John Field

Background

About John Field

Perform and coordinate assigned aspects of the clinical monitoring process in accordance with GCPs and global SOPs to assess the safety and efficacy of investigational products and/or medical devices. Conduct site visits to determine protocol and regulatory compliance, and prepares required documentation. Develop collaborative relationships with investigative sites and client company personnel. Accountable for the review and transmission of regulatory documents and negotiation of clinical study agreements, budgets and investigator grants. Implement project plans with specific guidelines and accountable for meeting applicable project timelines. Collaborate with study team to ensure accuracy of investigator files and prepares for audit readiness. Perform file reviews for PPD investigator files and site files. Accountable for generating, resolving and clarifying queries and regulatory documents. Accountable for meeting applicable project timelines in accordance with the master contract. Facilitate effective communication between project team and any auxiliary team members (e.g. vendors and or third party vendors) in order to anticipate, identify and resolve clinical trial issues. Able to perform drug accountability for clinical trials as contracted by client, including report preparation and submission to client company within specified timelines Observe site visits with experienced CRA’s (write draft trip reports, follow up letters and confirmation notices to correspond with on site visit observation). Manage study data including the review and tracking of study documents to ensure completeness and accuracy. Utilize document tracking systems effectively in order to ensure adequate communication to project. Created study specific process documents. Organized meetings through Meeting Place and generated meeting minutes respectively. Responsible for maintaining organized home office and meeting sponsor and internal deliverables in a timely fashion. Specialties: Clinical Research, Computer Systems, Mentoring