Managed IRB vendor selection process; edited SOPs; supervised 2 IRB Associates; maintained federal IRB registration; created a single IRB panel from two existing panels to be in compliance with federal regulations and AAHRP standards; oversaw transfer of research programs to external IRBs

Managed all administrative functions for the IRB. Prepared and maintain SOPs.Successfully underwent an FDA audit with no 483 issued.Assisted with SOP and Work Instruction development for all of ACR Clinical Research Center.Tracked ACR CRC SOPs and WIs for biennial review requirments.Developed and maintained training curriculum matrices for all ACR CRC departments and functional areas.Assisted QA Director as required (audit and CAPA prep and follow-up; document retention maintenance)

Co-managed a late-phase, global clinical trial in infectious disease (secondarily infected wounds) for a major pharma company. Updated and maintained Project Plan. Participated in the development of a generic eDC system for registry studies, including final UAT testing

Assisted with review and consolidation of Ovation Clinical Research and ICON SOPs. Prepared IRB submission guidelines for late phase studies. Researched European submission requirements / regulations for post-approval, non-interventional observational studies in different European countries [specifically Germany and Spain].

Conducted routine monitoring visits for 3 Phase II/III GI studies in Irritable Bowel & Chron's Disease.

Coordinated Aspire IRB’s acquisition of St. Davids HRRB; consolidated SOPs of the two IRBs; redesigned submission forms and notification letters; continued to manage IRB office functions for the new East Coast office

Increased the IRB meeting schedule from monthly to weekly; developed submission tracking system which was used for creation of all meeting agendas and minutes, protocol activity reports, and reminder notices; maintained a less than one week turn-around time from meeting to notification of investigators; updated SOPs in response to federal guidance documents; interacted with study sponsors (CROs, pharmaceutical, biotech and devise companies), investigators and study coordinators; assisted in the identification and appointment of one scientific board member; represented St. Davids HRRB at industry conferences (DIA, ACRP, SoCRA, Partnerships with CROs).

Directed the Proposals & Contracts staff in preparing proposals, budgets, contracts, amendments and proposal presentations; represented Covance Periapproval Services at client meetings, conference and seminar exhibits, industry trade shows and other external business development functions; acted as liaison between Proposals & Contracts staff, sales staff and operational staff.

Managed target accounts in California; collected and analyzed pertinent information regarding accounts, i.e., pipeline and organizational structure; responded to initial client RFIs; identified and assessed client needs; prepared proposals, budgets, contracts, amendments and proposal presentations; represented Covance Periapproval Services at client meetings, conference and seminar exhibits, industry trade shows and other external business development functions; supervised internal department staff; oversaw development and implementation of new proposal development process and pricing modules.

Prepared proposals, budgets, contracts, amendments and proposal presentations; conducted feasibility studies; prepared monthly reports of business development activities; maintained records of Corning PACT experience and capabilities; supervised three personnel (proposal administrator, technical assistant, secretary).

Managed clinical trials in various therapeutic areas, including the Rifabutin Treatment IND study for the prophylaxis of MAC in AIDS patients; communicated with AIDS advocate groups; supervised two Assistant PMs and ten CRAs; developed study materials; maintained and forecast study budgets; developed and maintained quality practices; prepared financial and project status reports.

Acted as team leader in large Phase IIIb antihypertensive study; managed site selection activities including determination of site feasibility; coordinated monitoring schedules; tracked study progress, patient enrollment, study payments; assisted in maintenance of study budget; acted as liaison with subcontractors in development of study kit, CRFs and instructional video; interacted with Data Management department in preparing monthly and final reports.

Maintained a 10 site, 400-subject Phase III Cystoid Macular Edema study; monitored (interim visits) five sites; tracked study progress, patient enrollment, study payments (investigator and vendor).

Maintained a 20 site, 200-subject CHF study. Tracked study progress, subject enrollment, study payments. Managed study data / queries. Also worked on Phase II & III studies in cardiovascular, renal, gastrointestinal, gynecological, and orthopedic areas.