Study Start-Up Associate II
- Argentina
- Clinical Monitoring
- ICON Strategic Solutions
- Remote
TA Business partner
- Icon Strategic Solutions
About the role
This vacancy has now expired. Please see similar roles below...
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 accordance with the Sponsor and/or PRA protocol, standard operating procedures (SOPs), ICH/GCP guidelines and all applicable regulatory requirements. At the Senior level, the Study Start Up Associate will manage and lead all activities listed above and will ensure that all activities meet Sponsor and PRA expectations and are delivered in accordance with the contract, trial protocol, ICH/GCP and applicable SOPs.
- Performs investigator recruitment activities utilizing phone scripts, questionnaires, study site materials and other tools for use in evaluating investigative sites.
- Utilizes the Clinical Trial Management System (the CTMS) to ensure investigator recruitment activities are accurately tracked.
- Performs essential document collection, review, maintenance and close-out activities, ensuring that sponsor and investigator obligations are being met and are in compliance with applicable local regulatory requirements and ICH/GCP guidelines.
- Supports investigators and investigative staff in fulfilling obligations with regard to local submissions according to local regulatory and Institution Review Board (IRB)/Independent Ethics Committee (IEC) requirements.
- Performs study tracking via the CTMS or Sponsor designated system to ensure that the study files are current, accurate and complete.
- Documents site and Sponsor contact and study interactions in a timely and professional manner.
- Assists with resolution of investigational site/data queries.
- Liaises with project team members regarding study site issues.
- Provides quality review of the informed consent template.
- Performs study duties in adherence to the protocol, Clinical Management Plan (CMP), study processes, ICH-GCP and any other requirements stipulated on the study.
- Follows up with sites for trial invoices and ensures the CTMS is accurately updated to allow the timely processing of Investigator Payments.
- Performs other duties as assigned.
• Bachelor’s degree in a health, life sciences or medical fields.
• At least 1 year of experience with study start-up activities in clinical research market.
• Fluent English and Spanish (read, write and speak)
• Candidates must be based in CABA.
Why ICON?
At ICON, we embrace new perspectives and empower our people to write their own paths forward. We are a culturally diverse company with over 40,000 talented and ambitious people with varied skills, perspectives & backgrounds working together across 40 countries.
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.
At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
ICON, including subsidiaries, 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, colour, 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.
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
A better career. A better world. A better you.
Our people are our greatest strength, are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers, deliver results to help bring life-changing medicine and devices to market and maintain ICON’s success as an industry leader. See all locations Read more
Day in the life
Teaser label
Our PeopleContent type
BlogsPublish date
08/29/2023
Summary
To excel as a Clinical Research Associate (CRA) in a Clinical Research Organization (CRO), you need a combination of education, skills, and the right mindset. Brazil-based CRA II Debora shares her
Teaser label
Our PeopleContent type
BlogsPublish date
05/23/2023
Summary
How to progress as a Clinical Research AssociateTo thrive as a Clinical Research Associate (CRA), it is imperative to cultivate a multifaceted skill set and demonstrate unwavering commitment to exce
Teaser label
A Day In The LifeContent type
BlogsPublish date
04/05/2023
Summary
Senior Clinical Research Associate Suzaita Hipolito talks about the satisfaction gained from working in Clinical Research. “What would it look like to wake up every day feeling happy and fulfilled?
by
Suzaita Hipolito
Who we are
Similar jobs at ICON
Salary
Location
US, Blue Bell (ICON)
Department
Clinical Monitoring
Real World Solutions
Location
Blue Bell
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Clinical Monitoring
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
JR117796
Expiry date
01/01/0001
Author
Zach HinesAuthor
Zach HinesSalary
Location
US, Brentwood, TN
Department
Full Service - Development & Commercialisation Solutions
Location
Brentwood
Raleigh
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Clinical Monitoring
Job Type
Permanent
Description
Requirements:Must be located within the United StatesMust have 12+ months of independent monitoring experience as a CRAAt ICON, it’s our people that set us apart. Our diverse teams enable us to become
Reference
JR118459
Expiry date
01/01/0001
Author
Sarah WoodAuthor
Sarah WoodSalary
Location
Argentina
Department
Clinical Monitoring
Location
Argentina
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Monitoring
Job Type
Permanent
Description
As Clinical Research Associate (CRA), you will be joining the world's largest & most comprehensive clinical research organization, powered by healthcare intelligence. A CRA is a professional who cont
Reference
2023-103904
Expiry date
01/01/0001
Author
Tulio SanquizAuthor
Tulio SanquizSalary
Location
Turkey
Department
Clinical Monitoring
Location
Turkey
Business Area
ICON Strategic Solutions
Job Categories
Clinical Monitoring
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
2024-110128
Expiry date
01/01/0001
Salary
Location
Australia
Department
Clinical Monitoring
Location
Australia
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Monitoring
Job Type
Permanent
Description
Lead Clincial Research Associate (FSP)Location: Home-based, Australia As a Lead CRA, you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare
Reference
2024-109668
Expiry date
01/01/0001
Author
Joanne YoungAuthor
Joanne YoungSalary
Location
Seoul
Department
Clinical Monitoring
Location
Seoul
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Monitoring
Job Type
Permanent
Description
As a (CRA II, SCRA) you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Reference
2024-110100
Expiry date
01/01/0001
Author
Sonia OhAuthor
Sonia Oh