+44 208 985 0565

Clinical Trial Monitor

2020-07-23 15:42:472020-08-19 Pop Science
Job Type Permanent Full Time
Location Greater London
Area Central London Greater London
Sector Science
Salary £35k - 45k per year
Start Date ASAP
Job Ref 926
Job Views 677

***New Role***Clinical Trial Monitor required***3 - 4 Month Contract - White City***

The person would be performing clinical trial monitoring activities of an industry-sponsored, multi-centre, cardiovascular observational study in the UK and Ireland. They will be required to contact and follow-up with investigator sites with CDAs and site feasibility evaluation, arranging local information packs, perform site contract and budget negotiation.

Key Responsibilities

  • To ensure that the studies are conducted in compliance with protocol, overall objectives, FDA/ICH GCP and the ICTU SOPs and are run according to agreed timelines
  • To train the staff from the investigator sites in the conduct of the study, documentation, record keeping and regulations
  • To maintain central records for the investigator sites including maintenance of the Trial Master Files (TMFs) and creation, distribution and maintenance of the Investigator Site Files (ISFs)
  • To attend regular internal team meetings with the study team and external meetings with the sponsor/CRO
  • To set up and attend regular meetings with study staff, through a combination of meetings in person and via teleconference, with staff at the co-ordinating centres, and to facilitate communication between them
  • To assist with compliance with ICH-GCP and local regulations at all research sites
  • To conduct regular monitoring visits to participating sites in accordance with the study monitoring plans
  • To monitor recruitment / sample collection and assist with site payments, if appropriate
  • To perform Source Data Verification (SDV) of study data at participating sites to check original source documents against what has been entered into the study database
  • To perform remote monitoring of studies via the online study database to identify, raise and resolve queries in between monitoring visits
  • To check patient informed consent forms, ISFs and Serious Adverse Events (SAEs) for accuracy and completeness on study visits
  • To perform Site Initiation Visits and study closeout visits as required
  • To write reports and follow up letters to sites following site visits and to monitor and record follow up of action points resulting from those visits
  • To raise any areas of concern identified at site visits with the Clinical Trial Manager, Operations Manager and/or QA Manager as appropriate
  • To distribute and supervise all study documentation and equipment required for the purpose of the study
  • To arrange with study staff for the creation and maintenance of patient files and study documentation
  • To collaborate with pharmacies for the distribution, receipt, storage, stock control and disposal of study drugs under the direction of the Clinical Trial/Operations Managers and check this is in place on site visits
  • To facilitate the correct completion of patient record forms, and to investigate missing forms
  • To maintain patient confidentiality at all times
  • To maintain a log of patient status in assigned sites
  • To liaise with the relevant laboratories as required

Immediate Start please email henry@pop-science.co.uk or call 07956017160 if you're interested.

#CDAs #clinicalmonitor #CRA #contract #TMF #ICHGCP

Apply Later
Sign in
Similar Jobs
  • Senior Implementation Consultant
    Rest of World, EMEA (other)
    £50k - 60k per year

    Are you a technical or clinical data manager, who loves building innovative systems and helping to mentor others? We've got a great Risk Based Quality Management Implementation Consultant role, ideally based in Cambridge.

    Our client is growing at pace due to the success of their Industr...

  • Software Validation Lead
    Rest of World, EMEA (other)
    £40k - 55k per year

    We are looking for a Validation Lead candidate to join our client who is a leader in software supporting clinical trials. Normally this is office based in Cambridge, but currently home working.

    The role is a key function in their SDLC and client project delivery models. Our SDLC follows an ...

  • Implementation Consultant
    Rest of World, EMEA (other)
    £45k per year

    Are you a technical or clinical data manager, who loves building innovative systems, looking for a move into technology? We've got a great Risk Based Quality Management Implementation Consultant role, ideally based in Cambridge.

    Our client is growing at pace due to the success of their ...

Email Me Jobs Like This
Subscribed to similar jobs notifications
We use cookies to provide you with the best possible browsing experience on our website. You can find out more below.
Cookies are small text files that can be used by websites to make a user's experience more efficient. The law states that we can store cookies on your device if they are strictly necessary for the operation of this site. For all other types of cookies we need your permission. This site uses different types of cookies. Some cookies are placed by third party services that appear on our pages.
Necessary cookies help make a website usable by enabling basic functions like page navigation and access to secure areas of the website. The website cannot function properly without these cookies.
ResolutionUsed to ensure the correct version of the site is displayed to your device.
SessionUsed to track your user session on our website.
Statistic cookies help website owners to understand how visitors interact with websites by collecting and reporting information anonymously.
Google AnalyticsGoogle Analytics is an analytics tool to measure website, app, digital and offline data to gain user insights.
Money Penny

More Details