For one of our clients in Brussels, we are looking for a Senior CRA.
- Gain/maintain knowledge in protocol, monitoring manual, IMP and other relevant documents
- Check prerequisites for a trial in preparation for pre study visits, initiations etc.
- Arrange local meetings with (as applicable) PM, Clinical Project Assistant (CPA), Clinical Trial Application (CTA) officer.
- Ensures cross-functional collaboration, e.g. point of contact for medical affairs regarding investigators, as applicable.
- Company's representative for both internal and external communication.
- Support in inspections and audits.
- Identify academic networks and local treatment guidelines within the Therapeutic area in collaboration with the local ClinOps team.
- Identify and propose National coordinator, appropriate trial sites and investigators for clinical studies in collaboration with the Clinical Operations Lead.
- Provide input to the line managers of their study team members' performance relative to trial tasks.
- Prepare and present trial information at internal and external meetings e.g. local investigator meetings.
In preparation phase
- Participate in team meetings e.g. Trial Preparation Meeting, and provide information on the status of the study.
- Ensure that local adaptations to the monitoring manual are made (if needed).
- If a local vendor is needed, collaborate with the PM to identify, select and manage vendors on local level (e.g. Central laboratory, equipment,...).
- Maintain Trial Master File (TMF) up to date on OPU and site level.
- Ensure input is timely given for completeness of CTMS entries by CML or delegate.
- Check pre requisites and prepare on-site logistics e.g. complete IRT shipping forms.
- Collect essential documents for submission in collaboration with CRA, CTA officer and PM.
- Preparation of local Subject Information (SI)/Informed Consent Form (ICF) and other required trial documents for submission, TMF and Investigator Site Files (ISFs).
- Conduct and document Pre-trial contacts and supports the CML in site selection
- Arrange supplies/materials/NIMP/equipment in collaboration with the study team
- Provide site and trial information for budget and contract negotiations.
In initiation phase
- Ensure proper handover of trial to CRO-CRA
- Participates in the Trial Initiation visi at site together with the CRO-CRA and ensures that the site staff is trained in protocol and related documents and procedures.
- Ensure that all essential documents are available before initiation, maintain TMF up to date
- Ensure input is timely given for completeness of CTMS entries
In conduct phase
- Support CTA officer with adaptation of documents for substantial amendment submission.
- Adjustment of local SI/ICF and other required trial documents for submission (substantial amendment).
- Support audits and inspections on site level.
- Providing support in overview, reviewing and informing CTM of changes for budget in collaboration with the study team.
- Participates in field training and mentoring of (new) CRAs. Can provide input relative to performance review and development opportunities of (new) CRAs.
- May coordinate local CRAs team working on the same project, when applicable.
- Ensure safety and protection of trial subjects through compliance with the monitoring plan, SOPs, ICH-GCP and applicable regulations
- Collaboration with internal (e.g medical affairs, purchasing) and external (e.g vendors) to identify and evaluate issues on the project and ensure the implementation of timely solution.
- Gain/ maintain knowledge and expertise in the therapeutic areas through clinical and scientific literature review, ongoing awareness and trends of industry practices and participation in activities.
- University degree or Bachelor in medical/paramedical sciences, or equivalent through experience.
- Minimum of 3-5 years of monitoring experience.
- Flexible attitude.
- Willing to work in a start-up team.
- Knowledge of GCP guidelines & EU Directives.
- Language skills: native Dutch or French and fluent in English.
- Well organized, accurate, detailed...
- An attractive salary in line with your experience and skills.
- Fringe benefits including a company car, medical insurance, pension plan and a care plan.
- A supporting environment.
- Respect for the life-work balance.
- Career planning.
- A focus on professional and personal growth through training and coaching.
- Room for personal engagement to help shape our company's future.