Danielle Allison Email & Phone Number

Newcastle Upon Tyne, Gb

Stockton-On-Tees, England, United Kingdom

• Act as a quality specialist on several studies at a site to ensure the successful delivery of projects.• Participate in start-up, set-up and close out of studies from a quality perspective, ensuring adherence to the Protocol and GCP requirements.• Track the flow of the CRF’s, queries and patient recruitment status.• Ensure protocol visit windows are scheduled according to the protocol requirements and report deviations.• Review Investigator Site File, ensuring is remains… Show more • Act as a quality specialist on several studies at a site to ensure the successful delivery of projects.• Participate in start-up, set-up and close out of studies from a quality perspective, ensuring adherence to the Protocol and GCP requirements.• Track the flow of the CRF’s, queries and patient recruitment status.• Ensure protocol visit windows are scheduled according to the protocol requirements and report deviations.• Review Investigator Site File, ensuring is remains accurate and complete• Manage study trackers for patient recruitment and study flow. • Review informed consent forms for completion and escalate concerns.• Assist with archiving procedures and act as site lead archivist. • Frequently liaises with monitors and client representatives, completing the preparation for monitoring visits. • Prepare site for any regulatory inspections or audits on an internal and external level.• Highlight any auditor findings and propose RCA and CAPA actions.• Identify and report quality issues, supporting and mentoring other staff members in this process.• Ensuring adherence to rules and regulations of ICH. GCP and other regulatory and ethical guidelines and data protection regulations.• Reports any non-compliance to protocol via internal and sponsor level requirements. Show less

• Act as a quality specialist on several studies at a site to ensure the successful delivery of projects.• Participate in start-up, set-up and close out of studies from a quality perspective, ensuring adherence to the Protocol and GCP requirements.• Track the flow of the CRF’s, queries and patient recruitment status.• Ensure protocol visit windows are scheduled according to the protocol requirements and report deviations.• Review Investigator Site File, ensuring is remains… Show more • Act as a quality specialist on several studies at a site to ensure the successful delivery of projects.• Participate in start-up, set-up and close out of studies from a quality perspective, ensuring adherence to the Protocol and GCP requirements.• Track the flow of the CRF’s, queries and patient recruitment status.• Ensure protocol visit windows are scheduled according to the protocol requirements and report deviations.• Review Investigator Site File, ensuring is remains accurate and complete• Manage study trackers for patient recruitment and study flow. • Review informed consent forms for completion and escalate concerns.• Assist with archiving procedures and act as site lead archivist. • Frequently liaises with monitors and client representatives, completing the preparation for monitoring visits. • Prepare site for any regulatory inspections or audits on an internal and external level, having previously aided in the preparation and daily requirements of an MHRA inspection, Sponsor Audits and multiple internal audits.• Highlight any auditor findings and propose RCA and CAPA actions.• Identify and report quality issues, supporting and mentoring other staff members in this process.• Ensuring adherence to rules and regulations of ICH. GCP and other regulatory and ethical guidelines and data protection regulations.• Reports any non-compliance to protocol via internal and sponsor level requirements. Show less

• Act as a quality specialist on several studies at a site to ensure the successful delivery of projects.• Participate in start-up, set-up and close out of studies from a quality perspective, ensuring adherence to the Protocol and GCP requirements.• Track the flow of the CRF’s, queries and patient recruitment status.• Ensure protocol visit windows are scheduled according to the protocol requirements and report deviations.• Review Investigator Site File, ensuring is remains… Show more • Act as a quality specialist on several studies at a site to ensure the successful delivery of projects.• Participate in start-up, set-up and close out of studies from a quality perspective, ensuring adherence to the Protocol and GCP requirements.• Track the flow of the CRF’s, queries and patient recruitment status.• Ensure protocol visit windows are scheduled according to the protocol requirements and report deviations.• Review Investigator Site File, ensuring is remains accurate and complete• Manage study trackers for patient recruitment and study flow. • Review informed consent forms for completion and escalate concerns.• Assist with archiving procedures and act as site lead archivist. • Frequently liaises with monitors and client representatives, completing the preparation for monitoring visits. • Prepare site for any regulatory inspections or audits on an internal and external level, having previously aided in the preparation and daily requirements of an MHRA inspection, Sponsor Audits and multiple internal audits.• Highlight any auditor findings and propose RCA and CAPA actions.• Identify and report quality issues, supporting and mentoring other staff members in this process.• Ensuring adherence to rules and regulations of ICH. GCP and other regulatory and ethical guidelines and data protection regulations.• Reports any non-compliance to protocol via internal and sponsor level requirements. Show less

