Senior Study Start Up Associate (ANVISA)
- Brazil
- Clinical Monitoring
- ICON Strategic Solutions
TA Business Partner
- Icon Strategic Solutions
About the role
The Sr. Study Start Up Associate fulfills the role of Local Regulatory Affairs Lead (LRAL) and is responsible for preparing, submitting and following up on initial and amended Regulatory Agency (RA), Central Independent Ethics Committee (IEC), and any other central submissions required in the country(s) they are responsible for, within contracted timelines and budget, in accordance with local regulatory requirements and sound scientific/technical principles, including the creation and modification of documentation required for approval.
What you will be doing:
- Manages activities associated with obtaining initial, amendment and other central authority approvals i.e. Regulatory Agency (RA), Central Independent Ethics Committee (IEC) and any other central authorities for the assigned country/countries
- Manages central/country level submissions associated with ensuring Investigational Product (IP) and any other clinical trial supplies can be imported and where applicable, exported into/from the country(s) the associate is responsible for
- Ensures that IP labels are in adherence to country requirements and submitted where applicable
- Manages the central/country level Informed Consent and any other documentation given to patients i.e. diaries, questionnaires through to submission and approval by country level RA
- and Central IEC as appropriate
- Tracks and reports central submission/approval progress in applicable systems
- Performs role of local reviewer in the QC process as appropriate
- Provides consultancy to the client on any country-specific issues if requested by the study start- up or clinical teams
- Attends project team meetings as determined by the start-up or clinical teams
- If applicable for the country, submit expeditable safety reports to RAs and central IECs in accordance with relevant legislation
- Contributes to the maintenance and collection of regulatory intelligence by ensuring that relevant tools and systems are up to date; communicates new information or changes to the regulatory team
- May work with regulatory team members to provide regulatory consulting services
- Maintenance of the accurate, up to date country knowledge repository
- Serve as country consultant for the regulatory team
- Provides mentoring and training for lower level resources
- Supports lower level resources with more complex submissions requirements
- May liaise with team/other department members to validate country intelligence before liaising with the appropriate regulatory team members to ensure that the information is disseminated appropriately
You are:
- Undergraduate degree or its international equivalent in clinical, science, or health related field from an accredited institution or a licensed healthcare professional (i.e. registered nurse) required
- Prior experience preparing ANVISA DDCM submissions
- Expert knowledge of current ICH and local Regulatory Agency and Ethics Committee regulations
- Prior experience using computerized information systems required; experience with PC Windows, word processing, and electronic spreadsheets required
- Read, write, and speak English; fluent in host country language
What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits
At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON 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 through the form below.
https://careers.iconplc.com/reasonable-accommodations
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.
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

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 excell

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
Similar jobs at ICON
Salary
Location
Vietnam
Department
Clinical Monitoring
Location
Vietnam
Business Area
ICON Strategic Solutions
Job Categories
Clinical Monitoring
Job Type
Permanent
Description
Title: CRA II Location: Vietnam, Home-based As an experienced Clinical Research Associate, you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healt
Reference
2025-119745
Expiry date
01/01/0001
Author
Maria ClareAuthor
Maria ClareSalary
Location
Greece
Department
Clinical Monitoring
Location
Greece
Remote Working
Office Based
Business Area
ICON Strategic Solutions
Job Categories
Clinical Monitoring
Job Type
Permanent
Description
As a CTC you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Reference
2025-119345
Expiry date
01/01/0001
Author
Alexander SourounisAuthor
Alexander SourounisSalary
Location
Shanghai
Department
Clinical Monitoring
Location
Shanghai
Remote Working
Office Based
Business Area
ICON Strategic Solutions
Job Categories
Clinical Monitoring
Job Type
Permanent
Description
As a CRA1 you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Reference
2025-120017
Expiry date
01/01/0001
Author
Irena GuoAuthor
Irena GuoSalary
Location
United States
Department
Clinical Monitoring
Location
United States
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
2025-118789
Expiry date
01/01/0001
Author
Jamie PruittAuthor
Jamie PruittSalary
Location
Spain, Madrid
Department
Clinical Monitoring
Location
Lisbon
Barcelona
Madrid
Remote Working
Home or Office
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
JR127665
Expiry date
01/01/0001
Author
Sophie BinghamAuthor
Sophie BinghamSalary
Location
UK, Reading
Department
Clinical Monitoring
Location
Reading
Remote Working
Home or Office
Business Area
ICON Full Service & Corporate Support
Job Categories
Clinical Monitoring
Job Type
Permanent
Description
We are currently seeking a Clinical Research Associate II for our full service team in the UK. As a Clinical Research Associate II at ICON, you will play a pivotal role in designing and analyzing clin
Reference
JR129616
Expiry date
01/01/0001
Author
Sophie BinghamAuthor
Sophie Bingham