Clinical Scientist

Summary

Join Precision for Medicine as a Clinical Scientist and work remotely from Poland, Hungary, Serbia, Romania, or Slovakia. You will perform early and continuing scientific review of clinical data, ensuring data quality and consistency. Responsibilities include collaborating with project teams, developing documentation, supporting data output development, and assisting with quality risk identification. You will also provide training, conduct UAT, and contribute to data cleaning processes. This role requires a Bachelor's degree in a science or healthcare discipline, at least two years of relevant experience, and oncology therapeutic experience. Proficiency in medical terminology, EDC systems, and data visualization tools is essential.

Requirements

• Have a Bachelor’s degree or equivalent combination of education/experience in science or healthcare discipline with proficiency in medical terminology
• Have at least two (2) years in clinical operations and/or, data management or related discipline in either the CRO or pharmaceutical industry and/or experience conducting oncology clinical research as a Study Coordinator, Research Nurse or related discipline, or equivalent, relevant experience and/or demonstrated competencies
• Have oncology therapeutic experience with ability to apply working knowledge (e.g., understanding of clinical and oncology standards of care and associated side effects, biomarkers, etc.)
• Have experience in the review of data from oncology clinical trials with working knowledge of oncology standards
• Have computer proficiency
• Have working knowledge of FDA & ICH/GCP regulations and guidelines

Responsibilities

• Serve on assigned project team(s) reviewing subject data for accuracy per protocol, associated references and oncology standards of care and principles to support overall data quality and consistency (clinical sense of the data)
• Develop and maintain a good working relationship with internal and external project team members, serving as an ambassador to promote Precision’s high quality and ethical image in accordance with the company Core Values
• Collaborate with and be supported by CSAI-OS management as well as the Medical Monitors to support cross functional departmental communication as applicable on data capture / review trends (e.g., Medical Monitoring, Safety, Clinical Operations, Project Management, Data Management, SAS Programming, Biostatistics, Translational Science, other vendors, etc.) to meet project deliverables in compliance with GCP/ICH, the protocol, oncology standards and applicable Project Plans and SOPs
• Provide input into project related documentation such as EDC specifications and related completion guidelines, CSAI-Data Review Guidelines, etc. and require patient review to be coordinated and tracked with other departments as applicable (data management, medical, safety etc.)
• Support the development and User Acceptance Testing (UAT) of data outputs with CSAI-OS Programming (e.g., Smart Patient Profiles, CSAI-OS metrics/trackers, CSAI-OS listings)
• Require the use of various EDC systems and data visualization tools
• Assist CSAI-OS Management by serving as a resource for project teams regarding scientific, clinical, oncology related questions supported by Medical Monitoring
• Provide routine status updates on findings and escalate issues as appropriate with project team and CSAI-OS Management
• Assist with identification of quality risks and issues and recommend corrective action plans as needed to address deficiencies in performance throughout the life of the project
• Conduct UAT of CSAI-OS programming output and participate in EDC UAT supporting the CSAI-OS functionality as applicable
• Assist CSAI-OS Management to provide review of the protocol from a scientific-operational perspective
• May provide indication input into data capture and other clinical trial document development (e.g., EDC specifications, completion guidelines, edit checks, review guidelines, etc.)
• Assist in the development and implementation of strategy for an integrated data cleaning process between all applicable departments (e.g., data management, medical, safety, vendors, sponsor, etc.)
• Review and analyze clinical trial data sources early and ongoing throughout the trial to ensure consistency, integrity and accuracy based on CSAI-OS project specific review guidelines with an emphasis on scientific and clinical sense (e.g., adherence to applicable disease assessment criteria)
• Issue and resolve queries in various EDC systems
• Communicate effectively with the internal and external project team as applicable and CSAI-OS management to relay data quality issues/findings and implement necessary actions in response to those issues (e.g., CRA and/or site re-training)
• Provide study-specific CSAI-OS training for project teams to ensure accurate and consistent collection including re-training as applicable based on review findings
• Develop applicable study-specific monitoring/CRA and data review tools as applicable
• Participate as applicable in internal and external study-specific team meetings
• Serve as a resource to the project team for scientific questions regarding data capture
• May review dictionary coding
• Establish CSAI-OS task tracking metrics to monitor trial and team progress towards project goals
• Provide routine Project Management updates at macro and micro level
• Ensure applicable eTMF documentation related to CSAI-OS is provided and managed including version control of CSAI-OS owned documents
• Perform other duties as assigned by management

Preferred Qualifications

• Have a Medical related degree, RN, OCN, RPH, PharmD, etc
• Have experience as a Clinical Research Associate (CRA) or Study Coordinator/Research Nurse
• Have experience in phase I, II and III oncological trials
• Have experience with electronic data capture systems (EDC) and data visualization tools