Summit Clinical Research is an Integrated Research Organization which brings together experienced research sites with proven successes in the Non-Alcoholic Steatohepatitis (NASH) research space. Our mission is to execute comprehensive site recruitment and engagement strategy to efficiently and cost-effectively achieve the target patient enrollment goal, in the projected timelines.

Lead day-to-day operations of two Clinical Research clinical sites conducting Phase 1 through Phase 4 studies in the therapeutic areas of hepatology and gastroenterology with a heavy emphasis on NASH and NAFL-D. Oversee team of ~70 staff (management and associates) across both sites. Supervise direct reports including departmental leads and staff reporting to departmental leads: Clinical Research Coordinating Team, Laboratory, Pharmacy, Sub-Investigators, Recruiters, Clinical Registry, Front Desk/Check Out, Regulatory, QC, Phase 1 Team•Oversight of FDA/Sponsor Audit preparedness and oversight of audits •Liaise with/report study specific information to Sponsors/CROs•Manage third-party vendor relationships•Establish plans and implement timelines for projects to include EDC cleanup, new CTMS, site relocation, realignment of departments, other special projects as they develop•Manage through the life of studies: Study selection/Start-up/Maintenance/Close-out•Attend and schedule PSVs, SIVs, IMVs, COVs•Completion of Study Specific documents •Feasibility and Bid Request management •Lead team meetings, All-Staff meetings•Development and/or refinement of Work Instructions and Site SOPs•Compile reporting for monthly presentations to the Board of Directors •Co-chair of the Events Committee, establishing internal and giving/community-driven events

Led, developed, and supported regional and multi-institutional collaborative investigator-initiated research in emergency medicine, trauma resuscitation, and tactical combat casualty care (TCCC) through the lifecycle: proposal development, submission, award, study execution, analysis, and publication in peer-reviewed literature. Liaised and collaborated with local, regional, and national funding agencies, investigators, and study teams, including military and civilian institutions. Conducted all aspects of Sponsor correspondence for annual Emergency Healthcare Systems Conference.•Solely responsible for quarterly, yearly, and end of grant reporting to Department of Defense•Develop and implement innovative research protocols under the RemTORN project•IRB and ORP HRPO submissions and correspondence•Collaborate with investigators to prepare RFIs, grant/funding applications, abstracts, and publications •Budget review and planning •Plan and conduct Clinical Roundtable Discussion •Medical record review, redaction, and summarization for discussion at Clinical Roundtable•Manage direct reports•Conference Planning, Vendor/Sponsor Conference communication and placement •Attend and represent STRAC/RemTORN at military, EMS, and emergency preparedness conferences as well as staff STRAC/RemTORN booths at military, EMS, and emergency preparedness conferences.

•Coordinate and oversee all functions of the Clinical Research Operational Review (CROR) for the Office of Research Administration•Read, review, and assess every prospective research protocol for operational impact to Seton•Act as liaison between research sites and Seton's operational departments in order to evaluate needs and facilitate research at Seton•Support quality communication between Seton’s Office of Research Administration and our clients (research sites/ teams) regarding proposed and active research studies•Manage direct reports, including: interviewing, assessing, hiring, training, scheduling, appraisals, and disciplinary actions•Manage the work of project teams within constraints of budget and resources•Develop time lines, assign responsibilities, and monitor and summarize progress of all research studies submitted to the CROR•Reinvented the Clinical Research Operational Review and Feasibility processes, effectively reducing turn-around timelines (TATs) for both •Manage changes to CROR and Feasibility processes; ensuring progress continues to be felt by both Seton’s Office of Research Administration and our clients•Prepare reports for Seton leadership regarding the CROR and Feasibility status of all projects throughout the Seton research network •Use knowledge of hospital administration, Seton's operational departments, human subject protection, human subject research, clinical budgets, and IRBs to manage over 400 active Research protocols at Seton•Assist in the determination of clinical research contracting needs•Work in compliance with all human subject protection regulations and guidance•Develop policies and procedures for the Clinical Research Operational Review and Feasibility processes at the hospital and systems levels

•Provided day-to-day administrative support to the team•Trained and mentored new Project Assistants •Corresponded with investigators, team members, and sponsors on various project related issues•Maintained central study files for assigned projects•Conducted detailed audits of study files•Tracked confidential study data in the PPD Siebel database •Developed, processed, and reviewed Crystal reports from the PPD Siebel database•Reviewed and transmitted regulatory documents to the IRB and study sponsor•Prepared agendas, attended, created detailed minutes for study-specific internal and sponsor meetings•Reviewed, processed, and rolled up payments to sites

•Performed quality control audits•Provided filing support for multiple studies •Ensured file room security and confidentiality•Trained and mentored new Records Management staff•Served as a department lead for implementation of a new records management database, including maintenance and repair•Promoted to Sr. Position after 1 year

•Interviewed and hired new staff •Trained, developed, scheduled, supervised, and evaluated staff•Coordinated on site parties and events •Managed food, alcohol, labor costs, and quality of service/ product•Headed customer, vendor, and client relations•Completed inventory control and placed product orders•Directed employee closing and opening shifts•Administered staff check-out and end-of-day reports/ finance balancing

•Staffed, trained, scheduled, and evaluated staff•Managed food and labor costs•Completed inventory control and placed product orders•Produced product (ice cream, gelato, sorbet)•Administered staff check-out and end-of-day reports/ finance balancing

•Coordinated and trained volunteers during tri-annual Pledge Drive •Entered data, ran scripts, programmed incentives during Pledge Drive•Acted as Receptionist and held other administrative duties during non-Pledge Drive months

•Acted as Receptionist and held other administrative duties •Entered data and completed filing for the office•Researched and revised statutes requiring updates

•Customer satisfaction and front-of-house needs•Production of product (ice cream, gelato, sorbet)•Promoted to manager