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Clinical Research Associate (CRA)

2018-10-19 17:28:352018-10-25Pop Science
Job Type Temporary / Contract
Location London
Area Central London London
Sector Clinical Research
Salary See Job Description
Start Date 07/01/2019
Job Ref BBBH683_1539970115
Job Views 727
Description


We have a great role for a Clinical Research Associate to join our client in West London. The study is just in start up and will be working in Cardiology. We can accept contractors for this year role too.

The Clinical Research Associate will identify, select, initiate and close-out appropriate investigational sites in the UK and potentially the USA too for clinical studies. The successful candidate(s) will monitor these sites in order to ensure ensuring compliance to the study protocol, Standard Operating Procedures, applicable regulations, and the principles of ICH-GCP. The CRA will also be charged with ensuring the quality and integrity of data, compliance with relevant SOPs and regulatory requirements and study completion on time and within budget.

Responsibilities Of The Clinical Research Associate

  • Monitor clinical trials to ensure absolute adherence to Good Clinical Practice in accordance with ICH-GCP standards, Declaration of Helsinki, Federal Regulatory Requirements and study procedures
  • Site management to ensure proper adherence to protocol, source data verification and assess CRF entries
  • Develop, review and edit clinical trial related documentation including but not limited to; Case Report Forms, Informed Consent Forms, study specific handbooks, guidelines and checklists
  • Assist with study protocol design, development and / or review if required
  • Complete and compile all necessary research, documentation and information to gain appropriate regulatory and ethical committee approval where required
  • Perform pre-study initiation, interim monitoring and close out visits as required
  • Carry out drug formulation administration procedures and documentation records
  • Ensure adequacy of drug shipment and drug accountability
  • Liaise with the Medical Monitor, Principal Investigator, clinical operations staff and sponsor representatives as required
  • Organise / attend investigator meetings as required
  • Provide support to the Project Manager / Country Manager with ad-hoc tasks as required


Essential Criteria

  • Bachelors degree, equivalent or higher qualification within Medicine, Biological Science, Pharmacology, Nursing or a relevant life sciences discipline
  • Clear understanding of the drug development process
  • Significant experience in performing a Clinical Research Associate role
  • Previous experience working on Cardiology studies
  • Work experience within either a Clinical Research Organisation or Pharmaceutical Company
  • Proven track record of adherence to ICH-GCP and applicable local regulatory requirements during the conduct of clinical trials
  • Ability to contribute to the development of clinical trial related documents and materials
  • Ability to independently perform pre-study initiation, interim monitoring and close out visits as required
  • Good communication skills including the ability to present complex information to both clinical and non-clinical disciplines
  • Excellent presentation skills including the ability to meet exacting standards and a keen attention to detail
  • Willingness and ability to travel


Desirable Criteria

  • Experience across a wide range of clinical indications / therapeutic areas
  • Ability and experience to work with an electronic case report form (eCRF)
  • Membership of local professional bodies or international clinical groups
  • Ability to mentor, train, supervise and inspire confidence in newcomers to the industry

Pop Science are an innovative, personal and experienced recruitment and staffing consultancy. Our aim is to make science more popular by championing careers in clinical and scientific research, technology, engineering, maths and more. Whether you want a permanent job, a contract role or even a change in perspective with some volunteering, contact us and let us help you. We support working practises that promote happiness at work.

We're an experienced, skilled team with personality; we have a passion for science, and drive and enthusiasm to make a difference to you.

Find out more at Pop Science - Recruitment

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