Core ICF Developer

Há 4 dias

São Paulo, Brasil Fortrea Tempo inteiro

Responsibilities Responsible for developing, reviewing, finalizing and maintaining clinical trial documents such as informed consent forms. Applies knowledge of GCP Guidelines regulatory requirements regulatory framework of privacy standards and biological samples standards therapeutic area(s) and Investigational Medicinal Products (IMPs) to review and develop Informed Consent Forms (ICF). Ensures that the content of the Master Informed Consent Form is consistent with the corresponding protocol and fully informs the subject of all information about the research study that a potential research subject will need to know to decide if they want to enroll in the study. Ensures that research participants can easily understand the content and the scientific and medical language of the consent form. Ensures that documents are written / edited in compliance with the global industry standards. Ensures client‑specific guidance and requirements are included within the Master Informed consent form during development and review. Supports the development, review, and approval of master templates to ensure effective and timely execution of protocol/site activation. Create review and revise training material and plans to support the training requirements of the team. Responsible for timely and appropriate communication to all stakeholders as applicable. Liaise with PM / Designee to communicate any trends, outstanding issues, safety concerns or any other activity or lack thereof that may jeopardize the clinical trial delivery or patient safety from the task assigned. Skills Strong knowledge of the drug development process. Good understanding of FDA IND / NDA requirements. Strong understanding of regulations, policies and procedures concerning the conduct of clinical trials including FDA regulations, biological samples regulations, GDPR, and GCP guidelines. Knowledge and understanding of medical terminology and health literacy principles are a plus. Excellent customer service/management skills. Computer skills with excellent proficiency in MS Word. Excellent command of the English language along with written and verbal communication skills. Ability to influence stakeholders through insight into industry trends. Demonstrated ability to plan, prioritize and deliver timely. Demonstrated ability to pay attention to detail. Ability to deliver consistently high‑quality work. Ability to negotiate with others. Ability to mentor and train others. Ability to adapt to this fast‑paced dynamic environment. Requirements University / College Degree (medical degree preferred) Previous experience in writing and editing master informed consent forms and other clinical trial-related documents (5 years or more). Advanced English (Oral and Written) Strong working knowledge of the ICH‑GCP guidelines and all other applicable guidelines and regulations. In addition to the above, candidates without medical/life sciences background but with relevant domain knowledge and experience may be considered if deemed appropriate for specific tasks and activities. Learn more about our EEO & Accommodations request here . Employment Type: Full‑Time Experience: years Vacancy: 1 #J-18808-Ljbffr

  • Developer (Core Banking)

    2 semanas atrás

    Sao Paulo, Brasil Equação IT Tempo inteiro

    Equação IT is a company focused on boosting technology and solid solutions through our expert consultants leading a high perspective and adding value to our customers with the purpose of providing optimization and business growth to our partners. We are looking for a Developer (Core Banking) with the following requirements: **Requirements**: - Developer...

  • NET Core Developer

    2 semanas atrás

    São Paulo, Brasil INDI Staffing Services Tempo inteiro

    At INDI, we're passionate about empowering individuals and businesses worldwide. Our cutting-edge recruiters connect leading companies with top talent, fostering a dynamic environment where innovation thrives. Join us in shaping the future of work. Overview of the role: Being a .NET Core Developer in our Development Team is just like being a full-time...

  • NET Core Developer

    2 semanas atrás

    São Paulo, Brasil INDI Staffing Services Tempo inteiro

    At INDI, we're passionate about empowering individuals and businesses worldwide. Our cutting-edge recruiters connect leading companies with top talent, fostering a dynamic environment where innovation thrives. Join us in shaping the future of work. Overview of the role: Being a .NET Core Developer in our Development Team is just like being a full-time...

  • .Net Core Developer

    4 semanas atrás

    São Paulo, Brasil INDI Staffing Services Tempo inteiro

    At INDI, we're passionate about empowering individuals and businesses worldwide. Our cutting-edge recruiters connect leading companies with top talent, fostering a dynamic environment where innovation thrives. Join us in shaping the future of work.Overview of the role:Being a .NET Core Developer in our Development Team is just like being a full-time problem...

  • Senior Frontend Developer

    Há 7 dias

    Sao Paulo, Brasil e-Core Tempo inteiro

    **About e-Core**: We are a technology services partner for digital innovation and business transformation. We combine our global experience in key industries and the latest technologies to help fast-growing and established companies transform and accelerate their business models, develop innovative digital solutions, scale technology capabilities, and...

  • .NET Core Developer

    Há 3 dias

    São Paulo, Brasil BairesDev Tempo inteiro

    .NET Core Developer - Remote Work | REF# Join to apply for the .NET Core Developer - Remote Work | REF# role at BairesDev .NET Core Developer - Remote Work | REF# Join to apply for the .NET Core Developer - Remote Work | REF# role at BairesDev Get AI-powered advice on this job and more exclusive features. At BairesDev, we've been leading the way in...

  • .net core developer

    3 semanas atrás

    São Paulo, Brasil INDI Staffing Services Tempo inteiro

    At INDI, we're passionate about empowering individuals and businesses worldwide. Our cutting-edge recruiters connect leading companies with top talent, fostering a dynamic environment where innovation thrives. Join us in shaping the future of work.Overview of the role:Being a. NET Core Developer in our Development Team is just like being a full-time problem...

  • .NET Core Developer

    2 semanas atrás

    São Paulo, Brasil INDI Staffing Services Tempo inteiro

    At INDI, we’re passionate about empowering individuals and businesses worldwide. Our cutting‑edge recruiters connect leading companies with top talent, fostering a dynamic environment where innovation thrives. Join us in shaping the future of work. Overview of the role: Being a .NET Core Developer in our Development Team is just like being a full‑time...

  • Core ICF Developer

    Há 4 dias

    São Paulo, Brasil Fortrea Tempo inteiro

    ResponsibilitiesResponsible for developing, reviewing, finalizing and maintaining clinical trial documents such as informed consent forms. Applies knowledge of GCP Guidelines regulatory requirements regulatory framework of privacy standards and biological samples standards therapeutic area(s) and Investigational Medicinal Products (IMPs) to review and...

  • .NET Core Developer

    4 semanas atrás

    São Paulo, Brasil INDI Staffing Services Tempo inteiro

    At INDI, we're passionate about empowering individuals and businesses worldwide. Our cutting-edge recruiters connect leading companies with top talent, fostering a dynamic environment where innovation thrives. Join us in shaping the future of work. Overview of the role: Being a .NET Core Developer in our Development Team is just like being a full-time...