Senior Clinical Research Associate - Midwest / West - Surgical Medical Device
- United States
- Clinical Monitoring
- ICON Strategic Solutions
- Remote
TA Business Partner
- Icon Strategic Solutions
About the role
As a Sr CRA you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
What will you be doing?
- To support 3 protocols in the Surgical Management space
- Demonstrated leadership, through involvement in specific initiatives when needed, and/or SME to systems and/or processes
- Mentors/coaches junior flex team
- Acts as Lead SM-training other SMs on study
- Develops site start up documents for studies including SIV agenda
- Provides SM “voice” when reviewing study documents (e.g. Monitoring Guidelines)
- Represents LTMs or SMs on SMTs/meetings
- Supports country budget development and/or contract negotiation in liaison with CCS colleagues
- Assists with ASV
- Metrics/KPIs: Metrics/KPIs governing these services are outlined in the Quality Oversight Plan (QOP) document.
Interfaces – Primary/Other:
- Primary interfaces: Provider Functional Manager, Clinical Trial Assistant, Local Trial Manager and Central Study Team for assigned clinical trials.
- Other Interfaces: Study Responsible Physician, Regional Quality and Compliance. Manager/Specialist, Local Drug Safety Officer (where required) and Site Manager team; Investigators and their delegates at site (trial personnel including study coordinators, pharmacists, etc.
What do you need to have?
- The ideal candidate will be located in the central to west coast region of the country.
- Bachelor Degree is required, preferably a Bachelor of Science Degree in Life Science, Physical Science, Nursing or Biological Science.
- Have a minimum of 3 years’ experience in monitoring medical device or pharmaceutical industry clinical trials, 5+ preferred.
- Medical Device monitoring preferred; however, strong pharma monitoring experience will be considered in lieu of Med Device experience.
- Analytical/risk-based monitoring experience is an asset
- Ability to actively drive patient recruitment strategies at assigned sites
- Ability to partner closely with investigator and site staff to meet all of our study timelines
- Ability to operate and use various systems and databases (e.g. CTMS, EDC, eTMF, various dashboards/metrics, IWRS, safety reporting).
- Possess strong communication and influencing skills to effectively manage study sites both remotely and face to face. Strong team member and self-starter with the ability to work independently.
- Have an in-depth knowledge of Good Clinical Practice, ICH guidelines and local regulatory requirements.
- Need to travel up to 50%
- To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.
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.
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
![EPIC Interns](https://attraxcdnprod1-freshed3dgayb7c3.z01.azurefd.net/1481126/e40ce6f4-d08e-41da-9b68-65e34e789e42/2023.17000.2380/img/YCINWcHAgU0cSAjbiRzJAw/75/1689869226882.jpeg)
Teaser label
Career ProgressionContent type
BlogsPublish date
07/20/2023
Summary
Unlocking your Potential: The Benefits of ICON’s EPIC Internship Program Internship programs have become a vital stepping stone for students and young professionals seeking to gain practic
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
France
Department
Clinical Monitoring
Location
France
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
2023-106829
Expiry date
01/01/0001
Author
Dominique CarilienAuthor
Dominique CarilienSalary
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
Montreal
Department
Clinical Monitoring
Location
Montreal
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
2024-111436
Expiry date
01/01/0001
Author
Jamie PruittAuthor
Jamie PruittSalary
Location
Montreal
Department
Clinical Monitoring
Location
Montreal
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
2024-111435
Expiry date
01/01/0001
Author
Jamie PruittAuthor
Jamie PruittSalary
Location
Montreal
Department
Clinical Monitoring
Location
Montreal
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
2024-111434
Expiry date
01/01/0001
Author
Jamie PruittAuthor
Jamie PruittSalary
Location
Montreal
Department
Clinical Monitoring
Location
Montreal
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
2024-111431
Expiry date
01/01/0001
Author
Jamie PruittAuthor
Jamie Pruitt