Cory Dauphin Email & Phone Number

Germantown, Md

- Oversee Cross-Functional Teams and External Providers: Managed cross-functional team resources and external service providers to conduct trials for the UltraCAR-T and AdenoVerse platforms, ensuring seamless collaboration and execution.- Vendor and CRO Management: Led the selection and management of Contract Research Organizations (CROs) and other external vendors, fostering strong partnerships to support trial objectives.- Budget Oversight: Directed budget development and oversight for Phase 1 & 2 clinical trials, managing over $20 million to ensure financial compliance and efficiency.- Document Authorship and Review: Assisted in the authorship and review of critical trial documents, including scope definition documents, pharmacy manuals, lab manuals, informed consents, advertisements, project plans, Case Report Forms (CRFs), and regulatory submissions.- Progress and Performance Monitoring: Proactively monitored trial progress, providing weekly reports to management on performance, timelines, challenges, and financial metrics to ensure transparency and accountability.- Clinical Operations Expertise: Contributed clinical operations expertise in cross-functional meetings, working closely with team members to ensure alignment and support across departments.- Leadership and Mentorship: Managed and mentored Clinical Trial Managers, ensuring program execution according to Standard Operating Procedures (SOPs), project plans, and International Conference on Harmonisation (ICH) guidelines.

Germantown, Maryland, United States

- Managed Precigen’s Clinical Operations team and external service providers (including CROs, Lab Vendors, and consultants) to conduct clinical trials across the CAR-T platform.- Identified external vendors and facilitated all RFPs, BDs, and final vendor selection, as well as contract and budget negotiations.- Monitored, analyzed and projected study costs, personnel hours, timelines, and project needs.- Worked collaboratively with internal groups including CMC, QA, Regulatory, Translational Research, and Project Management to develop plans and drive clinical activities to support corporate goals.- Actively managed the coordination of clinical and manufacturing activities to support our trial sites and patients.- Managed external relationships critical to the success of clinical programs including investigational sites, key opinion leaders and external partners.- Developed a logistics pathway involving manufacturing, QA, and project management to facilitate a new product delivery method.- Trained and developed new team members in the Clinical Operations division.

Washington Dc-Baltimore Area

- Oversaw internal resources and external service providers (including medical monitoring, safety, data management, auditors, andconsultants) to conduct trials on time, on budget, and in compliance with regulations and SOPs.- Developed and maintained tracking tools for clinical trials including site status, enrollment, monitoring visits, and sample tracking.- Supported development of study related documents including site feasibility, informed consent documents, monitoring plans, regulatoryand start-up plans, patient recruitment plans, pharmacy and lab manuals, and training materials.- Drove study start up in collaboration with internal and external project teams including budget and contract negotiations, IRB/ECsubmissions and response and facilitation of essential document collection.- Identified issues and implemented corrective actions to ensure quick resolution of deviations or quality issues.

Washington, District Of Columbia, United States

– Manage a clinical operations team of Clinical Trial Specialists, Central Monitoring Associates, and Clinical Research Associates – Serve as primary project contact for all clinical issues for clients, vendors, and internal functional areas – Set, track, and review milestones, tasks, timelines and projected hours for all clinical activities for assigned projects to ensure adherence to contracts and budgets– Supervise team to ensure all clinical tasks meet internal and client expectations– Participate in requests for proposals, bid defenses, and other business development activities – Liaise with Clinical Operations Managers to resolve resource and performance issues– Identify and resolve complex clinical issues for research projects– Develop and create materials for both internal team training and external site training– Design and successfully execute study plans– Collaborate with medical monitors to ensure proper capture and coding of protocol deviations

Washington D.C. Metro Area

– Monitored clinical trials to ensure sponsor and investigator obligations were met and studies were compliant with applicable local regulatory requirements and ICH-GCP guidelines– Performed qualification, initiation, monitoring, and close out visits to investigative sites– Conducted motivational visits to investigational sites to encourage new recruitment initiatives for rare disease studies– Reviewed, evaluated, and verified accuracy of clinical trial data collected– Accurately recorded monitoring activity and other essential recordation required by SOPs or other contractual obligations– Evaluated site and trial related issues to elevate issues as necessary, and collaborated with site, internal team and client to develop corrective solutions– Performed source document verification and query resolution– Assessed IP accountability, dispensation, and compliance at investigative sites– Verified Serious Adverse Event (SAE) reporting according to trial specifications and ICH-GCP guidelines– Acted as primary point of contact for investigative sites– Facilitated site audits and audit resolution– Served as observation visit leader and performance visit leader for new hires– Mentored junior level CRAs and new employees

Washington D.C. Metro Area

– Monitored clinical trials to ensure sponsor and investigator obligations were met and studies were compliant with applicable local regulatory requirements and ICH-GCP guidelines– Performed qualification, initiation, monitoring, and close out visits to investigative sites– Conducted motivational visits to investigational sites to encourage new recruitment initiatives for rare disease studies– Reviewed, evaluated, and verified accuracy of clinical trial data collected– Accurately recorded monitoring activity and other essential recordation required by SOPs or other contractual obligations– Evaluated site and trial related issues to elevate issues as necessary, and collaborated with site, internal team and client to develop corrective solutions– Performed source document verification and query resolution– Assessed IP accountability, dispensation, and compliance at investigative sites– Verified Serious Adverse Event (SAE) reporting according to trial specifications and ICH-GCP guidelines– Acted as primary point of contact for investigative sites– Facilitated site audits and audit resolution

Washington, Dc - Decentralized

– Monitored Phase II and III clinical trials in dermatology, gastroenterology, immunology and rheumatology – Performed qualification, initiation, monitoring, and close out visits to investigative sites– Reviewed, evaluated, and verified accuracy of clinical trial data collected– Accurately communicated regular site status information to team members, trial management, and updated trial management tools– Monitored IP accountability and compliance in both blinded and unblinded roles

Syracuse, Ny

– Monitored clinical trials as a part of the Northeast ALS Consortium’s Monitoring and Outcomes center, working on both Industry-Sponsored and Investigator-Initiated drug and device studies for Amyotrophic Lateral Sclerosis – Developed monitoring plans and trip report templates– Designed the EDC’s Case Report Forms and system logic checks in coordination with data management group– Conducted qualification, initiation, monitoring, and close out visits to investigative sites– Created and implemented the monitoring group’s first Remote Monitoring Plan– Created site facing training materials and source document templates

Syracuse, Ny

- Collected blood specimens from patients by venipuncture and micro-sampling technique for thepurpose of clinical laboratory testing- Collaborated with a wide range of departments and healthcare providers to coordinate the timing andcollection of diagnostic tests in conjunction with the patient's care plan and status- Conducted electrocardiogram testing on patients

Syracuse, New York Area

– Collected units of blood from donors for the purpose of blood product manufacturing– Assessed donor eligibility by conducting a health history interview, evaluating vital signs, and testing hemoglobin