Study Start Up Associate I
hace 4 semanas
The Study Start Up Associate I at Icon is responsible for collecting, preparing, reviewing, approving, processing, and tracking regulatory and site-level critical documents required for study site activation in accordance with ICON SOPs/WPs, Sponsor SOPs, applicable country regulations/guidelines, and the principles of ICH/GCP.
Key responsibilities include:
- Preparing, reviewing, and approving Subject Information Sheets (SIS) and Informed Consent Forms (ICF)
- Negotiating Informed Consent Forms (ICF) with Study Sites to ensure the Site Specific ICF meets local requirements and contains all required elements from Country Master ICF
- Proficiently reviewing, negotiating, and approving all Ethics Committee (EC), Institutional Review Board (IRB), and Competent Authority (CA) queries to Country and Site Specific ICFs
- Negotiating and executing Clinical Trial Agreements (CTA)
- Establishing and maintaining effective and proactive communication with Study Sites, Sponsors, and internal personnel regarding the status of budgets, contracts, and any other contract-related documents
As a Study Start Up Associate I, you will work closely with key stakeholders to optimize performance and collaborate to ensure successful project outcomes. You will also assume responsibility as a Subject Matter Expert (SME) as required.
Icon is committed to delivering high-quality services to our clients, and we are seeking a highly skilled and detail-oriented individual to join our team as a Study Start Up Associate I.
-
Senior Study Start Up Associate
hace 4 semanas
Xico, México Icon Plc A tiempo completoStudy Start Up Associate RoleAt ICON plc, we're seeking a highly skilled Study Start Up Associate to join our dynamic team. As a key member of our Study Start Up Team, you will be responsible for supporting the development and execution of country and site distribution plans.Key Responsibilities:Efficiently drive study initiation by reviewing and negotiating...
-
Study Start Up Associate II
hace 4 semanas
Xico, México Icon A tiempo completoAt ICON, our diverse teams enable us to become a better partner to our customers and help us to fulfill our mission to advance and improve patients' lives.We are seeking a Study Start Up Associate II to play an integral role in making sure that physicians at our research sites are prepared to start the trial of investigational, new pharmaceutical and...
-
Senior Study Start-Up Associate
hace 3 semanas
Xico, México Icon Plc A tiempo completoAt ICON, Our People Make a DifferenceICON is a world-leading healthcare intelligence and clinical research organization. Our diverse teams enable us to become a better partner to our customers, helping us to advance and improve patients' lives.The Role:- To review and negotiate clinical site investigator contracts and budgets.- Stay connected with...
-
Study Start Up Associate II
hace 4 semanas
Xico, México Icon Plc A tiempo completoAt ICON plc, we advance clinical research by providing outsourced services to pharmaceutical, biotechnology, medical device, and government and public health organizations.Our diverse teams enable us to become a better partner to our customers and help us to fulfill our mission to advance and improve patients' lives.We are committed to developing our...
-
Global Clinical Study Start-up Coordinator
hace 4 días
Xico, México Abbvie A tiempo completoAbout the RoleWe are seeking an experienced Global Clinical Study Start-up Coordinator to join our AbbVie team. In this role, you will be responsible for proactively driving and executing all start-up and maintenance related activities and deliverables for assigned studies and sites in your designated country or countries.
-
Country Study Start Up Specialist
hace 1 mes
Xico, México Abbvie A tiempo completo**Job Summary**:Abbvie is seeking a highly skilled Country Study Start Up Specialist to proactively drive and execute all start up and maintenance related activities and deliverables for assigned studies and sites in their assigned country or countries.**Key Responsibilities**:Ensure successful and on-time execution of start-up and maintenance activities for...
-
Area Study Start Up Manager
hace 4 semanas
Xico, México Abbvie A tiempo completoJob SummaryThe Area Study Start Up Lead will be responsible for the on-time, budget and quality delivery and execution of the start-up and maintenance activities of the assigned pipeline and Global Medical Affairs clinical studies within area. This role reports into the Area SSU Head and serves as a single point of accountability across the area for the...
-
Clinical Research Coordinator
hace 6 días
Xico, México Icon A tiempo completoAbout ICONAt 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.We're driven by four key values: Accountability & Delivery, Collaboration, Partnership and Integrity. These values bring us together as individuals and set us...
