***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.

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