"Do you have a recent Site Management / Monitoring experience as CRA (at least 5 years) with the desire to take the next step in your career as a Lead CRA? Are you fluent in ENG, NL and FR and ready to work in Brussels? Then we've got your dream job! "
The Lead CRA will be the main point of contact for investigative sites as well as accountable for safeguarding the quality and patient safety at the investigator site. The consultant is responsible for site monitoring and oversight and building and retaining relationships from site activation through the lifecycle of studies.
- Responsible for relationship building and management
- Responsible for proactively providing local intelligence
- Accountable for study start-up, activation, and execution to plan for targeted sites
For all sites:
- Provide enrollment support and ensure progress by responding to start up and recruitment issues from investigators, partner with study team to define and support recruitment initiatives at site / country level.
- Maintain a thorough knowledge of assigned protocols.
- Proactively identify, manage and escalate site issues related to study delivery, triaging and coordinating communications and resolution efforts by the colleagues.
Responsible for CRO and Study Management Interface:
- Support local CRO representatives develop positive Investigator relationships throughout the life of the study and escalate any training or compliance concerns with Site Excellence Partner and Study Management.
Responsible for process, standards, and oversight:
- Responsible for site and monitoring quality, regulatory and GCP compliance.
- Work with CRO CRAs, and other CRO colleagues as appropriate, to drive resolution of oversight issues.
- Identify potential improvements for the processes.
- Review of monitoring visit reports.
Protocol Site Oversight:
- Maintain a thorough knowledge and understanding of assigned protocols, including associated risks and mitigations, as it relates to site and monitoring quality.
- Attend Investigator meeting/protocol training to ensure clear understanding of the protocol requirements.
- Seek assignment to complex protocols driven by demonstrated capability in role.
Site and Study Management Interface :
- Support local Investigator relationship management with the Site Relationship Partner.
- Serve as point of contact for quality and safety escalations for CRO, CRAs, Site Relationship Partner and Study Team.
- Support vendor relationship management at country-level.
Training and Education:
- BS/BSc/MS/MSc or equivalent + 7 years of clinical research experience and/or quality management experience.
- English is required.
- Experience implementing centrally designed and developed initiatives on a local basis
- Solid knowledge of clinical development processes with strong emphasis on monitoring
- Demonstrated ability to oversee a 3rd party and/or demonstrated ability in Quality Assurance (preferred)
- Site Management/Monitoring (CRA) experience (preferred)
- Project management experience preferred in the clinical development area
- Ability to lead, troubleshoot and influence for delivery
- Independent approach
- Demonstrated knowledge of quality and regulatory requirements for applicable countries
- Demonstrated knowledge of site intelligence at country/cluster level in support of site recommendation
- Demonstrated knowledge of clinical trial methodology and the drug development process, related to monitoring clinical trials, GCP, FDA, or country-specific regulatory environment
- Demonstrated experience in site activation
- Demonstrated ability to manage projects and cross-functional processes
- Availability to travel regularly within country and region is required.
- Operational report to Directors of Clinical Operations
- Indirect relationship with Study Management Group Lead and Targeted Investigator Network Strategy Implementation Lead
- Coordinates with institutions and investigators at the local level
- Coordinates with CRO at country/site level
- A balanced salary package based on your capabilities and experience, including meal vouchers.
Existing right to work in Europe required ( please read job spec in full before applying ).
Vacancy Number: 17674