-
Clinical Research Associate
hace 4 semanas
Xico, México Icon A tiempo completoStudy Start Up Associate I Role OverviewAt ICON, we're seeking a highly skilled Study Start Up Associate I to join our dynamic team. As a key member of our regulatory submissions team, you will play a pivotal role in facilitating the initiation of clinical trials, ensuring compliance with regulatory requirements, and contributing to the advancement of...
-
Study Coordinator
hace 4 semanas
Xico, México Icon Plc A tiempo completoAbout the RoleWe are seeking a highly organized and detail-oriented individual to join our team as a Study Coordinator. In this role, you will play a key part in assisting the team with study start-up activities, ensuring the smooth and efficient transition of study protocols.ResponsibilitiesSupport the Study Start-Up Associate with tasks including tracking,...
-
Clinical Research Coordinator I
hace 4 semanas
Xico, México Icon Plc A tiempo completo**Job Summary**At ICON plc, we are committed to fostering an inclusive environment that rewards high performance and nurtures talent. We are currently seeking a highly skilled Study Start Up Associate I to join our diverse and dynamic team.Key Responsibilities:Coordinate with internal and external stakeholders to obtain necessary approvals and authorizations...
-
Senior Study Activation Lead
hace 4 semanas
Xico, México Icon Plc A tiempo completoAt ICON plc, we are a world-leading healthcare intelligence and clinical research organisation. Our mission is to advance clinical research, providing outsourced services to pharmaceutical, biotechnology, medical device, and government and public health organisations.We are seeking a Senior Study Activation Lead to lead regional clinical study start-up...
-
Study Management Associate
hace 4 días
Xico, México Thermo Fisher Scientific A tiempo completoJob SummaryWe are seeking a highly skilled Study Management Associate to join our team at Thermo Fisher Scientific. This role will provide support for remote activities on assigned projects, ensuring seamless site management and regulatory compliance.
-
Country Study Activation Specialist
hace 2 semanas
Xico, México Abbvie A tiempo completoAre you an experienced professional with a passion for clinical research and site activation?We are seeking a highly skilled Country Study Activation Specialist to join our AbbVie team in the United States.About the Role:This is an exciting opportunity to work as a site start-up expert, providing subject matter expertise (SME) support to ensure successful...
-
CRA - Clinical Research Associate
hace 4 semanas
Xico, México Icon Plc A tiempo completoAbout the RoleAs a Clinical Research Associate at ICON Plc, you will be working in a large-scale, fast-paced environment alongside a close-knit team of highly qualified CRAs.Key Responsibilities:Identify, select, initiate, and close-out investigational sites for clinical studies in phases II-IVEnsure adherence to applicable regulations and principles of...
-
Study Operations Specialist
hace 21 horas
Xico, México Pfizer A tiempo completoAbout the RoleWe are seeking a highly skilled Study Operations Specialist to join our team at Pfizer. This role is an exciting opportunity for individuals who want to work in a dynamic environment and contribute to the success of our studies.Job DescriptionAccountable for site start-up activities through activation, including qualification and deployment of...
-
Country Study Operations Manager
hace 4 semanas
Xico, México Pfizer A tiempo completoEmpowering Healthcare DecisionsPfizer's medical team is seeking a skilled professional to manage clinical studies and lead complex projects across the division. As a Country Study Operations Manager, you will be responsible for planning, directing, and communicating timelines to ensure clinical studies are completed within time, budget, and scope.Key...
-
Clinical Associate
hace 4 semanas
Xico, México Icon Plc A tiempo completoAt ICON plc, we're committed to advancing clinical research and providing outsourced services to pharmaceutical, biotechnology, medical device, and government organizations.We're seeking a Clinical Associate to join our study team and acquire clinical and corporate knowledge of clinical trial conduct.The Clinical Associate will provide administrative support...
-
Clinical Development Associate Manager
hace 2 semanas
Xico, México Fortrea A tiempo completoClinical Development Associate ManagerFortrea is a global contract research organization (CRO) dedicated to scientific rigor and clinical development experience. As a Clinical Development Associate Manager, you will contribute to the development of Central Monitoring proposal text and review of costing, contribute to proposal strategy and development when...
-
Country Approval Associate
hace 4 semanas
Xico, México Thermo Fisher Scientific A tiempo completoJob SummaryThermo Fisher Scientific is seeking a highly skilled Country Approval Associate to join our team. As a key member of our start-up team, you will be responsible for preparing, reviewing, and coordinating local EC submissions in alignment with our global submission strategy.Key ResponsibilitiesPrepares, reviews, and coordinates local EC submissions...