as Clinical Data Management Project Manager at ICON Strategic Solutions.

Read more
View all

Who we are

Press play to find out more

Similar jobs at ICON

Clinical Sample Processor I

Salary

Location

US, New York, NY, Farmingdale

Department

Full Service - Development & Commercialisation Solutions

Location

Farmingdale

Remote Working

Office Based

Business Area

ICON Full Service & Corporate Support

Job Categories

Clinical Supplies

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

JR118493

Expiry date

01/01/0001

Zach Hines

Author

Zach Hines
Zach Hines

Author

Zach Hines
Read more Shortlist Save this role
Read more Shortlist Save this role
Senior Clinical Research Associate- CA/AZ

Salary

Location

United States

Department

Clinical Monitoring

Location

United States

Remote Working

Remote

Business Area

ICON Strategic Solutions

Job Categories

Clinical Monitoring

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

2024-109974

Expiry date

01/01/0001

Melissa Benner

Author

Melissa Benner
Melissa Benner

Author

Melissa Benner
Read more Shortlist Save this role
Read more Shortlist Save this role
Regional Clinical Scientist - Home-Based (US or Canada)

Salary

Location

United States, Canada

Department

Clinical Trial Management

Location

Canada

United States

Remote Working

Remote

Business Area

ICON Strategic Solutions

Job Categories

Clinical Trial Management

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

2024-110154

Expiry date

01/01/0001

Read more Shortlist Save this role
Read more Shortlist Save this role
Laboratory Assistant

Salary

Location

US, New York, NY, Farmingdale

Department

Full Service - Development & Commercialisation Solutions

Location

Farmingdale

Remote Working

Office Based

Business Area

ICON Full Service & Corporate Support

Job Categories

Laboratory Support

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

JR118524

Expiry date

01/01/0001

Zach Hines

Author

Zach Hines
Zach Hines

Author

Zach Hines
Read more Shortlist Save this role
Read more Shortlist Save this role
Set Up Specialist

Salary

Location

US, New York, NY, Farmingdale

Department

Full Service - Development & Commercialisation Solutions

Location

Farmingdale

Raleigh

Blue Bell

Remote Working

Office Based

Business Area

ICON Full Service & Corporate Support

Job Categories

Clinical Project Management

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

Reference

JR118152

Expiry date

01/01/0001

Zach Hines

Author

Zach Hines
Zach Hines

Author

Zach Hines
Read more Shortlist Save this role
Read more Shortlist Save this role
Medical Technologist I

Salary

Location

US, New York, NY, Farmingdale

Department

Full Service - Development & Commercialisation Solutions

Location

Farmingdale

Remote Working

Office Based

Business Area

ICON Full Service & Corporate Support

Job Categories

Laboratory

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.           

Reference

JR117747

Expiry date

01/01/0001

Zach Hines

Author

Zach Hines
Zach Hines

Author

Zach Hines
Read more Shortlist Save this role
Read more Shortlist Save this role

Browse popular job categories below or search all jobs above