Lead CRA - Madrid

Highly Competitive
  1. Permanent
  2. Clinical Research Associate (CRA)
  3. Spain
Madrid, Spain
Posting date: 27 Jan 2021

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.

Job Responsibilities

  • 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.

To Apply

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