Senior Associate Job – Study Management – Uxbridge, London, UK

Susan Murray at CK Clinical is looking for a Senior Associate to join a global pharmaceutical company based in Uxbridge, London. This is a 12 month contract position.

The role:

As Senior Associate, your main responsibilities will include:

  • Contribute to the preparation and/or review of clinical protocols, amendments, consent forms, study guides, monitoring plans, CRFs, and subject information sheets
  • Assist in the identification of/identify clinical trial investigators. Contribute to or coordinate preparation and conduct of monitors workshops and investigator meetings
  • Work with the CRSM and CRAs to develop recruitment strategies
  • Coordinate study-level investigational product arrangements, accountability and reconciliation
  • Participate in and support study teams
  • Coordinate activities associated with site start-up and management including review of site-modified informed consent forms and tracking of the budget and contract process
  • Provide input for screening and enrolment progress
  • Provide extensive clinical site/CRA support by answering protocol-specific questions (assist in resolution of patient eligibility questions and protocol deviations)
  • Work with BSM and assay groups to coordinate shipment and analysis of clinical biological samples
  • Identify and consolidate study-related trends and report them to the clinical research manager and clinical studies team
  • Identify barriers to screening and enrolment and provide solutions
  • Support and monitor vendor activities, including relationships and training, and development of vendor specifications and scopes of work
  • Using relevant reports, identify progress of CRF data collection and query resolution. Monitor progress of studies, identify study-related trends/issues and work with the CRSM to implement corrective actions when necessary
  • Provide input to the clinical studies team for the creation of clinical study timelines and budgets
  • Assist in the processing and distribution of essential documents to the trial master file
  • Communicate regular updates to CRAs and other study staff
  • Support preparation and quality control of clinical study reports
  • Continue to increase knowledge of clinical research, clinical operations, and relevant therapeutic area

The ideal candidate:

The ideal candidate for this Senior Associate Position will have the following skills, experience and qualifications:

  • Basic Qualifications BA/BS/BSc or RN
  • Specialist experience in life sciences or medically related field
  • Previous biopharmaceutical clinical research experience (clinical research experience obtained working on industry-sponsored or industry-partnered clinical trials, or working on clinical trials at a biotech, pharmaceutical or CRO company)
  • Ability to understand technical, scientific and medical information
  • Understanding of drug development process
  • Familiar with advanced concepts of clinical research
  • Advanced computer skills
  • Experience in interactions with outside vendors, e.g., CROs and contract labs
  • Experience with administration of site budgets and grants with supervision
  • Experience with development of prospective site-selection criteria
  • Experience with reviewing adequacy of site-proposed ICs for compliance with relevant regulations
  • Detailed knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and applicable international regulatory requirements
  • Ability to write and present clearly using scientific and clinical issues terminology
  • Experience dealing with time demands, incomplete information or unexpected events
  • Good organisational and planning skills. Experience working effectively in a team/matrix environment

How to apply

For more information or to apply, please contact Susan Murray at CK Clinical on 01438 743 047 or email smurray@ckclinical.co.uk.

 

Click here to apply online now.

 

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