Paul Morrison Email & Phone Number

Pharmaceutical and Medical Device research and development consultant

Deerfield, Illinois, US

• Review of protocols and other study documents
• Monitoring clinical research sites' continued qualification for conduction and participation in clinical research (documented IRB initial and continued review and approval to conduction clinical research and review and.
• Conducting site qualification visits, site initiation visits, interim monitoring visits and close-out visits
• Recording the conduction of site visits in accordance with the monitoring plan and in accordance with appropriate visit report template(s)
• Conducting non-in-person site reviews and recording in accordance with monitoring plan using the proper template
• Conducing verbal communications, written communications and any other form of communication with clinical research sites in accordance with monitoring plan, using the proper template(s)

Raleigh, North Carolina, US

• Complete project activities associated with monitoring functions of Phase I-IV clinical research studies while demonstrating mastery and a deep understanding of the drug development process, Good Clinical Practices.
• Provide clinical and technical support for Clinical Research Associates (CRA) I, II, and III and administrative staff
• Perform management of study site activities to ensure the integrity of clinical data, in adherence to all applicable regulatory guidelines and Standard Operating Procedures (SOPs) and Project Specific Operating.
• Responsible for site management and site staff performance including: monitors all types of clinical trials; participates in all types of site visits; assures compliance with all protocol requirements; assures.
• Complete and submit reports according to SOP/Works Instructions (WI) or Sponsor requirements requiring minimal revisions. Maintains awareness of key study performance indicators for own sites, e.g. Telephone.
• Update study and patient status information and serves as Clinical Trial Management System resource for Project Manager (PM)/Lead CRA, track Investigator payments/milestones

• Assist with protocol and CRF development and review
• Develop informed consent forms
• Conduct study feasibility and site selection activities
• Assist with the development of study manuals, annotated CRFs, monitoring conventions, tracking forms, site study tools, and other study materials
• Develop and implement innovative approaches for and participates in site recruitment, selection and initiation activities.
• Conduct site management activities, including but not limited to site selection visits, site initiation visits, site training, site routine monitoring visits, and site close out visits.

Raleigh, North Carolina, US

• Implements and monitors clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH guidelineso Visits sites to assess the.
• Performs investigative site file reconciliation; requests any new or updated site-related essential and non-essential documents and reviews them for content, consistency with other documents, and compliance with.

Princeton, New Jersey, US

• Acted as the North American Lead CRA with regards to recruitment and vendor management for a large global oncology study. Conducted on-site Recruitment Specialist visits to help Investigator’s set-up and carry out.
• Maintained responsibility for all aspects of study site monitoring including routine monitoring visits and close-out of clinical sites, maintained study files, conducted pre-study and initiation visits; liaised with.
• Conducted General On-Site Monitoring Responsibilities:o Ensured the study staff received the proper materials and instructions to safely enter patients into the study protocolo Assured the protection of study patients.
• Performed CRF review, query generation and resolution against established data review guidelines on Covance or client data management systems
• Attended and presented at investigators’ meetings, project team meetings and teleconferences
• Managed the administration of clinical research projects, recruiting investigators, collecting investigator documentation and site management