Carrie Hames Email & Phone Number

Cary, Nc, Us

Remote

• Oversee strategic planning and execution of complex global outsourced clinical trials.• Accountable for meeting all operational deliverables in accordance with time, cost, and quality commitments. • Contributes to the development of clinical asset life cycle and CDPs.• Establishes the operational plan and strategies including scenario planning, detailed timeline forecasts, program level feasibility, resourcing, and budget based on internal/external benchmarks.• Maintains an overview of study status and proactively communicates progress and issues that may impact timelines and costs of the program to all stakeholders.• Prepare and lead weekly CEO overviews and bimonthly CEO presentations on program strategy and status.• Budget forecasting and quarterly accrual management, drive change orders, oversee program level invoice management.• Oversee and assess vendor performance of timelines and deliverables via QTLs, risk overview, centralized monitoring, governance meetings and dashboard metrics.• Supervise clinical lead, project managers, and clinical trial assistant staff, including oversight of work assignment, performance, recruitment, and professional development.

Remote

• Led and optimized the performance of Local Study Teams, ensuring adherence to AZ Procedural Documents, ICH-GCP, and local regulations.• Oversaw clinical and operational feasibility assessments for potential studies.• Maintained the eTMF by overseeing team filing processes, completeness, and timelines• Set up and updated relevant systems for business-critical activities (e.g., Safety Reporting, Regulatory Submissions, Clinical Trial Transparency) and organized access at the country level.• Prepared forecasts for study timelines, resources, recruitment, budget, study materials, and drug supplies.• Developed, maintained, and reviewed risk management plans at the country level, proactively managing risks related to sites, stakeholders, vendors, and customers.• Oversaw and coordinated monitoring activities from site activation to study closure, ensuring compliance with Monitoring Plans.• Coordinated the site selection process, including identifying potential sites/investigators, performing initial Site Quality Risk Assessments, and overseeing Site Qualification Visits.• Collaborated with Regulatory Affairs to ensure timely submission of applications and documents to Regulatory Authorities throughout the study.• Managed the overall country budget, including reconciliations, invoices, and change orders; negotiated vendor contracts and prepared the country financial budget.• Oversaw local vendors from initiation through study completion.• Prepared key reports and presentations on study progress for senior management.

Durham, North Carolina

• Prepares key reports on study progress and updates to senior management.• Oversees study timelines.• Serves as primary interdepartmental contact for data management, safety, regulatory personnel, and other functional or departmental groups.• Provides clinical input in the development of case report forms, data management plan, and data listings review.​​​​​• Participates in vendor selection and contributes to the RFP process.​​​• Provides input for site, study and/or vendor specific budgets.• Leads meetings with CROs, vendors, and multi-functional teams.• Reviews site invoices.• Oversees vendor performance to ensure early risk mitigation/resolution serves in key role to develop/implement corrective action plans as appropriate.• Coordinates training of CRO staff, vendors, investigators, and study coordinators on study requirements and SOPs.​​​​​• Resolves escalated study conduct issues and provides clinical responses to questions from study centers and institutional review boards/ethics committees.​​​• Drafts, reviews and approves relevant documents, including informed consent, site worksheets, vendor site manuals (pharmacy, lab), monitoring reports.​​​• Ensures responses to site audits are adequately managed by designated clinical staff. ​• Oversees integrity of clinical data.• Oversee evaluation and clinical study set-up and follow-up study activities, as needed.​​​​• Monitors adherence to the regulatory/essential document collection process and release of clinical supplies.​​​​​• Plan and coordination of investigator meetings.• Oversee the trial master file.

Raleigh-Durham, North Carolina Area

• Vendor management of CRO clinical activities, home health research agencies, and other clinical research vendors • Develop and review clinical plans, templates, and guidelines (e.g. source documents, ICF templates, annotated TRs, SIV slides, clinical monitoring plans, newsletters, and eCRF guidelines)• Oversight of CRAs affiliated with CRO ensuring monitoring, study reporting, and EDC data review• Participate in CRF development, IVRS setup, central lab setup, and other vendor selection processes• Lead and coordinate recurring vendor meetings • Develop and maintain collaborative vendor relationships to manage study issues and support milestone achievement and convey project information• Approve sites for participation and study activation• Reconcile and approve vendor invoices• Review vendor report data and trip reports for completeness and accuracy• Track study specific tasks and progress of trials• Create internal study metric reports for upper management• Assist in the coordination, material development, and planning of meetings (e.g. Investigator Meetings, Kick-off meetings)• Conduct CRA training and monitoring observation visits• Understand and implement processes for distribution and tracking of SAEs, safety documentation, and pregnancies. Monitor compliance processes• Collaborate with data management to identify and correct EDC issues, conduct user testing and implementation of data checks and auto queries• Audit and monitor TMF study files (CRO TMF and on-site document reconciliation)• Assist with effective and timely audit/inspection responses