• Act as a quality specialist on several studies at a site to ensure the successful delivery of projects.• Participate in start-up, set-up and close out of studies from a quality perspective, ensuring adherence to the Protocol and GCP requirements.• Track the flow of the CRF’s, queries and patient recruitment status.• Ensure protocol visit windows are scheduled according to the protocol requirements and report deviations.• Review Investigator Site File, ensuring is remains… Show more • Act as a quality specialist on several studies at a site to ensure the successful delivery of projects.• Participate in start-up, set-up and close out of studies from a quality perspective, ensuring adherence to the Protocol and GCP requirements.• Track the flow of the CRF’s, queries and patient recruitment status.• Ensure protocol visit windows are scheduled according to the protocol requirements and report deviations.• Review Investigator Site File, ensuring is remains accurate and complete• Manage study trackers for patient recruitment and study flow. • Review informed consent forms for completion and escalate concerns.• Assist with archiving procedures and act as site lead archivist. • Frequently liaises with monitors and client representatives, completing the preparation for monitoring visits. • Prepare site for any regulatory inspections or audits on an internal and external level, having previously aided in the preparation and daily requirements of an MHRA inspection, Sponsor Audits and multiple internal audits.• Highlight any auditor findings and propose RCA and CAPA actions.• Identify and report quality issues, supporting and mentoring other staff members in this process.• Ensuring adherence to rules and regulations of ICH. GCP and other regulatory and ethical guidelines and data protection regulations.• Reports any non-compliance to protocol via internal and sponsor level requirements. Show less

Hexham

• Work on several studies at a site to ensure the successful delivery of projects.• Participate in start-up, set-up and close out of studies from a quality perspective, ensuring adherence to the Protocol and GCP requirements.• Track the flow of the CRF’s, queries and patient recruitment status.• Ensure protocol visit windows are scheduled according to the protocol requirements and report deviations.• Review Investigator Site File, ensuring is remains accurate and… Show more • Work on several studies at a site to ensure the successful delivery of projects.• Participate in start-up, set-up and close out of studies from a quality perspective, ensuring adherence to the Protocol and GCP requirements.• Track the flow of the CRF’s, queries and patient recruitment status.• Ensure protocol visit windows are scheduled according to the protocol requirements and report deviations.• Review Investigator Site File, ensuring is remains accurate and complete• Manage study trackers for patient recruitment and study flow. • Review informed consent forms for completion and escalate concerns.• Assist with archiving procedures.• Frequently liaises with monitors and client representatives, completing the preparation for monitoring visits. • Identify and report quality issues.• Ensuring adherence to rules and regulations of ICH. GCP and other regulatory and ethical guidelines and data protection regulations.• Reports any non-compliance to protocol via internal and sponsor level requirements. Show less

Hexham

Working in a small but busy lab processing biological samples and preparing them for shipment to the central labs. Also aiding and supporting colleagues to maintain a clean, professional environment. Adhering to study specific protocol requirements following the correct study specific lab manuals.Ordering of clinical supplies and equipment, ensuring accurate records are kept and all equipment meets required guidelines. Carrying out patient health check visits, obtaining… Show more Working in a small but busy lab processing biological samples and preparing them for shipment to the central labs. Also aiding and supporting colleagues to maintain a clean, professional environment. Adhering to study specific protocol requirements following the correct study specific lab manuals.Ordering of clinical supplies and equipment, ensuring accurate records are kept and all equipment meets required guidelines. Carrying out patient health check visits, obtaining blood samples and vitals when needed and obtaining an ECG when required. Leasing with other members of the team and colleagues across the UK to ensure efficiency and a consistent working practice. Show less

Bsc Crime Science, Bsc Crime Science, 2:1

A relatively new degree study area, looking at environmental factors that affect crime rates. Study areas included: Crime Prevention/.

A Levels, Law, Chemistry And Sociology

Gcse, Gcse