Clinical Trials Monitor

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Job description

We've got a great role for a CRA working with client who are a world leading clinical research team. They are based in West London so would ideally be able to get there at last 1 day per week.

We can consider part time CRAs for this role too.

*Key Responsibilities*

(TMFs) and Site Master Files (SMFs) as well as creation and distribution to sites of the Investigator

Site Files (ISFs).

- To set up and attend regular meetings with study staff, through a combination of meetings in

person and via teleconference, with staff at the coordinating 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, both remote and on-site, 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 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 well as assist at any country wide study

meetings, 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.

Job Description

- To offer administrative support as required by the Clinical Trial Manager, Commercial Operations

Manager and the Unit Directors, including support and guidance to less experienced monitors and

administrators.

- To represent ICTU in a professional manner at all times.

Other Duties

- To undergo training deemed to be necessary for the full execution of trial duties.

- To assist with the preparation and conduct for any future GCP Inspection.

- To participate in study meetings and activities with commercial Sponsors, including bid defense

meetings for studies ICTU is seeking to manage.

- To perform any other duties which may be required that are consistent with the nature and grade of

the post as required by the Clinical Trial Monitor, Operations Manager or Director of

Pharmaceutical Liaison.

- To ensure familiarity with and adherence to all relevant ICTU SOPs and the SOPs of partner

organisations.

- To be responsible for ensuring that data is accurate, up-to-date and complete

#'TMF #SiteMasterFiles #SMF as well as creation and distribution to sites of the #InvestigatorSiteFiles #ISF