• Performs Selection, Initiation, Monitoring and Closure Visits at Investigator Sites according to project schedule. Adheres to project guidelines.• Monitors activities at clinical study sites to assure adherence to GCP, ICH, SOPs, and study protocols.

Performs Selection, Initiation, Monitoring and Closure Visits at Investigator Sites according to project schedule. Adheres to project guidelines.Monitors activities at clinical study sites to assure adherence to GCP, ICH, SOPs, and study protocols.Tracks and supervises collection of ongoing study data for purpose of regular project status reporting.Collects and reviews regulatory documents as required.Prepares site visit reports and telephone contact reports.Resolves site… Show more Performs Selection, Initiation, Monitoring and Closure Visits at Investigator Sites according to project schedule. Adheres to project guidelines.Monitors activities at clinical study sites to assure adherence to GCP, ICH, SOPs, and study protocols.Tracks and supervises collection of ongoing study data for purpose of regular project status reporting.Collects and reviews regulatory documents as required.Prepares site visit reports and telephone contact reports.Resolves site issues, including site recruitment challenges, and determines status for IP shipment.Assists the Project Manager (PM), Clinical Team Leader and/or Lead CRA (CTL/LCRA) with generation of study specific forms for completion by CRA and Investigators and follow up with the teams to ensure timely completion and submission.Works with PM/CTL/LCRA to secure authorization of site contracts.Informs team members of completion of regulatory and contractual documents for individual sites.Identifies the documentation required for review by Regulatory Authorities and Ethical Committees. Prepare Regulatory and Ethics Committee submissions. Ensure written approvals are obtained and distributed appropriately prior to Site Initiation.Prepares and attends an Assessment Visit with a more senior CRA, CTL or Clinical Research Manager as required. Show less

• Responsible for booking and setting up meetings and conferences calls, attend meetings as required; prepare agendas, capture minutes, distribute reports and follow up where necessary.• Acted as the first point of contact with both internal and external connection, screening telephone calls and handling queries.• Responsible for secretarial duties including ordering stationeries, typing, photocopying, scanning of documents into system and filing hard copies.• Responsible for… Show more • Responsible for booking and setting up meetings and conferences calls, attend meetings as required; prepare agendas, capture minutes, distribute reports and follow up where necessary.• Acted as the first point of contact with both internal and external connection, screening telephone calls and handling queries.• Responsible for secretarial duties including ordering stationeries, typing, photocopying, scanning of documents into system and filing hard copies.• Responsible for chasing up purchase order fulfilment and liaising with courier service.• Made travel arrangement for Managers. Show less

• Assisting with the smooth day-to-day running and completion of the qualitative element of the research project by supporting the trial manager and Chief Investigator.• Undertaking recruitment, data collection, analysis, the production of reports and summaries, using IT and statistical programmes.• Ensuring that research procedures (including consent processes and follow up) are carried out according to the approved protocol and the UK policy framework for health and social care… Show more • Assisting with the smooth day-to-day running and completion of the qualitative element of the research project by supporting the trial manager and Chief Investigator.• Undertaking recruitment, data collection, analysis, the production of reports and summaries, using IT and statistical programmes.• Ensuring that research procedures (including consent processes and follow up) are carried out according to the approved protocol and the UK policy framework for health and social care research. Show less

• Assisting, where appropriate, with data collection for audit purposes and data entry.• Booking patients visits, responding to basic queries and sending standard communications,• Supporting laboratory team(s) with bulk administrative tasks, if required (e.g., sample record-keeping, data entry/data checks)• Complying with regulatory and legislative requirements for clinical research.• Liaising with Team Leads and clinicians.• Call handling, negotiating with suppliers and… Show more • Assisting, where appropriate, with data collection for audit purposes and data entry.• Booking patients visits, responding to basic queries and sending standard communications,• Supporting laboratory team(s) with bulk administrative tasks, if required (e.g., sample record-keeping, data entry/data checks)• Complying with regulatory and legislative requirements for clinical research.• Liaising with Team Leads and clinicians.• Call handling, negotiating with suppliers and dealing with sensitive and confidential information.• Ordering and monitoring of equipment and stores.• Responding to a high volume of emails daily and organising them accordingly. Show less