Manager Quality

Michelle Salinardi

Alameda, CA

MichelleSalinardi

@gmail

.com

Tel: 415-***-****

Healthcare Manager for 10 years. Operations Manager for 6 years. Effective problem solver that enjoys prioritizing and managing a heavy

workflow with minimal direction. Strong communication and coordination skills and able to make tough decisions. Creative problem solving

and critical thinking skills. Strong relationships across; disciplines, cross fucntional teams, government agencies, and outside venders.

Hardworking and dedicated to completing quality projects on time.

As a manager, I strive to create a productive and collaborative atmosphere where all team members feel their input is valued.

Education

Master's Public Administration 1992

Healthcare Management concentration University of New Haven, CT

Bachelor of Science 1988

Public Health Administration University of New Haven, CT

Work Experience

Consultant: September 2012 present

New Leaf Treatment Center,Lafayette, CA

Provide such services as; survey deveopment, staff training, protocol and contract review, and policy review.

Clinical Research Manager: April 2011 September 2012

University of California, San Francisco, CA

Fucntioned as the manager of clinical trials, clinical research coordinators, and business and financial operations for the Stroke Sceinces

Group (SSG). Responsible for the execution of sponsor and investigator initiated studies. Reviewed and track clinical trial budgets;

coordinated the process for their approval; facilitated logistical issues; assisted in the initial implementation of research projects; worked

with Neurology Department Finance Unit to review all trial financial activity to ensure expenses are appropriate to the project and spending

remained within budget. Oversaw workflow and supervised research coordinators and administrative staff.

Research Program Manager 2004 April 2011

California Pacific Medical Center, San Francisco, CA

Recruited by the Co directors of the Addiction and Pharmacology Rearch Lab (APRL). Responsible for the overall operations of the lab.

Managed a 20 person interdisciplinary research team. Directly supervised up to 15 staff in the administration of investigator initiated and

pharmacuetical sponsored clinical reserach studies. Responsible for staff hiring, promoting, and discplinary actions. Managed budgets,

oversaw regulatory submissions, analyzed and managed all advertising campaigns, facilitated the preparation of new grant applications

and renewals, conducted staff trainings, set priorities and determined staffing levels and workflow, assisted with patient visits and blood

draws.

● Operationalized the start up of the new research lab.

● Created and implemented a Good Clinical Practices (GCP) training for all staff.

● Implemented a New Coordinator training for all new coordinators.

● Increased subject enrollment rates by researching effective recruitment methods.

● Successfully negotiated pharmaceutical contracts and vendor pricing.

Interview Department Manager (Research) 2002 2004

California Birth Defects Monitoring Program, Berkeley, CA

Managed the day to day operations of the Interview Research Department. Trained all new staff on the proper administration of; study

instruments, biologic sample collection, and field interview procedures. Prepared IRB submissions and facilitated meetings with

programming staff, research analysts, data managers, and principle investigators.

● Implemented new strategies that increased subject response rates by 20% to meet sponsor requirements.

● Revised all policies and procedures to streamline work processes and increase efficiency.

Clinical Research Associate (CRA) 1999 2001

University of California (UCLA)

Hired in 1999 to coordinate a study site in the multi center research study below. In 2000 was recruited by the Study Manager to be the

Regional CRA. Responsibilities included; monitoring study sites for protocol and regulatory compliance, educating study sites on quality

control and data management, preparing compliance reports and site monitoring reports.

• Chaired bi weekly national conference call with all study sites and the Coordinating Center.

• Improved relationships between site staff and monitoring staff by approaching training opportunities in a non threatening and

educational way.

Study Coordinator 1999 2000

New Leaf Treatment Center, Lafayette, CA

Coordinated and facilitated the daily clinical trial activities of the study. Recruited and properly consented subjects, accurately completed

CRF's, coordinated subject visits, supervised and trained junior staff, assisted with analyzing data and manuscript preparations.

● Completed the study with the highest number of enrolled subjects, despite being the last of 8 sites to begin enrollment.

● Site leader with a 90% completion rate at one year subject follow ups.

● Significantly improved relations between study staff and clinical staff by fostering a team approach and serving as the study

liaison.

Program Director/Health Science Specialist 1994 1999

Hines VA Hospital, Hines, IL

Administrative director for a day treatment and 20 bed residential dual diagnosis (pyschiatric/substance abuse) program. In the absence of

the Section Chief would serve as his representative in senior management meetings.

● Successfully conducted a study with results that directly lead to the expansion of the day treatment program to include a 20 bed

residential program.

● Redesigned the Dual Diagnosis program and established a structured daily patient schedule which included regular team

treatment planning meetings for all patients.

● Appointed by the Director of the hospital to conduct hospital investigations and serve on special task forces.

● Appointed by the VA Substance Abuse District Committee to train the region on the proper conduct of a new patient evaluation

tool that would be used at the VA on a national level. Achieved the nationally mandated compliance goal.

Clinical Analyst, Quality Management 1993 1994

West Haven VA Hospital, West Haven, CT

Prepared the Psychiatry Department for regulatory reviews. Designed new quality measures for the Psychiatry Department and monitored

and analyzed these outcomes. Reported findings and made recommendations to the Chief of Staff’s office and the Psychiatry department

management team.

● Improved quality measure scores by 30% in 9 months.

● Implemented new quality measures resulting in a decrease in patient recidivism by 20%.

● Successfully prepared the Psychiatry department for their JCAHO review.

Research Coordinator/CNS 1992 1993

West Haven Veteran’s Hospital, West Haven, CT

Psychiatric Technician 1990 1992

Yale University/CT Mental Health Center, New Haven, CT

Pharmacy Technician 1988 1990

St Raphael’s Hospital, New Haven, CT

Additional Skills

● Working knowledge of GCP, ICH guidelines, FDA, DEA, IRB, RAP C, and NIH regulations

● Certified in multiple EDC and IVRS systems

● Certified/licensed California Phlebotomist

● Specialist in CNS and Substance Abuse research

● Extensive work with PTSD Veterans – CAPS, SCID, SADS L, ASI, neuropsych testing

● CPR and First Aide certified

● IATA certified

● Proficient in MS Word, Excel, PowerPoint, Velos eResearch software

● Experienced working with sesitive and confidential information

● Enjoy working with and helping patients

● Team player

Contact this candidate