Are you a Clinical Trial Monitor or Clinical Research Associate looking for a 4-6 month role? We have a great opportunity working on an industry-sponsored, multi-centre, cardiovascular observational study in the UK. This will involve site set-up including feasibility, initiation, monitoring recruitment and follow-up, maintenance of the trial master file and close-out and archiving, with guidance from the Clinical Trial Manager and Operations Manager.

The post holder will oversee study set-up, the progress and performance of the investigator sites, including efficient recruitment and reliable data collection to ensure the study is conducted in accordance with contractual agreements, trial protocol, trial-specific processes and systems, SOPs, regulatory and ethical requirements and ICH-GCP.

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 undertake site selection and feasibility activities with all potential study sites to ensure they are suitable for participation in the study

· 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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