Clinical Research Professional
As the Clinical Research Professional (CRP) at radiomics, you will be monitoring clinical trials of Radiomics.
Clinical research Professional
We are currently looking to enlarge our team with a Clinical Research Professional
The main function of the clinical research professional is to monitor clinical trials of Radiomics. The CRP will work directly with the medical centers involved in the trials, with the contract research organizations (CRO), and with any other relevant subcontractors. The CRP will ensure compliance with the clinical trial protocols, checks clinical site activities, reviews case report forms (CRFs), and communicates with clinical research coordinators. S/he will function as a gatekeeper of all information collected in any clinical trial, either internal or external. The CRP will be also involved in other activities of the Medical Department, related to the clinical trials.
- Oversees the development of clinical trial protocols; participates in the development of the overall clinical plan, drafts protocols, collaborates on statistical analysis plans, and coordinates the protocol review and approval process, to include submissions to regulatory agencies.
- Participates in the identification of potential investigators and clinical sites, both nationally and internationally; conducts pre-study site visits, collects and reviews data, and prepares evaluative reports; participates in the final selection of investigators and study sites.
- Assists in the identification of contract research organizations and centralized services such as clinical laboratories; assesses qualifications and experience in relation to proposed research activities, and participates in final selection.
- Assists with the development and implementation of study-specific monitoring and reporting procedures, methods, guidelines, and tools; participates in the establishment of baseline parameters and edit check specifications, and in the development of subject tracking systems.
- Conducts clinical trial site initiation visits for imaging data, participates and/or conducts site meetings and multicenter investigator meetings and prepares reports.
- Conducts site follow-ups to identify significant problems and issues and to ensure that all clinical aspects of studies are being carried out in accordance with the local and international regulations, guidelines and policies.
- Reviews files and records, case report forms, and source documents for completeness, accuracy, consistency, and compliance; identifies deficiencies and discrepancies, and provides remedial training and/or initiates corrective action as required.
- Ensures appropriate transmission of clinical case data to the data management centers; reviews case report queries and problems, and clarifies and/or obtains changes to data as appropriate.
- Creates accurate databases of imaging and non-imaging data for single and multi-center studies.
- Assists in the termination of clinical studies by identifying items and issues for review and/or follow-up; assembles necessary documents, review of completeness and accuracy of files, and retrieval of relevant codes and documents; prepares study termination reports.
- Interacts with the relevant stakeholders, both external and internal, in particular with Technology and R&D teams.
Your educational background and competences:
- Master Degree in Life Science, Biomedical Science, Nursing or equivalent or similar, obtained by experience
- 3 year of professional experience in equivalent position is an asset, but not an exclusion criteria
- Knowledge of ICH-GCP guidelines is an asset
- Good understanding of biology and biological process
- Basic knowledge of medical imaging modalities
- Knowledge of Oncology and Respiratory Medicine fields is an asset
- Basic understanding of statistical analysis and modelling
- Proficiency with MS Office applications
- Ability to effectively communicate in English. French is an asset.
Your desired characteristics:
- Strong interest and some knowledge of drug/devices development, digital healthcare, information systems, networking and ICT
- Hands-on mentality, you work accurately, and you fit into an innovative environment
- Ambitious, fast learner, passionate, curious and creative
- Willing to have a strong impact on cancer treatment by helping pharma companies and clinical professionals embrace new biomarkers in their drug development and decision making
- Ability to energize, develop, and build rapport at all levels within an organization
- Strong written and verbal communication and clear-thinking skills with the ability to synthesize complex issues into simple messages
- Be pro-active and take initiatives
- Ability to multi-task in a very fast-paced environment
- Solutions oriented and pragmatic
- Robust interpersonal skills, with demonstrated ability to work independently as well as effectively collaborate with peers.
What we offer you:
- Unique opportunity to help shape a high potential start-up active in a leading-edge AI medical field
- A challenging and diversified position within a high-potential innovative start-up company.
- Huge and fast personal growth potential for the successful candidate
- A young, dynamic, and multicultural environment
- Onboarding, training, and mentorship
- Empowerment, accountability, and recognition
- An attractive salary package, with bonus schemes, in line with the position responsibilities and your experience
Up to the challenge?
If you feel challenged by this opportunity and have a team-oriented / self-driven learner mentality, please send your CV and cover letter to [email protected]
We look forward to welcoming you into this fast-growing Radiomics team!
Founded in 2016, Radiomics is a next generation Liege-based imaging CRO built upon the unparallel experience of its founders, pioneers of the radiomics science. Radiomics uses its proprietary advanced image analysis technology based on AI, deep learning and federated learning to unravel the gold mine of hidden data information embedded in standard medical images with the aim to support insight-based decision making for optimizing pharmaceutical and biotech companies’ clinical trials and drug development studies and for providing clinicians with a patient-centered approach based on personalized medicine.
Based on its non-invasive approach, Radiomics has developed and validated a full pipeline of software as medical device, aimed at disease detection, patient follow-up and treatment prediction. Radiomics first product platform, RadiomiX Toolbox, allows to mine quantitative image features from (standard-of-care) medical imaging. Among other ongoing projects, in 2021 Radiomics will start its first clinical trial, SALMON, aiming at proving the power of radiomics for clinical decision making on oncology compared to current standard-of-care. In addition, Radiomics owns a strong intellectual property portfolio, including rights on the radiomics trademark, and its team is continuously working on new solutions, in collaboration with multiple national and international partners and is currently closing partnerships to scale up its activities geographically and into other disease areas.
Radiomics is ISO 13485 compliant and aims to be ISO 13485: 2016 certified in 2021.