For one of our clients, a leading pharmaceutical company known for its pleasant working atmosphere, we are looking for a start-up CRA to reinforce their team.
Next to your responsibilities in the start-up team, you will have a more coordinating role as link between the local study teams and the Project Managers.
Ready for a next step in your career? Don't hesitate to apply!
The Study Start-up (SSU) Specialist functions as a subject matter expert on all SSU-related activities in the country/region, oversees and leads SSU activities in collaboration with other clinical research stakeholders and serves as a leader for local/global SSU process improvements and patient recruitment strategies.
Study Start-up Coordination and Execution:
• Coordinate guide and assist with all start up activities prior to site activation, including but not limited to:
- Site Informed Consent Form (ICF) localization and guidance in line with regulatory/health authority requirements
- Ethics Committee information, meeting dates & costs
- Ethics applications & associated online systems
- Ethics & Governance submission processes
- Clinical Trial Health Authority application and regulatory submission process
- Contracts & Indemnity request process
- For global studies, localize global Informed Consent Form (ICF) with country requirements
• Maintain up to date knowledge, ensure adherence and compliance with local regulatory requirements and associated documentation.
• Review, analyze and collate metrics to ensure processes are in place that drive efficiency and reduction of timelines across start up and contracts negotiation.
• Ensure all start up information & requirements are kept up to date in a central repository for both global and local Study teams.
• Assist with label preparation and approval (local label representative) for studies in collaboration with local regulatory department.
• Track metrics and study start-up timelines to identify trends and opportunities for improvement.
• Liaise and collaborate with relevant authorities / bodies to further enhance clinical trial processes, government policies / laws, via innovative approaches.
• Maintain currency and awareness of changes in Start Up processes across government, hospital & industry & liaise with stakeholders to resolve any SSU issues.
• Proactively respond to information survey requests by government / industry bodies.
• Provide continuous and proactive communication with ECs / hospital administration / industry bodies to obtain accurate and up to date information on clinical trial status and activities.
• Maintain communication with local legal/regulatory/medical affairs departments to ensure input is sought and all internal/external requirements are met.
• Provide guidance to CSMs and CSS on regulatory/ethics, track & drive site activations by regular review and monitoring status of submissions/activations.
• In collaboration with vendor management and procurement, provide input as required into vendor identification, selection, and RFI/RFP process.
• Liaise and share best practices with other SSUS within the region/organization.
New Site Identification:
• Assist with identification and tracking of new sites in collaboration with CSMs.
• Provide expertise and guidance to Global and/or Local Study Teams for identification, creation and implementation of specific recruitment/retention tactics & contingency planning.
• Initiate patient recruitment meetings with CSM and advise on study-specific recruitment & retention needs.
• Develop innovative patient recruitment/retention practices and share concepts with vendors as needed.
• Provide justification/recommendation of site closure in collaboration with CSM.
• Provide reports to study teams on overall site performance as required.
• Negotiate contracts and study budgets with sites during the study start-up phase to ensure finalization.
• Provide local fee structures and budgetary advice as required and ensure compliance to Fair Market Value (FMV) in the country.
• Collaborate with CSMs to maintain data to ensure FMV.
• Liaise with management / CSMs to implement budget cost containment and implement contingencies as required.
• University Degree or Equivalent preferably in a medical/science-related field
• Prior work experience demonstrating knowledge and understanding of clinical trials, such as that obtained in a clinical trial monitor capacity (CRA), and experience managing projects
• Demonstrated knowledge and understanding of ICH-GCP/GPP, the regulatory, ethics and contractual requirements for starting clinical trials in relevant country
• Demonstrated competence in analysis, planning and problem solving
• Excellent communications skills including the ability to state opinions clearly, ask questions, seek clarification, communicate facts objectively, challenge when appropriate, and pursue issues to resolution
• Ability to present clear messages from complex information/data to all levels in the organization in both written and spoken English, French and Dutch
• Experience working as part of a team with a proven ability to make an active contribution to the team’s performance and teamwork
• Able to make effective decisions, self-motivated, assertive, and displays initiative
• Proven project management and organizational skills and the ability to prioritize and manage multiple tasks with flexibility
• Demonstrated computer literacy, usage of MS Office software, web-based systems and databases
Availability to travel domestically and internationally if required.
015 21 11 04