Job Overview:
Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.

Essential Functions:
Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
Collaborate and liaise with study team members for project execution support as appropriate.
If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.

Job Overview:
Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.

Essential Functions:
Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
Collaborate and liaise with study team members for project execution support as appropriate.
If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.

We are seeking an Experienced Clinical Research Associate (CRA).
Position Overview:
Performs and coordinates different aspects of the clinical monitoring and site management process.
Conducts remote or on-site visits to assess protocol and regulatory compliance and handles required documentation. Manages procedures and guidelines from different sponsors and/or monitoring environments (i.e. FSO, FSP, Government, etc.).
Acts as a site processes specialist, ensuring that the trial is conducted according to the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability. Ensures audit readiness.
Develops collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to role are outlined in the task matrix.

We are looking for a Clinical Trial Coord.
As a Clinical Trial Coordinator, you will provide administrative and technical support to the Project Team.
You will support audit readiness by ensuring files are reviewed on schedule detailed in the organization's WPD and department guidance document.

Job Overview:
Direct and manage the delivery of all required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs, including pre-award activities, oversight of the scope of work, budget and resources.

Essential Functions:
Oversee the execution of Site Activation (including pre-award/bid defense activities) and/or Maintenance for assigned projects in accordance with the agreed RSU site activation strategy, adhering to project timelines. Develop, implement and maintain the Management Plan according to the Scope of Work and Project Plan, within the agreed project strategy, resolving project related issues where required. Ensure collaboration across Regulatory & Site Activation, including communication with regions and countries, to successfully deliver the agreed project scope in compliance with the RSU Management Plan. Create and/or review technical and administrative documentation to support business development and enable study initiation and maintenance, as required. Provide specialist regulatory and technical scientific support to facilitate efficient business development, initiation and maintenance of clinical trials, whilst enabling compliance with regulatory requirements. Provide overall guidance and oversight of multi-regional and multi-protocol programs during initial start-up and maintenance phase as an integral member of the study management team. Determine regulatory strategy/expectations and parameters for submissions and all necessary authorizations.
Identify regulatory complexity and challenges and offer creative and practical solutions to support the bid process and subsequent execution of the site activation plan. Assess and review the regulatory landscape and contribute to the collection, interpretation, analysis and dissemination of accurate regulatory intelligence to support assigned studies and wider company, as required. Execute operational strategy/ expectations for maintenance of clinical study approvals, authorizations and review/ negotiation of contracts and essential documents. Work with Quality Management to ensure appropriate quality standards for the duration of site activation (or Maintenance, as applicable). Mentor and coach colleagues as required. Ensure accurate completion and maintenance of internal systems (with emphasis on CTMS), databases, tracking tools, timelines and project plans with project specific information. May take a lead role in developing long standing relationships with preferred our customers. Deliver presentations/training to clients, colleagues and professional bodies, as required. May be involved in activities related to monthly study budget planning and reviews.

Required Translational and Bioanalytical Research Associate
Job Description
The Translational and bioanalytical research associate will oversee the Companys translational and bioanalytical activities that are essential for drug development activities, preclinical and clinical. This typically includes bioanalytical methods development and use for pharmacokinetic and immunogenicity evaluation, as well as methods needed for pharmacodynamic exploration, such as cytokines, receptor occupancy, immunophenotyping, and a support for drug manufacturing development activities (CMC). The candidate will ensure the methods are developed, validated, and used with the highest degree of quality and compliance with international regulations.
The candidate will work with cross functional teams across the organization (preclinical biomarker/translational research, clinical development, clinical operations, CMC, regulatory, clinical data management) to ensure the successful PK and PD sample analysis for investigational drugs in our pipeline.
Be responsible for the bioanalytical methods required for our various therapeutic programs at preclinical and clinical development stage. This includes assay set-up, optimization, validation, execution, tracking of program and study timelines, review of bioanalytical protocols and reports
Propose format and strategy for pharmacokinetic and pharmacodynamic assays, immunogenicity assays such as ADA and NAb assay, flow cytometry immunophenotyping panels, Receptor occupancy assays, etc.)
Support the selection and the oversight of external advisors/Contract Research Organizations, including participating to quality assurance audits
Monitor internal and external work on bioanalytical methods
Collaborate with scientific colleagues in the R&D units from discovery to clinical teams
Maintain an up-to-date understanding of the state-of-the-Art literature, requirements, and regulatory guidelines for bioanalytical methods used in drug development
Present written and oral reports to preclinical units and management
Contribute to Project Management activities such as definition of activities, timelines, and costs/budgets
Contribute to the data analysis and summaries of results derived from pre-clinical and clinical sample analysis
Contribute to preclinical and clinical documentation definition and writing for the sections related to bioanalytical methods.

We are looking for a Senior Pathologist to join our team.
As an part-time \ in-house pathologist, you will work closely with our R&D team on new applications for our cancer diagnostics platform as we expand it to additional tissues and indications, acting as subject matter expert and advising on all clinical matters.
You will further work with our AI experts, scientific researchers and other pathologists on tasks such as:
Annotate (mark and label) various cell types and structures in whole-slide images
Analysis of algorithmic performance and clinical data
Design and execution of clinical research and case studies
Advise on improvements to our platform, workflow and user-interface
Writing clinical, scientific and other pathology-related papers
Help the commercial team engage physicians and improve adoption of our solution by customers.

We are hiring a senior data scientist to join Nucleai’s data science team. A cancer patient wants to know that their diagnosis and treatment are determined with the greatest precision and preferably using the most advanced technology. At Nucleai, we bring cancer patients cutting-edge AI-based technology by improving biopsy interpretation with machine learning and creating novel precision medicine technology. Come join our team of experienced AI engineers and world-renowned clinicians, and help us make a difference. At Nucleai, we believe that talents are our most valued asset, and as such, hiring the right people is one of our most strategic missions.
Position Overview The data science team provides the bottom line to our customers – which patients are the best fit for a cancer treatment and what is the chance of success. We do it by analyzing medical images and clinical data, researching spatial features, developing predictive models and applying statistical methods to evaluate the results. We work together with subject-matter experts, from medical doctors to software engineers, to leverage computer vision, focus on the most promising biological hypotheses and to productionize our capabilities.
Responsibilities:
* Independently lead the data science perspective in any project or assignment – from data mining, through developing new algorithms, to analyzing results and providing professional insights and guidelines.
* Contribute to the team's internal codebase with high-quality code and development standards.
* Augment our knowledge and best practices, adopt relevant SOTA data science methods and practices.
* Work closely with medical doctors, product and project managers, research scientists and software developers to focus your efforts, build new capabilities and provide value to your colleagues and our customers.