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Lead CRA - Madrid

Employer
Proclinical Staffing
Location
Madrid, Spain
Salary
Negotiable
Start date
27 Jan 2021
Closing date
10 Feb 2021

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Job Details

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

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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Company

At ProClinical we have one aim: to support life science companies in the many challenges they face while combatting unmet medical need worldwide.

Ageing populations, rare diseases, epidemics and the millions of patients without access to medication are just a few of the pressing issues that life science companies contend with. The industry is under increasing pressure to develop new and innovative ways to save and improve patients’ lives. 

ProClinical’s mission is to support their work by connecting life science companies with the highly skilled professionals they need to continue innovating. 

Internal recruitment and HR teams often struggle to continuously source skilled, experienced professionals to fill highly-specialised and niche roles. ProClinical combines a deep understanding of the industry with extensive candidate networks to provide both a technical and cultural fit for our life science partners.

 

Company info
Website
Telephone
0800 988 4437
Location
Eldon House
Eldon Street
London
EC2M 7LS
United Kingdom

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