Chelsea Phillips Email and Phone Number

Coordinates all monitoring aspects in the execution and support of clinical trial activities. Responsibilities including but not limited to:•Supervises and ensures CRA team members are compliant with SOPs, sponsor and regulatory agency expectations for site monitoring activities•Participates on internal, site and sponsor teleconferences and meetings to address monitoring activities outlined in statements of work•Critically reviews study protocols, study documents, monitoring reports and Sponsor required plans for communication, monitoring and other required plans•Implements full scope and risk-based monitoring programs•Develops and implements tracking systems for key monitoring activities and evaluates defined milestones for these activities•Reviews and approves travel, expense report and timesheets•Conducts co-monitoring activities (feasibility, qualification or selection, interim, close out visits, for cause and other visits) as required•Participates as a team leader in project planning, implementation, problem solving, tracking milestones and deliverables•Liaises with the Sponsor and the study team•Leads in the development of key monitoring deliverables such as clinical monitoring plans and site visit report templates•Helps to identify, train, and mentor new CRAs and monitoring staff•May prepare monitoring budgets and statements of work for existing and new proposals

Responsible for all activities related to implementation and execution of clinical studies that included both global and us only early phase oncology trials. Key responsibilities were but not limited to:Work with Project Manager (PM) to define program targets for clinical monitoring staff and assure work is documented within contracted project scope. Communicate and document all interactions with client as required by SOP. • Serve as client advocate within IQVIA Biotech. • Develop and implement Clinical Monitoring Plan. Team Duties/Responsibilities: Responsible for assuring needs of clinical sites are met by facilitating clinical monitoring processes, including: Coordinate site management activities:• Site identification, recruitment, and selection. • Regulatory document collection and review. • Overall scheduling and management of all site visits. • Develop site/monitoring tools and training materials. • Review and identify trends in enrollment and data entry at sites and proactively interface with clinical monitoring team and client to identify solutions. Coordinate and oversee daily operations of clinical monitoring team: • Set and enforce project timelines with the assigned study team. • Coordinate remote review of clinical data within EDC system. • Oversee monitoring visit schedule to ensure compliance with frequency set forth in contract. • Review and approve trip reports and follow-up letters within required timeframe. • Schedule and manage weekly CRA project team meetings.• Ensure CRAs assigned to team receive therapeutic and project-specific training. • Manage quality and regulatory compliance among clinical monitoring team and investigational sites. Manage project milestones and proactively address deficiencies

Focused in Early Phase oncology trials and included but not limited to the following responsibilities:•Participates in the investigator recruitment process and site qualification visits. •Performs study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the eCRF; monitoring activities and study close-out activities.•Assures adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits. •Documents accountability, stability and storage conditions of clinical trial materials as required by sponsor. Performs investigational product inventory.•Reviews the quality and integrity of the clinical data through (1) in house review of electronic CRF data and (2) on-site source verification. Works with sites to resolve data queries.•Review protocols, eCRFs, study manuals and other related documents, as requested by the Clinical Trial Manager•Serves as primary contact between IQVIA Biotech and investigator; coordinates all correspondence; ensures timely transmission of clinical data with the study site and technical reporting, as requested.•Performs study close-out visits per the study specific Clinical Monitoring Plan including final investigational product reconciliation and disposition, site study file reconciliation, data query resolution through to database lock and resolution of outstanding action items.•Authorized to request site audits due to data integrity concerns.•Ensures internal and study-related trainings are completed per IQVIA Biotech and/or study timelines; CTMS should always be current with the pertinent site updates/contacts.•Ensures all study deliverables are completed per IQVIA Biotech and study timelines•Conducts Field Evaluation Visits and field training of CRA Is, IIs and other Sr. CRAs.•Serves as mentor for junior CRAs and those new to the company and/or study.

Primarily based in Early Phase Oncology trials. My therapeutic experience includes Pancreatic, Glioblastoma, Non-Small Cell Lung Cancer, Small Cell Lung Cancer, Liver Carcinoma, GI/GU Carcinomas, Melanoma, Rare Disease, Ophthalmological carcinomas, Breast Carcinoma (TNBC,ER +/HER2-), Ovarian Carcinoma, Prostate Cancer, Acute Myeloid Carcinoma, and Acute Leukocyte Carcinoma.

Supported onsite monitoring for Investigator Initiated Trials and Biopharma trials while included some of the following responsibilities:•Completed multiple initial on-site site evaluations to help UPMC identify eligible and competent investigators for linked academic sites. This included, but was not limited to traveling to potential sites, discussing previously sent protocol, capabilities of the facility, and first contact with investigator’s team•Performing on-site and/or teleconference site initiation training visits, and continuation of training on new amendments and modifications•Responsible for ensuring that training is relevant, and all appropriate investigators and staff are properly listed on the delegation log•Performing regulatory reconciliation of essential documents during each interim monitoring visits•Confirming and verifying that necessary safety procedures have been followed per Institutional Review Board (IRB) reporting guidelines•Assess that all trial specific safety and ICH-GCP guidelines are adhered to at all investigational sites• Performing weekly contact calls with sites to collaborate and inform contacts with deadlines, escalated queries, and future data cuts and/or data locks•Perform source document verification through paper source and electronic medical records•Collaborate with investigational site team to facilitate query resolution, timely data entry, and proper conduct of clinical trials

Supporting multiple clinical trials within oncology (Pancreatic, Liver, Kidney) and traveling CRAs. Responsibilities included:•Multiple responsibilities including the following - protocol writing, prescreening of potential patients, consenting in compliance with state and federal regulations, data entry, assessing adverse events and serious adverse events, compliance with all monitoring and auditing procedures, conducting investigational trial procedures, preparing for publication, and study closure requirements•CRA dedicated-role included production, review, & confirmation of appropriate source documentation, adherence to state and federal clinical trial requirements, providing staff & site training, on-site monitoring, and a primary resource for newly acquired linked academic centers and community sites•Completed required ICH-GCP education, oncology regulations, and regulatory/safety procedures•Responsible for ensuring that training is relevant, and all appropriate investigators and staff are properly listed on the delegation log•Performing regulatory reconciliation of essential documents during each interim monitoring visits•Confirming and verifying that necessary safety procedures have been followed per Institutional Review Board (IRB) reporting guidelines•Assess that all trial specific safety and ICH-GCP guidelines are adhered to at all investigational sites•Performing weekly contact calls with sites to collaborate and inform contacts with deadlines, escalated queries, and future data cuts and/or data locks