Beth Jackson Email & Phone Number

San Diego, Ca, Us

Horticultural Volunteer

Perform and coordinate all aspects of the clinical monitoring and site management process in accordance with ICH GCP, FDA guidelines, local regulations and PPD SOPs. Conduct site visits to assess protocol and regulatory compliance and manage required documentation Responsible for ensuring that data will pass international quality assurance audits. Represent PPD in the global medical research community and develop and maintain collaborative relationships with investigational sites and client company personnel. Assist project manager or clinical team manager on assigned projects and take a lead role where required. Support the line manager to mentor, train and contribute to the development of junior clinical team members.

Plan and conduct global laboratory audits at facility types ranging from central laboratories conducting endpoint and safety assays to satellite facilities conducting specimen processing and rapid assays. Audits involve the assessment of compliance with Good Laboratory Practices (GLP) as well as the Clinical Laboratory Improvement Amendments (CLIA). Write detailed laboratory audit reports that include comprehensive text surrounding all audit findings and a complete description of debriefing sessions performed at the conclusion of the audit. Conduct laboratory training for clients and internal employees as directed by the Laboratory Services Manager. Training includes regional laboratory training workshops worldwide with audiences up to 200 participants. The workshops include training on the fundamentals of Good Clinical Laboratory Practices (GCLP) to include Good Laboratory Practices (GLP) and the Clinical Laboratory Improvement Amendments (CLIA). Train junior laboratory audit staff in the field. Provide laboratory technical assistance to clients and internal employees, perform Quality Control checks on laboratory audit reports, and attend client/sponsor meetings as directed by the Laboratory Services Manger.

Perform and coordinate all 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 prepare required documentation. Represent PPD in the global medical research community and develops collaborative relationships with investigative sites and client company personnel. Perform the function of mentor for junior clinical team members. May assist the Project Manager, Senior Project Manager or CTM with certain project management functions.

Washington, District Of Columbia, Us

Served as Chairperson-Elect, Chairperson and Treasurer.

Us

San Diego, Ca, Us

Bachelor Of Science (B.S.), Microbiology, General

Certificate In Clinical Trials Managment, Clinical Trials Management