Lead CRA - Madrid
An opportunity has arisen for a Clinical Research Associate Lead, to work under the project manager to ensure the progression of the clinical research project.
- Lead a project team of Clinical Research Associate (CRA) and provide project team members with trial, project, logistics, technical and administrative level support
- Support the Country Project Manager following CRA freelance in all the delegated activities
- Is responsible for the management of all operational aspects of the assigned studies
- Provide guidance for all monitoring activities as required and act as contact point for all CRA questions on practical aspects of study conduct
- Oversee performance of the site CRA and site activities in accordance with the Monitoring Plan, Protocol, Good Clinical Practice (GCP), ICH guidelines and applicable local and international regulation
- Provide or arrange ongoing training to CRAs as new information becomes available during trial
- Put together initiation presentation and package for CRAs to use during site initiation visits
- Ensure study initiations planned and actioned by the CRAs as soon as possible after approval obtained
- May accompany monitors on site visits to provide training and assistance and ensure that protocol requirements are being correctly interpreted and followed
- Establish Local Recruitment Plan and ensure timely patient recruitment to committed study targets
- Review regularly study progress against project plan/recruitment plan
- Review all reports produced by the site CRA for the assigned projects
- Plan and work with the site CRAs to distribute amended documents to sites, follow through to ensure approvals obtained and actioned appropriately at all sites
- Review country paper and e-TMFs ongoing and prior to archiving
- Check that the CRAs complete site paper and e-TMFs review ongoing and prior to archiving
- Support the Country Project Manager in the local project management activities
- Support the Country Project Manager in the regulatory submission, even revising the complete package of the submission and contract site negotiation
- Enter all the information required in the TRACK system on an ongoing basis
- Moreover, the Lead Clinical Research Associate can be allocated on sites undertaking site management responsibilities and conducting all type of visits, as necessary.
Skills and Requirements
- Bachelor or Master's degree in life sciences, pharmacy or nursing.
- Preferably a minimum of 4 years of clinical research experience in the Pharmaceutical/CRO industry (including site initiation, monitoring and site closure).
- Experience of Clinical Trial Project Management.
- Strong knowledge of GCP/ICH Guidelines and other applicable regulatory requirements.
- Experience of training and educating junior CRAs.
- Strong knowledge of ICH Guidelines and other applicable regulatory requirements (including GCP refreshment course every other year).
- Be aware of the commercial value of the performance.
- Be accurate and have a high level of quality conscious.
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