St-Kwintens-Lennik, Flemish Region, Belgium
Passionate about clinical research 🔬, pain management, prevention and health promotion, technological and digital innovations in health care. Currently working as a Senior Clinical Research Associate CFSP in Belgium for the American multinational CRO IQVIA. IQVIA is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. For recruiters: I am not interested in an other CRA role, but on the lookout for Clinical Trial Management(CTM)/Clinical Project Management(CPM) roles.
- Performing site initiation, monitoring and closeout visits, - Maintaining appropriate documentation, - Establishing communication with PI, PI department and pharmacy, - Administering protocol and related study training to assigned sites, - Evaluation the quality and integrity of site practices, - Escalating quality issues if appropriate, - Managing study and site progress by tracking regulatory submissions, recruitment, case report form (CRF) completion and data query resolution.
Key responsibilities: Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice. Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas. 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 to Clinical Project Manager (CPM), Clinical Lead (CL) and/or line manager. 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. 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. Working/ worked on studies with following indications (phase 2, 3/3b and 4): - COVID-19 - Prostate Cancer - Advanced Melanoma - Alzheimer Disease - FGFR abberations - Systematic Lupus Erythematosus - Spinal Muscular Atrophy
Key responsibilities: Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice. Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas. 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 to Clinical Project Manager (CPM), Clinical Lead (CL) and/or line manager. 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. 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. Working/ worked on studies with following indications (phase 2, 3/3b and 4): - COVID-19 - Prostate Cancer - Advanced Melanoma - Alzheimer Disease - FGFR abberations - Systematic Lupus Erythematosus - Spinal Muscular Atrophy
Pain in Motion is an international research consortium that focuses on pain and body movement - Setting up, coordinating & conducting clinical research, pain research, chronic pain, pain management, pain education, physiotherapy, physiotherapy lecturing/teaching, public speaking, giving workshops, analyzing data and data management.
Neurorehabilitation, Robot-assisted gait training and Virtual reality During this period I worked on two projects in the field of neurorehabilitation: - The MIRAD (an integrated Methodology to bring Intelligent Robotic Assistive Devices to the user) project. -Engagement of neurological patients during robot-assisted gait rehabilitation using virtual reality. During this period, I wrote a grant application for further funding via FWO: FWO call 15 June 2016; Strategic Basic Research (SB)-proposal: Virtual reality during robot-assisted walking in stroke patients: The influence of a head-mounted virtual reality intervention, different virtual environments and functional feedback on patient engagement. Analyzing data and data management
Scientifically designed cTreatments guide the natural recovery capacity of the human body, using computer controlled thermodynamic energy exchange protocols to improve surgery, injury and trauma outcome. Job requirements and competences: Presenting Technology & Treatments to distributors. KOL, doctors, medical team of sport teams, ... Training of medical staff starting using Technology Support to Medical Director, Sales manager and Quality Manager Setting up communication platform about the Technology and Treatments Design and functionality of Server, Treatments. Pads and all additional applications Developing Treatments in accordance with the Treatment strategy and protocols framed by the Medical Director Processing scientific literature Responsible for the Zotero library Collecting experimental and clinical data with experimental studies with the aim to validate treatment protocols (in close collaboration with the Medical director) Supporting and follow up of clinical studies and Treatment reference centers (in close collaboration with the Medical director & the Operational Manager) Editing articles, case reports, power point presentations. Treatment training, ... as support to sales, KOL (key opinion leaders), training, ... Assist in the writing and implementation of medical trials, determining strategy & relevant subjects for medical trials and research Document all Adverse Events and report materiovigilance Develop effective relationships with key influencers and external organizations Answer medical questions of clients. concerning protocols and products Support in congress strategy, concepts & booth
- Assessment and treatment - Patients with neurological and acute/chronic musculoskeletal disorders