Cheryl Bernier Email and Phone Number

Perform on site or remote Quality Visits, to ensure compliance with regulations and SOPS at clinical sites. After visit, identify training needs, developmental areas and complete an action plan.Support sponsor and sites before/during/after health authority inspections.Support during sponsor-initiated audits.Facilitate discussion at Whiteboard meetings and of GxP support mailbox triage.Respond to questions sent to shared GxP Mailbox on wide variety of topics related to GCP and GDP.QC including Informed Consent forms, patient diaries, training slide decks, study start up documents, and Background Checks.Quality process development and improvement, and leading initiatives.Certified Lead Auditor for vendor and remote pharmacovigilance (PV) auditsConduct PV and GDP Vendor Audits according to Audit PlanConduct sales rep refrigerator temperature monitoring, replacement thermometer process review and thermometer calibration certificate reviewSerious Breach reporter for US and Canada

* Prepare and conduct new hire training on PRAHS and Strategic Solutions’ expectations, systems, SOPs as well as new hire training for an assigned Sponsor on Sponsor expectations, systems, & SOPs.* Develop, conduct and continually improve training on new procedures, processes and systems for existing staff as appropriate via net meetings, web conferencing or face to face* Conduct trending analyses on data collected through QC activities and identify areas of potential training needs * Provide compliance support by answering questions or providing advice on ICH/GCP, SOPs, local regulations and guidelines* Develop, maintain, distribute, and continually improve tools (e.g. Quick Reference Guides, Checklists, etc.) to improve field staff efficiency or compliance* Develop, coordinate, and host regular continuing education and development opportunities for Strategic Solutions’ staff* Develop and continually improve quality control measures for Sponsor services, including standard quality checks* Collect and analyze qualitative and quantitative results from quality checks and report results to leadership team* Conduct Quality Control activities on selected service areas as needed to assess quality deliverables* Track and report quality metrics to leadership team at regular intervals* Provide input into metric improvement efforts* Identify need and assist with implementation of process and efficiency improvements* Support field team in preparing for external audits* Responsible for drafting and maintaining a Quality Plan for an assigned program* Assigned 1 - 2 study sites to manage as a CRA

* Implements and monitors clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH-GCP guidelines* Assesses the qualification of potential investigative sites, initiates clinical trials at investigative sites, instructs site personnel on the proper conduct of clinical trials, and close clinical trials at investigative sites*Reviews and verifies accuracy of clinical trial data collected, either onsite or remotely* Provides regular site status information to team members, trial management, and updates trial management tools* Completes monitoring activity documents as required by PRA SOPs or other contractual obligations* Works closely with other clinical team members to facilitate timely resolution of trial and/or clinical issues* Escalates site and trial related issues per PRA SOPs, until identified issues are resolved or closed* Performs essential document site file reconciliation* Performs source document verification and query resolution* Assesses IP accountability, dispensation, and compliance at the investigative sites* Verifies Serious Adverse Event (SAE) reporting according to trial specifications and ICH-GCP guidelines* Communicates with investigative sites* Updates applicable tracking systems* Ensures all required training is completed and documented* Serves as observation visit leader* Facilitates audits and audit resolution* Mentors junior level CRAs and serves as a resource for new employees* Assigned additional Clinical Operations tasks* Serve as a resource for and interact with other functional areas to resolve site issues and facilitate trial timelines

• Independently perform and organize remote clinical monitoring tasks and remote visits for designated projects in accordance with relevant SOPs, study specific guidelines and regulations.• Managing/supporting clinical monitoring activities remotely, including but not limited to issue resolution, patient enrollment management, handling protocol-and/or contract amendments and ensuring timely, high quality data entry at site level.