Clinical Research

• Independently manage all aspects of monitoring for assigned clinical trials across study phases, including site initiation, routine monitoring, and close-out visits
• Ensure compliance with protocols, GCP, ICH, SOPs, and applicable regulatory requirements
• Build strong site relationships, acting as a primary point of contact and ensuring high-quality data collection
• Identify and resolve site issues, escalating as needed to maintain trial integrity and patient safety
• Perform activities around regulatory affairs, site activation, and study startup
• Own investigator-site relationships and serve as a bridge between sponsor and site
• Travel throughout Israel

Senior Clinical Research Associate – Contractor

• Enter clinical data into electronic case report forms (eCRFs)
• Manage and resolve queries with investigator sites and project teams
• Review source documents to ensure data quality, consistency, and completeness
• Prepare for and support monitoring visits by ensuring the availability and organization of the required documentation
• Provide operational follow-up for investigator sites and contribute to the smooth execution of clinical studies
• Travel regularly throughout France to support sites, assist local teams, and ensure the quality of collected data
• Participate in coordinating clinical research activities with medical teams, investigators, and the various study stakeholders
• Ensure compliance with Good Clinical Practice (GCP) and applicable procedures throughout the study

Clinical Research Associate – Investigator Site

• Lead end-to-end performance and project management of assigned clinical trial protocols
• Manage study start-up activities, including site selection strategies, monitoring plans, and trial planning tools
• Review and contribute to patient recruitment and retention strategies
• Provide leadership, guidance, and direction to project team members across multiple locations and functions
• Evaluate project resource requirements and monitor resource utilization throughout the study lifecycle
• Address and resolve site issues, escalating risks and ensuring timely closure
• Monitor study timelines, patient recruitment, retention, and data cleaning activities
• Maintain oversight of quality standards and follow up on quality-related issues
• Drive process improvements to enhance study efficiency and operational performance
• Contribute to revenue recognition forecasting and project planning activities
• Collaborate on database lock activities and study close-out deliverables
• Ensure completion of administrative close-out procedures, study archiving, and client documentation requirements
• Manage complex oncology clinical trials for a pharmaceutical client
• Ensure compliance with ICH-GCP, local regulations, client requirements, and quality standards

Clinical Research Manager – Local Trial Manager

• Support and represent the Study Medical Manager throughout the clinical study lifecycle
• Contribute to the development and review of protocols, protocol amendments, informed consent forms (ICFs), CRFs, and medical data validation plans
• Perform medical review of patient data, listings, narratives, CIOMs, and clinical cases
• Collaborate with Clinical Operations, Pharmacovigilance, Biostatistics, and Data Management teams on data review and consistency checks
• Review study documentation and contribute to interim analyses, Clinical Study Reports (CSRs), publications, and statistical outputs
• Support preparation and management of study committees, investigator meetings, and study training activities
• Maintain medical and scientific documentation within the Trial Master File (TMF)
• Draft responses to medical questions from Health Authorities, Ethics Committees, investigators, and study teams
• Develop medical review guidelines and support outsourced medical review activities when applicable
• Contribute to audit and inspection readiness activities and support responses to findings

Clinical Scientist – Immunology

• Monitor and own the progress of clinical studies at investigative sites
• Ensure clinical studies are conducted, recorded, and reported according to protocol, SOPs, ICH-GCP, and applicable regulations and standards
• Coordinate study setup and monitoring activities
• Identify investigators
• Help prepare regulatory submissions
• Conduct pre-study and initiation visits
• Handle appropriately sized clinical trials
• Support larger clinical study teams
• Train and mentor junior staff members
• Interact directly with clients
• Initiate payments
• Participate in proposal activities, including development and client presentations
• Build the company’s network of experienced clinical research professionals for future project requirements

Senior Clinical Research Associate

• Monitor and own the progress of clinical studies at investigative sites
• Ensure clinical studies are conducted, recorded, and reported according to protocol, SOPs, ICH-GCP, and applicable regulations and standards
• Coordinate activities required to set up and monitor studies
• Identify investigators
• Help prepare regulatory submissions
• Conduct pre-study and initiation visits
• Handle appropriately sized clinical trials
• Support larger clinical study teams
• Train and mentor junior staff members
• Interact directly with clients
• Initiate payments
• Participate in proposal activities, including development and client presentations

• Monitor and own the progress of clinical studies at investigative sites
• Ensure clinical studies are conducted, recorded, and reported according to protocol, SOPs, ICH-GCP, applicable regulations, and standards
• Coordinate activities required to set up and monitor studies
• Identify investigators
• Help prepare regulatory submissions
• Conduct pre-study and initiation visits
• Handle appropriately sized clinical trials
• Support clinical study teams with larger-scope trials
• Train and mentor junior staff members
• Interact directly with clients
• Initiate payments
• Participate in proposal activities, including development and client presentations

• Monitor and own the progress of clinical studies at investigative sites
• Ensure clinical studies are conducted, recorded, and reported per protocol, SOPs, ICH-GCP, and applicable regulations and standards
• Coordinate activities required to set up and monitor studies, including identifying investigators, helping prepare regulatory submissions, and conducting pre-study and initiation visits
• Handle appropriately sized clinical trials
• Support larger clinical study teams
• Train and mentor junior staff members
• Interact directly with clients
• Initiate payments
• Participate in proposal activities, including development and client presentations

• Monitor and own the progress of clinical studies at investigative sites
• Ensure clinical studies are conducted, recorded, and reported according to protocol, SOPs, ICH-GCP, and applicable regulations and standards
• Coordinate activities required to set up and monitor studies, including identifying investigators, helping prepare regulatory submissions, and conducting pre-study and initiation visits
• Handle appropriately sized clinical trials
• Support larger clinical study teams
• Train and mentor junior staff members
• Interact directly with clients
• Initiate payments
• Participate in proposal activities, including development and client presentations

• Monitor and own the progress of clinical studies at investigative sites
• Ensure clinical studies are conducted, recorded, and reported according to protocol, SOPs, ICH-GCP, applicable regulations, and standards
• Coordinate activities required to set up and monitor studies
• Identify investigators
• Help prepare regulatory submissions
• Conduct pre-study and initiation visits
• Handle appropriately sized clinical trials
• Support clinical study teams on larger-scope trials
• Train and mentor junior staff members
• Interact directly with clients
• Initiate payments
• Participate in proposal activities, including development and client presentations