CV Bank Site Activation Lead
- United States
- Study Start Up
- ICON Strategic Solutions
- Remote
TA Business Partner
- Icon Strategic Solutions
About the role
The Site Activation Specialist is responsible for site start-up activities for the assigned studies within the Site Alliance and Site Activation Sub-Chapter under Clinical Operations. The position will require strong stakeholder management working closely with Contracting, IVDR, Legal, Privacy, Study Teams, CRO, and Sites.
What you will be doing:
● Responsible for the effective operations and delivery of site activation deliverables across all regions, within the assigned projects.
● Supports the pre-study site identification/selection process for relevant studies through collection and analysis of site feasibility information.
● Maintain regular communications with investigational sites/CRO to ensure timely completion of the required site activation activities/documentation and resolve or escalate issues in a timely manner
● Collect, receive and perform the first review of required study-specific site regulatory/essential documents in accordance with applicable SOPs, guidelines, and study timelines and requirements
● Coordinate Investigator Review Board (IRB)/Ethics Committee (EC)/other relevant regulatory submissions in collaboration with sites/study teams
● Work with sites to ensure informed consent form meets the required regulatory and company requirements.
●Facilitate the translation of essential documents that may be required in languages other than English for the purposes of submission to and approval from Competent Authorities and/or IRB/EC.
● Coordinate the clinical trial insurance process to ensure timely results and support throughout the conduct of the clinical study.
● Support contract and budget negotiations in partnership with Contracting and Study Teams.
● Ensure Purchase orders and Fair Market Value assessments are completed for timely start-start up.
● Support study instrument placements, Obtain import/export licensure
● Support implementation and use of eTools at the site
● Collect and maintain relevant country, local, state, and site-level regulatory intelligence for future use
● Work closely with Study Teams to deliver study start-up tasks.
● Solve identified issues with appropriate timely escalation to the Study Teams
● Support internal audit and external inspection activities; contribute to CAPAs as required.
● May be responsible for other responsibilities as assigned.
You are:
● Associate or Bachelor’s degree in chemistry, biology, other life sciences, or a related field, or equivalent combination of education and experience
● Experience in study start-up is required
● Experience with CRO management is a plus.
● Experience in clinical trial planning, including IRB/Ethics Committee, Competent authority submissions and contracts
● Knowledge of clinical trial methodologies, medical terminology, ICH/GCP
● Must be fluent in English, and the language of the appointed location
● Working knowledge of global and local regulatory requirements (IVDR and other applicable regulations) is a plus.
● Understand the quality expectations and emphasis on the right first time, attention to detail
● Ability to organize tasks, time, and priorities, ability to multi-task
● Required to support multi-national team members, and flexibility in working hours may be needed.
● Participate and work effectively with multiple cross-functional teams
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
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
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
Similar jobs at ICON
Salary
Location
Colombia, Bogota
Location
Sao Paulo
Santiago
Bogota
Mexico City
Lima
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
JR120781
Expiry date
01/01/0001
Author
Olivia MolinaAuthor
Olivia MolinaSalary
Location
Mexico
Department
Study Start Up
Location
Mexico
Remote Working
Office Based
Business Area
ICON Strategic Solutions
Job Categories
Study Start Up
Job Type
Permanent
Description
As a CTA you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Reference
2024-112458
Expiry date
01/01/0001
Author
Rita VillavicencioAuthor
Rita VillavicencioSalary
Location
Latvia, Riga
Location
Zagreb
Riga
Warsaw
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Study Start Up
Job Type
Permanent
Description
Study Start Up Associate ( Clinical Site Activation )Latvia, Croatia, PolandAt ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help
Reference
JR122683
Expiry date
01/01/0001
Author
Emma ScottAuthor
Emma ScottSalary
Location
Bulgaria, Sofia
Location
Sofia
Riga
Vilnius
Bratislava
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Study Start Up
Job Type
Permanent
Description
We are currently seeking a Study Start Up Associate II to join our diverse and dynamic team. As a Study Start Up Associate II at ICON, you will play a pivotal role in leading the initiation of clinica
Reference
JR123680
Expiry date
01/01/0001
Author
Fiona CunliffeAuthor
Fiona CunliffeSalary
Location
India, Bangalore
Department
Study Start Up
Location
Bangalore
Bengaluru
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Feasibility
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
JR123508
Expiry date
01/01/0001
Author
Caroline SweetyAuthor
Caroline SweetySalary
Location
United States
Department
Study Start Up
Location
United States
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Study Start Up
Job Type
Permanent
Description
As a Senior Feasibility Specialist you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.Reporting to the Associate Director o
Reference
2024-114033
Expiry date
01/01/0001