Site Activation and Maintenance Associate I
- United States
- Study Start Up
- ICON Strategic Solutions
About the role
This vacancy has now expired. Please see similar roles below...
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, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.
Responsibilities
- Initiate investigator site activities, including:
- collection and submission of regulatory documents
- customization and negotiation of informed consent form (ICF) documents
- serve as the point of contact for a site’s institutional review board (IRB)
- track and ensure site compliance to required training
- Study regulatory maintenance activities including, but not limited to:
- Informed Consent Form (ICF) updates resulting from amendments and addenda, IB/Risk profile changes, etc.
- Management of site changes:
- Personnel (PI, Sub-I, Study Coordinators, etc.)
- Location
- Site-specific recruitment, patient facing material, and patient reimbursement
- Effectively drive timelines aligned with company priorities. Communicate directly with sites to enable start-up and maintain an active collaboration with sites
- Identify, communicate, and resolve issues
- Ensure country specific regulatory and data privacy requirements are incorporated into submission documents and any other documents/systems
- Leverage previous site / review board engagements to efficiently drive new work
- Populate internal systems to ensure accuracy of trial / site performance
- Populate Trial Master Files and libraries for future reference
- Provide feedback and shared learning for continuous improvement
- Leverage trial prioritization
- Anticipate and monitor dynamically changing priorities
Qualifications
- Bachelor’s degree preferably in a scientific or health related field, two years clinical research experience or relevant experience preferred
- Understanding of the overall clinical development paradigm and the importance of efficient site activation
- Applied knowledge of project management processes and skills
- Appreciation of / experience in compliance-driven environment
- Effective communication, negotiation, and problem-solving skills
- Self-management and organizational skills
- Management of roughly 25-30 sites in regulatory activation per FTE
Benefits of Working in ICON:
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, color, 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.
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
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
Teaser label
Our PeopleContent type
BlogsPublish date
02/28/2023
Summary
John Bailey, one of ICON's Veteran Leadership Transition Program Alumni shares his path from serving in the armed forces to joining the clinical research industry. ICON's Veteran Leadership Transit
by
John Bailey
Teaser label
Career ProgressionContent type
BlogsPublish date
12/21/2022
Summary
Salary expectations used to be something discussed after an interview process but now it’s something most recruiters typically ask within the first conversation. This is to ascertain if the remune
by
Jamie Kempski
Who we are
Similar jobs at ICON
Salary
Location
US, Blue Bell (ICON)
Location
Boston
Brentwood
Cary
Farmingdale
Lexington
Portland
Whitesboro
Raleigh
Winston-Salem
Knoxville
Charlotte
Mt. Pleasant
Hickory
Rocky Mount
Bristol
Salisbury
Downers Grove
McFarland
Blue Bell
Piedmont
Rochester
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Site Activation
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
JR119529
Expiry date
01/01/0001
Author
Kris CostelloAuthor
Kris CostelloSalary
Location
Turkey, Ankara
Location
Ankara
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Study Start Up
Job Type
Permanent
Description
Study Start Up Associate IIAt 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
Reference
JR118192
Expiry date
01/01/0001
Author
Andreia SilvaAuthor
Andreia SilvaSalary
Location
Brazil
Department
Study Start Up
Location
Brazil
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Study Start Up
Job Type
Permanent
Description
The Study Start Up. Assocate II, collect, prepare, review, approve, process and track regulatory and site level critical documents required for study site activation in accordance with ICON SOPs/WPs,
Reference
2024-110160
Expiry date
01/01/0001
Author
Bruna DuarteAuthor
Bruna DuarteSalary
Location
Mexico City
Department
Study Start Up
Location
Mexico City
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Study Start Up
Job Type
Permanent
Description
The Study Start Up. Assocate II, collect, prepare, review, approve, process and track regulatory and site level critical documents required for study site activation in accordance with ICON SOPs/WPs,
Reference
2024-110080
Expiry date
01/01/0001
Author
Rita VillavicencioAuthor
Rita VillavicencioSalary
Location
Philippines, Manila
Location
Manila
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Study Start Up
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
JR116204
Expiry date
01/01/0001
Author
Jennifer KimAuthor
Jennifer KimSalary
Location
Germany, Frankfurt
Location
Sofia
Frankfurt
Budapest
Warsaw
Bucharest
Reading
Swansea
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Study Start Up
Job Type
Permanent
Description
Study Start-Up Associate I - Fluent in German and EnglishOffice Based - HybridAt ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and he
Reference
JR119388
Expiry date
01/01/0001
Author
Andreia SilvaAuthor
Andreia Silva