Senior CRA
- Czech Republic
- Clinical Monitoring
- ICON Strategic Solutions
- Remote
TA Business Partner
- Icon Strategic Solutions
About the role
As a Senior Clinical Research Associate, you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
OBJECTIVE:
The Clinical Research Associate (SrCRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The SrCRA works in close collaboration with other CRAs and the Local Study Team to ensure that study commitments are achieved in a timely and efficient manner. The SrCRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure proper delivery of the study.
The SrCRA is responsible for the preparation, initiation, monitoring and closure of assigned sites in clinical studies,
•Contributes to the selection of potential investigators.
•Accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification Visits, collection, preparation, review and
tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study.
• Trains, supports and advises Investigators and site staff in study related matters, including Risk Based Quality Management principles.
• Confirms that site staff have completed and documented the required trainings appropriately, including ICH-GCP training, prior to and for the duration of the study. •Ensures the sites are inspection ready at all times.
• Actively participates in Local Study Team meetings.
• Contributes to National Investigators meetings, as applicable.
•Initiates, monitors and closes study sites in compliance with AZ Procedural Documents. Shares information on patient recruitment and study site progress (site quality/performance) within the local study team.
•Drives performance at the sites. Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate.
•Updates CTMS and other systems with data from study sites as per required timelines.
•Manages study supplies (ISF, etc), drug supplies and drug accountability at study site. Prepares study drug for destruction, if applicable.
•Performs monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Monitoring Plan.
•Performs Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), in accordance with the Monitoring Plan.
•Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study.
•Bachelor degree in related discipline, preferably in life science, or equivalent qualification.
•Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP.
•Good knowledge of relevant local regulations.
•At least 4 years of experience as CRA (mandatory).
•Valid driving licence.
•Ability to travel as required.
Why 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.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.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.
#LI-DD1
#LI-remote
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
![Man with headphones on looking at a laptop](https://attraxcdnprod1-freshed3dgayb7c3.z01.azurefd.net/1481126/e40ce6f4-d08e-41da-9b68-65e34e789e42/2023.17000.2380/img/5Z6C1pGWd01xPgjadgXIBA/75/5+tips+to+make+a+lasting+impression+in+your+video+interview+2+(1).jpg)
Teaser label
Career ProgressionContent type
BlogsPublish date
05/10/2024
Summary
Although many employers are returning to the office, we’re still seeing a mix of both video and in-person interviews in application processes. Early in 2020, the number of companies using video interv
![A picture of Debora Oh](https://attraxcdnprod1-freshed3dgayb7c3.z01.azurefd.net/1481126/e40ce6f4-d08e-41da-9b68-65e34e789e42/2023.17000.2380/img/Oi_Ywfaw1E2c5AjadgdpUA/75/debora-oh-thumbnail.jpg)
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
![A picture of Yemi Moses](https://attraxcdnprod1-freshed3dgayb7c3.z01.azurefd.net/1481126/e40ce6f4-d08e-41da-9b68-65e34e789e42/2023.17000.2380/img/voIjKGzvOUdxWAjadgXIBA/75/yemi-moses-thumbnail.jpg)
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
Who we are
Press play to find out more
![](https://attraxcdnprod1-freshed3dgayb7c3.z01.azurefd.net/1481126/e40ce6f4-d08e-41da-9b68-65e34e789e42/2023.17000.2380/Blob/img/full-width-video.jpg?v=2023.15273-main)
Similar jobs at ICON
Salary
Location
Colombia
Department
Clinical Monitoring
Location
Colombia
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Monitoring
Job Type
Permanent
Description
As the Senior Manager – Pharmacovigilance, you will be responsible for overseeing a large team of PV professionals, for an assigned FSP client program. Reporting into the Director of Clinical Operatio
Reference
2024-110646
Expiry date
01/01/0001
Author
Magda ObregonAuthor
Magda ObregonSalary
Location
Argentina
Department
Clinical Monitoring
Location
Argentina
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Monitoring
Job Type
Permanent
Description
As a Study Start-Up CRA (SSU CRA) will be responsible of creating and endorsing submission packages related to the country or site, following ICH, GCP, and all relevant regulations, laws, guidelines,
Reference
2024-111463
Expiry date
01/01/0001
Author
Tulio SanquizAuthor
Tulio SanquizSalary
Location
Argentina
Department
Clinical Monitoring
Location
Argentina
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Monitoring
Job Type
Permanent
Description
The Clinical Research Associate (CRA) monitors the progress of clinical studies at investigative sites or remotely, ensuring clinical trials are conducted, recorded, and reported in accordance with th
Reference
2024-111456
Expiry date
01/01/0001
Author
Tulio SanquizAuthor
Tulio SanquizSalary
Location
Argentina
Department
Clinical Monitoring
Location
Argentina
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Monitoring
Job Type
Permanent
Description
As a Study Start-Up CRA (SSU CRA) will be responsible of creating and endorsing submission packages related to the country or site, following ICH, GCP, and all relevant regulations, laws, guidelines,
Reference
2024-111462
Expiry date
01/01/0001
Author
Tulio SanquizAuthor
Tulio SanquizSalary
Location
Argentina
Department
Clinical Monitoring
Location
Argentina
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Monitoring
Job Type
Permanent
Description
As a Study Start-Up CRA (SSU CRA) will be responsible of creating and endorsing submission packages related to the country or site, following ICH, GCP, and all relevant regulations, laws, guidelines,
Reference
2024-110681
Expiry date
01/01/0001
Author
Tulio SanquizAuthor
Tulio SanquizSalary
Location
Argentina
Department
Clinical Monitoring
Location
Argentina
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Monitoring
Job Type
Permanent
Description
The Clinical Research Associate (CRA) monitors the progress of clinical studies at investigative sites or remotely, ensuring clinical trials are conducted, recorded, and reported in accordance with th
Reference
2024-110560
Expiry date
01/01/0001
Author
Tulio SanquizAuthor
Tulio Sanquiz