Clinical Research Monitor – closing date 16 July

Location
Welwyn Garden City Hertfordshire
Description & contact details
THIS IS A READVERTISEMENT. PREVIOUS APPLICANTS NEED NOT APPLY.
We are looking for an enthusiastic and capable clinical research
monitor to join our growing team. The post holder will work mainly
across UK, academic clinical trials.
You will be involved in supporting the identification of
investigational sites, conduct qualification/feasibility visits (QV),
site initiation visits (SIV) and monitoring visits (MV) at assigned
clinical sites in accordance with PHARMExcel Ltd Standard Operating
Procedures (SOPs) and policies, International Conference on
Harmonisation (ICH) and Good Clinical Practice (GCP) guidelines, ISO
14155 (GCP medical devices), European Union Directives (Drugs and
Devices) , UK legislations (Drugs and Devices) requirements.
Act as PHARMExcel’s direct contact with sites and use judgment to
assess and ensure overall integrity of study implementation, as well
as adherence to study protocols. Build strong working relationships
with investigators and site staff. Manage clinical monitoring
activities, including: Arranging on-site visits and logistics.
Establishment of site recruitment plans in collaboration with site
staff during QV. Monitoring completeness and quality of regulatory
documentation. Performing site documentation verification (SDV), data
collection and drug/device accountability activities. Monitoring
patient safety on-site and addressing any violations in a timely
manner.
You will also be involved in supporting the Study Co-ordinators to
undertake Ethics and Regulatory submissions as required.
Interviews will be held the w/c 23rd July 2018
A copy of the Job Description is available via Samantha Males on
Closing Date:
16/07/2018

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