Carol Murphy Email and Phone Number

• Oversees industry sponsored clinical research revenue and expenditures in partnership with departmental Executive• Administrators, departmental clinical research managers/directors, BSD Finance, and other key stakeholders.• Provide leadership and oversight in the execution and negotiation of clinical trials budgets, master clinical trial rate cards and pricing agreements, and other related agreements.• Oversee the development and adoption of clinical research financial policies and procedures across the division.• Serves as a point of contact for clinical trial budgeting, financial management, and compliance. Acts as a key resource for clinical trial financial management across the division.• Oversees clinical research budget planning in partnership with departments and service lines and BSD finance.• Act as business owner in the development of software and technology solutions to enhance the support of clinical trial finance; design and oversee training on new finance systems for clinical research finance.• Responsible for the creation and delivery of education and training to support the professional development and quality of work for clinical research budgeting and financial management staff across departments and units.• In partnership with the Assistant Dean and Dean for Clinical Research, develops long- and short-term plans to achieve financial goals, business strategies/plans, and financial forecasts/models for the clinical research enterprise.• Manages employee(s) through direct and indirect reporting relationships. Supports clinical trial financial management workforce planning, training, assessment, and succession.• Develops and implements scalable systems, processes, and analytics to measure and constantly improve clinical research financial operations.• Implement best practices to ensure that the management of all clinical trial and program support accounts are in compliance.

 Develop clinical study protocols & case report forms, identify, assess, and select clinical trial sites and coordinate appropriate monitoring of live study phases. Provide regulatory support of live phases of clinical research projects to confirm compliance with the study protocol to ensure that the data generated are accurate, consistent, and complete. Liaise with other customers contracted to perform clinical studies, ensuring appropriate approvals are gained and procedures followed. Utilize clinical systems (CTMS, eTMF, EDC) to ensure all trials within responsibility are delivered against agreed project milestones and to expected quality. Develop, negotiate, and defend budgets, create MCA using budget, ICF, IB to determine study overall feasibility.  Act as Protocol Lead on one or more clinical trials and serving as the main point of contact for clinical site management and clinical trial site monitoring functions. Assist with the design and review of new clinical trial protocols, informed consent, CRFs, Statistical Analysis Plan, and Clinical Study Report in collaboration with medical monitor, biostatistician, regulatory affairs, senior management and other relevant groups.  Create and maintain clinical trial start-up documents such as the Clinical Monitoring Plan, CRF Completion Guidelines and other plans and processes as appropriate. Provide support to Field Clinical Research Associates (CRAs) and assist in the initiating, monitoring and coordinating day-to-day operations of clinical trial sites. Conducting monitoring visits including pre study, initiation, interim monitoring and close visits as needed.

 Developed, executed, and oversaw a very successful, a $1.5M and growing clinical research organization across a 10 hospital system.  Developed all budgets, negotiated contracts, created Medicare analyses, invoiced, and reconciled all studies.  Increased revenue by actively participating in the recruitment of new investigators and identification of new business opportunities.  Functioned as a research coordinator, in addition to other roles, until able to hire. Wrote and implemented all regulatory policies and procedures.  In-depth experience with site selection/recruitment/activation, risk assessments, quality and data integrity reviews.  Conducted routine regulatory audits across the health system on a quarterly schedule.  Collaborated with Executive level management throughout the system to achieve strategic outcomes, increase market presence, and develop/maintain research policy and procedure.  Directed, organized, and executed activities related to industry-sponsored studies, cooperative group trials, and research education for nursing, pharmacists, and physicians.  Oversaw the dissemination of research findings via publications and presentations throughout the system.

Launched ZymoGenetics' first commercial product used in general surgery, Recombinant Human Thrombin. Developed and presented extensive medical education programs for physicians, hospital pharmacists, group purchasing organizations, and executive management of stand-alone hospitals or health system representatives. Participated in active clinical research via trial site recruiting, study startup thru closure. Collaborated closely with physicians, CRAs, Study-level monitors, and Executive Administrators were key to enrollment success.

Served in leadership role in the startup of Next Wave Pharmaceuticals. Wrote all training material and conducted all staff training on proprietary iron pediatric iron product. Collaborated with clinical trials and regulatory affairs for pending FDA approval of pipeline products. Obtained 35% increase in market in year 1; leading sales district.

Strong clinical background associated with clotting factors was used to provide hematologist’s/endocrinologist’s with scientific, evidence-based data for patients suffering from hemophilia and growth disorders. Successfully recruited/supported key physicians and study sites for on-going clinical trials in organ transplant, burn, neurosurgery, and trauma. Worked closely with Executive Leadership to develop new business tools by identifying Key Opinion Leaders interested in participating in on-going clinical research. Developed/maintained KOL’s, trained commercial speakers, assisted with product pull-through in collaboration with commercial team management, and developed/presented educational programs internally and externally. Attended scientific/medical/professional meetings for educational purposes and provided scientific support as needed.

Created and implemented unique decile targeting programs led to becoming the top region in the country and revenue increased $1.4M over four years. Regional management role targeting hematology, oncology and endocrinology clinicians, responsible for the development and maintenance of solid customer relationships with key opinion leaders. Tracked and measured sales effectiveness via strategic and tactical applications at the regional level. Leadership and coaching style focused on individual strengths, product and disease state knowledge.Product: Recombinant human FVIIa/Growth Hormone Therapeutics: Hematology/Endocrinology

Diabetes products. Ranked as a top 10 salesperson in the country for two years.

Identified NEW revenue source by working closely with state regulatory bodies, hospitals, and long-term medical care facilities to place medically-fragile and emotionally-behaviorally disturbed children in foster homes. Increased organizational revenue by $1.2M. Identified, hired, and trained 6 nurses responsible for the education of foster parents on a variety of disease states and mechanical life support devices. Wrote and published an instructional book on caring for medically and emotionally disturbed children in foster homes. Author – Medically-fragile Child Care in the Foster Home

Experience in care includes IV medications, central/art lines, vents, oxygen, BIPAP/CPAP/VPAP, blood draws (stick and lines), tube feedings

Staff Nurse: Organ Transplant