As a leading global contract research organization (cro) with a passion for scientific rigor and decades of clinical development experience, fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. with over 19,000 staff conducting operations in more than 90 countries, fortrea is transforming drug and device development for partners and patients across the globe. as a leading global contract research organization (cro) with a passion for scientific rigor and decades of clinical development experience, fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. with over 19,000 staff conducting operations in more than 90 countries, fortrea is transforming drug and device development for partners and patients across the globe. we are seeking an experienced and highly motivated senior centralized study specialist to join our team. this role involves managing clinical systems, supporting study documentation, ensuring compliance, and providing leadership and mentorship to junior team members. the successful candidate will play a pivotal role in the successful execution of clinical trials and contribute to process improvement initiatives. key responsibilities: clinical systems management: manage clinical systems, including ctms milestone updates at site/country/protocol levels.manage and review study documents and...
Tasks 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 which may jeopardize the clinical trial delivery or patient safety from the task assigned. skills st...
As a leading global contract research organization (cro) with a passion for scientific rigor and decades of clinical development experience, fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. with over 19,000 staff conducting operations in more than 90 countries, fortrea is transforming drug and device development for partners and patients across the globe. as a leading global contract research organization (cro) with a passion for scientific rigor and decades of clinical development experience, fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. with over 19,000 staff conducting operations in more than 90 countries, fortrea is transforming drug and device development for partners and patients across the globe. we are seeking a dedicated sr centralized study associate to join our team. the successful candidate will be responsible for: clinical systems & access management: managing clinical systems and access.maintaining study databases (ctms, iwrs, edc, etc.).supporting the study team in data review and other related activities.tracking and following up with cras for outstanding issues.generating study-specific reports.managing internal/external communications.assisting in ensuring training compliance for study teams.managing study payments (site and vendor). data review: following up with cras...
As a leading global contract research organization (cro) with a passion for scientific rigor and decades of clinical development experience, fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. with over 19,000 staff conducting operations in more than 90 countries, fortrea is transforming drug and device development for partners and patients across the globe. as a leading global contract research organization (cro) with a passion for scientific rigor and decades of clinical development experience, fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. with over 19,000 staff conducting operations in more than 90 countries, fortrea is transforming drug and device development for partners and patients across the globe. we are seeking an experienced and highly motivated centralized study specialist i to join our team. this role involves managing clinical systems, supporting study documentation, ensuring compliance, and providing leadership and mentorship to junior team members. the successful candidate will play a pivotal role in the successful execution of clinical trials and contribute to process improvement initiatives. key responsibilities: clinical systems management: oversee and manage clinical systems.maintain study databases (ctms, iwrs, edc, etc.).support etmf management. study coordination: tr...
Summary of responsibilities site management responsibility for clinical studies according to fortrea’s standard operating procedures, ich gcp guidelines, applicable project plans and sponsor requirements, including verification of study training records. conducts site monitoring responsibilities for clinical trials according to fortrea’s standard operating procedures (sops), ich guidelines and gcp; including pre-study, site initiation, process monitoring, routine monitoring, and close-out visits. prepares and implements project plans related to clinical monitoring responsibilities. ensures the protection of subjects by verifying that informed consent procedures and protocol requirements are adhered to alongside applicable regulatory requirements. safeguards data integrity by careful source document review, source document verification, query generation, and resolution against established data review guidelines on fortrea or client data management systems. confirms site regulatory documents and applicable etmf/sponsor documents are complete and current throughout the duration of the trial. guarantees that the study investigational product inventory and accountability is accurate and that study materials are stored securely and per protocol requirements. ensures adherence to global quality control and cra performance metrics. ensures audit readiness at site level. acts in the project role of a lead cra as assigned. general on-site monitoring responsibilities: ensure the study staff who will conduct the protocol have received the proper materials and instructions to saf...
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