Research Triangle Park

• Vendor management of CRO clinical activities, home health research agencies, and other clinical research vendors • Develop and review clinical plans, templates, and guidelines (e.g. source documents, ICF templates, annotated TRs, SIV slides, clinical monitoring plans, newsletters, and eCRF guidelines)• Oversight of CRAs affiliated with CRO ensuring monitoring, study reporting, and EDC data review• Participate in CRF development, IVRS setup, central lab setup, and other vendor selection processes• Lead and coordinate recurring vendor meetings • Develop and maintain collaborative vendor relationships to manage study issues and support milestone achievement and convey project information• Approve sites for participation and study activation• Reconcile and approve vendor invoices• Review vendor report data and trip reports for completeness and accuracy• Track study specific tasks and progress of trials• Create internal study metric reports for upper management• Assist in the coordination, material development, and planning of meetings (e.g. Investigator Meetings, Kick-off meetings)• Conduct CRA training and monitoring observation visits• Understand and implement processes for distribution and tracking of SAEs, safety documentation, and pregnancies. Monitor compliance processes• Collaborate with data management to identify and correct EDC issues, conduct user testing and implementation of data checks and auto queries• Audit and monitor TMF study files (CRO TMF and on-site document reconciliation)• Assist with effective and timely audit/inspection responses

Raleigh-Durham, North Carolina Area

• Performed qualification, initiation, interim monitoring and closeout visits at clinical study sites for data collection, source data verification, SAE reporting, review of regulatory documents and drug accountability• Managed assigned study sites and trained site staff to ensure protocol and regulatory compliance • Generated study specific documentation including monitoring trip reports, telephone contact reports, and site correspondence • Recruited investigators for participation in clinical trials• Managed patient recruitment strategies to increase patient enrollment (e.g. investigator and SC meetings, newsletters, advertising, letters to GPs)• Served as a resource for new employees

• Performed investigator evaluation and recruitment• Assisted with Investigational Product accountability, subject screening/enrollment, Case Report Form retrieval, and query distribution to/retrieval from investigational sites• Performed essential document collection, review, maintenance and close out activities• Assisted with interviewing, managing, and training staff• Developed core informed consent templates for US based protocols• Tracked clinical trial management information in CTMS• Assisted with resolution of investigative site/data queries• Provided quality review of the informed consent template against local IRB requirements• Created and maintained clinical project documents, including project specific standard operating procedures under guidance Clinical Team Lead• Interacted with clients and vendors as secondary project contact for clinical issues

• Helped establish a 501c3 physician organization involving dermatologists and oncologists• Managed over $350,000 in society accounts including invoicing and transaction audits• Prepared annual budgets• Liaised with society lawyers to review and develop contracts, consulting agreements, administrative regulations, and bylaws• Completed and submitted educational and unrestricted grants• Organized and managed large educational meetings

• Site level project manager for over 15 clinical trials including large scale pharmaceutical sponsored trials (phase I-IV), investigator initiated studies, and databases for cutaneous lymphoma and alopecia • Clinical research unit manager for 7 clinical research employees including clinical research coordinators, research fellows, office assistants, clinical trial assistants, and research data technicians• Clinical study coordinator and regulatory contact for a multi-center investigator initiated study with 5 sites across the US• Study coordinator for animal drug trials. Duties included ordering drugs, supplies, and animals, coordinating personnel, preparing protocols and amendments• Assisted in protocol and ICF development for investigator initiated clinical trials• Identified and resolved potential protocol, IRB, and regulatory issues • Reviewed and audited source/CRF documents, IRB renewals, and amendment submissions for clinical research coordinators, clinical trials assistants, and research fellows• Interviewed, trained, and mentored new clinical research employees• Prepared regulatory documents, IRB submissions, renewals, and amendments• Recruited and consented subjects• Facilitated study contract and budget negotiations with pharmaceutical companies• Maintained clinical trial financial accounts and managed clinical research billing transactions• Prepared, submitted, and tracked monthly invoices to pharmaceutical sponsors and vendors• Lead weekly meetings with Dermatopharmacology staff• Developed and implemented Dermatopharmacology Research Center SOPs• Planned and organized physician educational meetings (150+ attendees)• Assisted in the design framework and contract development of a national patient registry

• Audited case report forms and source documents in preparation for trial monitors • Prepared regulatory documents and research summaries• Supervised the receipt and dissemination of study related regulatory documents and correspondence from assigned sites• Submitted protocol renewals and amendments to the IRB