Deb Mitchell Email & Phone Number

Wilmington, Nc, Us

Leads, executes and achieves site activation and amendment deliverables within a region or globally within the assigned projects, by managing the scope of work to timelines, costs and quality. Ensures all project deliverables meet contracted and customers expectations, providing accurate projections, reports and updates, as well as ongoing risk assessments. Develops and maintains strategic relationships with customers in alignment with assigned projects, ensuring individual project targets are met and services are provided with the highest quality standards. Serves as the primary startup contact for the Project Lead and client.

Research Triangle Park, Nc, Us

Research Triangle Park, Nc, Us

I am currently a Site Activation Manager/Regulatory and Start-Up Lead managing the delivery of all required start-up and regulatory activities in accordance with GCP/ICH guidelines for selected studies within the US and Canada.• Oversee the execution of Start Up for assigned projects in accordance with the agreed Regulatory Start Up strategy. • Provide overall guidance and oversight of multi-site projects during initial start-up and maintenance phase as an integral member of the study management team. • Determine regulatory strategy/expectations and parameters for submissions and all necessary authorizations; identify regulatory complexity and challenges and offer creative and practical solutions to support execution of the Start Up plan. • Ensure accurate completion and maintenance of internal systems (with emphasis on CTMS), databases, tracking tools, timelines and project plans with project specific information. • Ensure overall project efficiency and adherence to project timelines and financial goals; report performance metrics and out of scope activities as required. • Manage start-up team to meet expected deliverables and timelines.

• Provide Line management responsibilities for designated clinical trial assistants • Allocation of resources to awarded and ongoing projects • Participate in HR hiring process including review of potential candidates and interviewing process • Ensure that staff are meeting defined workload and quality metrics through regular review and reporting of findings as outlined by clinical operations management • Mentor and train clinical staff individually or project teams.

Durham, North Carolina, Us

• Worked on Phase I-IV studies• Application of functional base of knowledge regarding the application of GCPs, ICH guidelines, applicable regulatory requirements and SOPs and Work Instructions to assigned responsibilities.• Assist Clinical Project Manager (CPM) and Clinical Research Associates (CRAs) with accurately updating and maintaining clinical systems that track site compliance and performance within project timelines.• Collaborate with clinical team on the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures. Assist with periodic review of study files for accuracy and completeness.• Collaborate with clinical team on the preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.• Mentoring/Training clinical staff individually or project teams

Durham, North Carolina, Us

Regulatory/Site Start Up Lead• Worked on over 50 protocols for multiple sponsors• Prepare contract and budget amendment templates for the team• Review and negotiate contract and budget amendments with the investigational sites/institutions• Collaborated with the legal department for complex mattersRegulatory/Site Start Up Specialist• Worked on Phase I-IV studies• Review and/or negotiate regulatory documents, and contracts and budgets as required for site initiation, contact sites as required to resolve issues, and determine completeness and readiness for Clinical Supplies/Investigational Product shipment.• Manage data tracking entries into designated clinical tracking systems in accordance with project requirements.• Assist designated team members in preparing submissions for Independent Ethics Committees (IEC) or Institutional Review Boards (IRB), by compiling the package of documents for the IEC/IRB and forwarding it to either the Investigator or IEC/IRB as directed.• Application of functional base of knowledge regarding the application of GCPs, ICH guidelines, applicable regulatory requirements and Quintiles and Sponsor SOPs and Work Instructions to assigned responsibilities.• Quality Assurance Testing/Training on new computer systems

• Worked as a study coordinator on various Phase II-IV studies.• Completed essential regulatory documents• Completed all local IRB submissions for new protocols, amendments, SAE’s and annual reviews• Responsible for completion of CRF’s and inputting the data in the Inform and PDS systems• Performed all study specific ophthalmic testing, including patient history, visual acuity, manual refractions, application tonometry, visual fields, OCT, fluorescein angiograms and fundus photography.

Kansas City, Mo, Us

• Performed all ophthalmic tests including, patient history, visual acuity, manual refractions, application tonometry, visual fields, OCT, GDX, fluorescein angiograms, fundus photography, A-scans, B-scans and scribing.• Counseled patient’s for all ophthalmic surgeries • Trained new technicians in all aspects of the office