In this context, as a client, you expect:

•       Positive, results orientated work environment, building partnerships and modelling teamwork, communicating to the team in an open, balanced and objective manner

•       Ownership for all project activities, which are related to the monitoring function

•       Identification and qualification of potential investigators to ensure that the sites have adequate time and can fulfil their obligation to the study

•       Preparation and submission of Regulatory and EC issues or providing support for undertaking Regulatory and EC submissions and in the generation of Financial Agreements according to standard and local country practices. Ensure that documents are collected in a timely manner in order to meet regulatory and ethics committee or IRB submission dates

•       Initiation of investigational sites, including site  personnel  training to ensure that investigators and other study personnel have a thorough understanding of the clinical protocol and that they understand their obligations to conduct a clinical trial as required by applicable regulations

•       Ongoing training to the site personnel with regards to ICH-GCP guidelines, our mca SOPs, or the client SOPs to ensure the quality and integrity of the data

•       Regular follow-up letters to the investigators and study personnel to ensure that they understand and follow up on all issues that occurred during the monitoring visits  

•       Ensuring that the site personnel are adhering to the protocol and addressing any issues concerning protocol non-compliance with the principal investigator

•       Ensuring effective and timely co-ordination of the supply of clinical materials to the site

•       Collaborating with other departments (e.g. Medical, Regulatory) to ensure that the principal investigator complies with the serious adverse event reporting requirements as defined by both the client and regulatory authorities within the specified time periods

•       Regular site visits to ensure that the site personnel are conducting the study in accordance with the protocol

•       Preparation and submission of visit reports in a timely manner according to mca SOPs or client SOPs as required

•       Managing and monitoring time budgeting, incorporating revenue recognition, to ensure that any potential cost over-runs are identified and addressed at an early stage

•       Interaction with investigators to obtain necessary documentation and information before, during and after the study. Ensure accurate inventory of central, investigator site and core files on an ongoing basis

•       Ongoing on site data management/ collection

•       Maintenance of project tracking systems on an ongoing basis, providing regular status updates

•       Assistance with the preparation and presentation at investigator meetings, as required

•       Assistance with the audit of an investigational site or central files

•       Attendance of staff meetings and training sessions as required