Reference
JM20
Type
Permanent
Location
Remote
Salary
Up to £45,000 plus Car allowance
Category
Research & Development
Sector
Pharmaceuticals / Biotechnology / FMCG

About the role

My Client are a very close team of Clinical professionals who are currently undergoing another growth spurt after the successful onboarding of new projects in the UK. As such they are looking to enhance their monitoring teams and are looking for a CRA II to join the team. This is a home based role but would be expected to attend the office for team meeting once a month.

What you will be doing

Key Areas of Responsibility 

Planning and delivery 

  • Feeding into the development of trial protocols with regard to monitoring requirements
  • Feeding into study planning and logistics with Clinical Study/Project Manager(s) with regards to study visits and scheduling
  • Writing monitoring plans in accordance with sponsor’s risk of trial

 

Specific responsibilities include: 

 

Site Selection 

  • Identifying and assessing the suitability of facilities to be used at the clinical trial site
  • Identifying/selecting investigators (where required) who will be responsible for the conduct of the trial at the trial site
  • Prepare/review all associated documents related to these activities

 

Site Set-up 

  • Setting up the trial sites, which includes ensuring each centre has the trial materials, including the trial drug/device/intervention
  • Assisting with Ethics and Regulatory submissions and ensuring applicable approvals obtained
  • Review site TMF with CTAs

 

Site Initiation/training

  • Prepare/review all associated site documents related to these activities
  • Deliver study specific related training to site including SIV meeting
  • Training site staff to trial-specific industry standards

 

Site Management/Monitoring to Close Out 

  • Liaising with Investigators and site teams on conducting the trial
  • Manage the progress of assigned projects ensuring all regulatory documents are up to date
  • Facilitate case report form (CRF) completion and submission, data query generation and resolution by site – including reviewing data collection forms to ensure in line with trial protocol; Verifying that data entered on to the CRFs is consistent with souce documents, (SDV)
  • Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required documents
  • Work with sites during the study to support and track subject recruitment to ensure targets are met
  • Monitoring the trial throughout its duration, which involves visiting the trial sites on a regular basis – as per study monitoring plan
  • Escalate study quality issues to Clinical Study/Project Manager as appropriate
  • Escalate serious breaches of the protocol and/or GCP to the Clinical Study/Project Manager
  • Ensuring all unused trial supplies are accounted for Closing down trial sites on completion of the trial
  • Archiving study documentation and correspondence

 

General Day to day responsibilities

  • Manage workload priorities ensuring the more urgent and important tasks are completed first within required timescales
  • Complete time-sheets for each project assigned.
  • Work with the Head of Clinical Operations and Clinical Study/Project Managers and support process improvements related to role and/or crossfunctional teams, including generation of controlled forms, SOPs and Guidance Documents
  • Encourage a team culture that fits within PHARMExcel work ethos creating a team environment which supports process improvement, innovation and personal accountability
  • Undertake travel as required to fulfil post (this may involve international travel)
  • Undertake any other duties commensurate with the position

 

About you

We are looking for candidates with the following experience:

  • Demonstrated experience (3years+) of monitoring multiple, multi centre Interventional clinical trials at a CRA-I level (or equivalent)
  • Previous experience in undertaking ethics and/or regulatory submissions
  • Strong organisational and time management skills
  • Excellent interpersonal skills both written and verbal
  • Ability to confidently communicate with an array of internal and external contacts.
  • Scrupulous attention to detail
  • Ability to work as part of a team and independently in an enthusiastic, proactive fashion
  • Willingness to travel as required for monitoring projects assigned (may include intrnational travel)
  • Educated to degree level or equivalent (preferably in a science related subject)
  • Experience of collecting, handling and tracking data
  • Extensive knowledge of Microsoft based packages and database applications such as Access and Excel
  • Detailed knowledge of ICH/GCP guidelines, EU Clinical Trials Directives (as amended) and FDA regulations and guidelines (as amended)
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