Curriculum Vitae

• Accountable for regional core operational team and global regional heads, their activities, and liaised with project leadership, client, and project vendors.

• Responsible for management of the Clinical Operations teams, quality, and compliance with project plans, successfully meeting project deliverables.

• Responsible for ensuring clinical operations activities were within budget and scope.-Managed and monitored weekly data management analysis and distribution.

• Managed, organized, and maintained clinical monitoring plans and tracking tools, developed study tools for site personnel.

• Performed CRA trainings, trip report reviews, and resourcing.

• Managed and monitored project vendors for quality/issues, managed vendor contracts.

• Monitored clinical investigative sites and personnel across multiple indications and protocols.

• Conducted site visits to monitor for subject safety, ICH/GCP compliance, investigator quality, data integrity, and protocol adherence.

• Administered project related training to clinical sites.

• Provided mentorship and support for new CRAs.-Assisted colleagues with the monitoring of difficult sites.

<2006>

Lead Clinical Trial Coordinator

Baxter Healthcare at Scripps Green Hospital

Interventional Cardiology

Role Responsibilities

• Managed and wrote the preparation of all IRB and regulatory submissions.

• Trained site personnel on fundamental Clinical Trial processes and procedures in accordance with FDA CFR Title 21 and ICH/GCP guidelines.

• Trained site personnel on IRB process, procedures, and submission requirements.

• Performed internal audit of all study documents and subject source/data.

• Performed internal audit of cell acquisition and processing for subject procedures.

• Managed and trained site staff on clinical and regulatory procedures.

• Screened, enrolled, and followed study patients throughout the course of clinical trials.

• Managed IRB reporting of onsite and offsite SAEs/safety reports.

2004 - 2006

Asst. Program Manager, Clinical Trial Coordinator

University of California San Diego (UCSD) Medical Center

Neuropsychiatry & Behavioral Medicine

Role Responsibilities

• Performed internal assessments/site audits and monitor active clinical research studies.

• Ensured site is protocol and GCP/ICH compliant.-Confirmed site staff was trained on clinical and regulatory procedures, training is properly documented and continued.

• Monitored financial reports, assess spending budgets, and coordinate research contracts.

• Coordinated administrative, management, and staffing activities.

• Developed and revised research policies and site Specific standard operating procedures.

• Managed and coordinated multiple protocols from study start.

• UP to study closeout-Managed site recruitment and retention plans.

• Performed final site review of Case Report Forms.

• Managed and oversaw the preparation of IRB project applications and regulatory submissions.

• Managed IRB reporting of onsite and offsite SAEs/safety reports.

• Screened patients, performed clinical evaluations, administered psychiatric diagnostic and rating scales.

2002 - 2004

Clinical Research Coordinator, Research Assistant

UCSD Medical Center at VA Health Systems, Bioethics/Geropsychiatry

Rady's Children's Hospital, Children Services Research

Role Responsibilities

• Coordinated and supported academic and clinical Principal Investigators on research protocols, IRB ethics submissions, data collection, and publication presentation.

• Provided administrative and analytical support  across multiple departments, including psychiatry, bioethics, and pediatric services.