Phyllis Davidson, Mba, Ccrp, Emt-B Email & Phone Number

Pittsburgh, Pa, Us

Bethesda, Md, Us

Bethesda, Md, Us

Durham, North Carolina, Us

Durham, North Carolina, Us

•Responsible for performing clinical lead tasks.•Provide regular status updates to the Project Manager and Upper Management for client reports.•Provide regular status updates to the Sponsor team.•Review trip reports and work with responsible CRA to ensure necessary revisions are made and reports are submitted to the sponsor and eTMF within contractual timelines.•Review ICFs prior to submission to local IRBs to ensure appropriate language per ICH GCP, local regulations, and company policy.•Draft country level ICF template and distribute to study sites.•Ensure study team members have completed all applicable study-required training, and provide training when necessary.•Develop and update trackers to capture important information across the study team.•Responsible for overseeing eTMF quality audits and working with appropriate team members to ensure all required documentation is filed per company SOPs.•Develop a TMF/ISF tracker for study team use to ensure that all documentation between the site file and the Sponsor TMF is consistent and up-to-date.•Prepare for and conduct all site visits including, but not limited to, qualification visits, initiation visits, monitoring visits, motivational visits, audit support visits, and close-out visits according to relevant SOPs.•Identify potential centers for a proposed study in conjunction with the Project Team, and conduct feasibility assessment of sites as required.•Ensure that investigator site files are assembled appropriately and that all required documentation is in place prior to release of clinical supplies.•Prepare or facilitate the preparation of Multicenter IRB submission documentation as defined by local requirements. Ensure that IRBs are updated regarding protocol amendments, SAEs, etc.•Deal with local or central laboratories in order to ensure adherence to the protocol. Ensure that all relevant documentation is current e.g., accreditation certificates, normal ranges, etc.

Wilmington, Nc, Us

Senior Clinical Research Associate (April 2015 - November 2015)•Responsible for performing clinical lead tasks•Provided regular status updates to Clinical Team Manager/Project Manager for client reports•Provided regular status updates to the Sponsor team•Drafted Monitoring Plan, eCRF guidelines, and other study documents, as required •Sole CRA responsible for conducting End User Testing between the company’s old CTMS system and the new CTMS system•Tracked study-specific status reports to ensure all required information regarding site issues, deviations, and CRF statuses are kept current •Performed Serious Adverse Event reconciliation and work with sponsor, study sites, and CRAs to resolve discrepancies•Reviewed outstanding data reports and work with CRAs to ensure data collection is met per contractual guidelines•Worked with the payments group to ensure sites are paid appropriately each quarter, per their contract•Served as mentor/trainer for less experienced CRAs to assist with general and study-specific monitoring issues•Provided direct support to the Clinical Team Manager/Project Manager by assisting with assigned managerial tasks•Performed all duties of a CRA as listed in job title below, serving as the primary contact with individual investigative sites that conduct clinical research for PPDClinical Research Associate II (September 2012 - April 2015)•Ran open query and outstanding eCRF reports through the EDC system and distributed to the study team for appropriate resolution•Drafted study newsletter to be provided to participating study subjects•Presented study-specific information to participating study sites at the Investigator’s Meeting•Assisted feasibility team with tasks, inclusive of CDA collection and survey response data•Performed and coordinated 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

Pittsburgh, Pennsylvania, Us

•Utilized Electronic Data Capture programs for Source Data Verification purposes•Processed site payments on a quarterly basis•Reviewed accuracy and completeness of site records, including regulatory binder documents, site study file, query resolutions, and other data collection tools•Verified that research site personnel were conducting the study according to protocol, Good Clinical Practices, and regulatory requirements•Conducted routine site visits

Las Vegas, Nevada, Us

Monitor for two multicenter Tinea Pedis studies with responsibility for 23 sites in the east region of the U.S. and Belize. Served as the primary contact with individual investigative sites.•Conducted routine Pre-Study Site Selection, Site Initiation, Site Monitoring, and Close-Out Visits•Verified that research site personnel were conducting the study according to protocol, Good Clinical Practices, and regulatory requirements•Ensured reporting of adverse events from the research site staff to the sponsor and the IRB•Reviewed accuracy and completeness of site records, including regulatory binder documents, site study file, query resolutions, and other data collection tools•Performed drug accountability of Investigational Product•Traveled 80-100% throughout US and Central America

Bachelor Of Arts (Ba), Biology, General

Master Of Business Administration - Mba, Project Management

Bachelor Of Arts (Ba), Foreign Languages And Literatures, General