Summary
Overview
Work History
Education
Skills
Qualifications Summary
Affiliations
Education Credentials
Professional References
Professional Highlights
Timeline
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Adrianne Silverman

Vail,AZ

Summary

Multi-faceted professional with extensive experience in clinical operations, business management, operations management, and strategic planning. Decisive leader with proven success in maximizing revenue, increasing satisfaction, and identifying growth opportunities. Adept in performing within dynamically changing environments requiring focused decision-making.

Clinical research professional prepared to leverage extensive background in managing clinical trials and research operations. Adept at ensuring compliance with regulatory standards and enhancing study efficiency. Known for fostering collaborative team environments and flexibly adapting to changing needs. Skilled in patient management and protocol development.

Overview

9
9
years of professional experience

Work History

Sr. Clinical Research Coordinator

Arizona Liver Health
03.2020 - Current
  • Ensured compliance with regulatory requirements by conducting thorough audits of study documents and procedures.
  • Mange Multiple protocols with different disease states
  • Assisted in the preparation of scientific manuscripts based on clinical trial findings for publication in peer-reviewed journals.
  • Improved patient recruitment by developing and implementing targeted outreach strategies.
  • Streamlined study processes for increased efficiency by collaborating with cross-functional teams on protocol development and implementation.
  • Increased patient retention rates by establishing strong relationships with participants through effective communication and followup.
  • Contributed to the successful completion of numerous studies by coordinating all aspects of trial initiation, execution, and close-out activities.
  • Facilitated clinical trial progression, effectively managing multiple projects simultaneously.
  • Optimized patient safety during clinical trials by diligently monitoring adverse events and promptly escalating concerns when necessary.
  • Developed robust data management plans for efficient data capture, analysis, and reporting throughout the study lifecycle.
  • Collaborated with investigators to develop innovative clinical trial designs, optimizing data collection methods for better results.
  • Coordinated with other departments such as biostatistics and regulatory affairs to streamline processes and ensure successful project completion.
  • Fostered a positive working environment for research staff through regular team-building activities and ongoing professional development opportunities.
  • Served as a liaison between site personnel, investigators, and sponsors to ensure clear communication throughout the trial process.
  • Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
  • Collaborated with clinical staff and other healthcare professionals to support clinical trial data accuracy.
  • Coordinated and monitored clinical trial activities to support timely and accurate completion of studies.
  • Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
  • Followed informed consent processes and maintained records.
  • Gathered, processed, and shipped lab specimens.
  • Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
  • Managed patient recruitment, informed consent process and data entry to support trial objectives.
  • Participated in initiation visits and investigator meetings, implementing trials following study timelines and budgets.
  • Maintained compliance with protocols covering patient care and clinical trial operations.
  • Collected data and followed research protocols, operations manuals, and case report form requirements.
  • Monitored patient safety throughout clinical trials and reported any adverse events.
  • Maintained accurate and up-to-date case report forms and source documents for traceability.
  • Developed and maintained accurate and up-to-date case report forms and source documents.
  • Prepared and maintained regulatory documents for clinical trial submissions.

In House Operations and Study Protocol Project Manager

ARIZON CLINICAL RESEARCH CENTER
02.2016 - 02.2020
  • Utilization of universal precautions in clinical research
  • Obtain and maintain certification for the handling of potential infectious fluids and maintains safety for self, patient and others around them; familiar with all current and active protocols, case report forms, informed consent process, and creation of source documentation
  • Adhere to GCP, ICH, HIPAA, NIH, FDA, IATA training and regulations, SOPs and regulatory procedures
  • Manage and maintain onsite research protocol activities and assist off site staff to ensure study protocol procedures and good clinical practices are adhered to
  • Manage and participate in study recruitment and patient screening to ensure enrollment goals are met
  • Direct and guide research assistant on study specific tasks; perform lab procedures, such as: blood specimen collection, centrifuge operation, storing and shipping of lab specimens, accountability of specimens and notification of courier for specimen pick-up
  • Maintain strict confidentiality of patients, manage employees and company information at all times and adhere to HIPAA Guidelines
  • Manage in house day to day operations, staffing, scheduling, medical records, tumor block requisitions, CT scan reports, and ECRF and study specific portal data management for multiple protocols and databases
  • Assist with and complete study start up procedures and regulatory guidelines

Education

Master of Business Administration -

University of Phoenix
Tucson, AZ
01.2010

Bachelor of Science - Business Management

University of Phoenix
Tucson, AZ
01.2008

Nursing Assistant/Patient Care Technician II - Medical

Pima Community College Direct Work Training Program
Tucson, AZ
01.2002

Skills

  • Microsoft Office
  • Crio electronic source
  • Multiple EDC platform
  • Multiple IWRS/IVRS systems
  • Lab portal systems
  • Study specific imaging platforms
  • IRB portals
  • IATA
  • GCP
  • C-SSRS

Qualifications Summary

Multi-faceted professional with extensive experience in clinical operations, business management, operations management, and strategic planning. Decisive leader with proven success in maximizing revenue, increasing satisfaction, and identifying growth opportunities. Adept in performing within dynamically changing environments requiring focused decision-making., Operations Management, Team Building, Change Management, Budget Management, Data Analysis, Data Management, Innovative Leadership, Strategy Development, Clinical Operations, Process Improvement, Research & Analysis, Clinical Research, Staff Supervision, Business Operations, Business Development, Cost Containment, Healthcare Management, Project Management

Affiliations

  • Healthcare Intelligence Network
  • AHCAP

Education Credentials

  • Master of Business Administration, 2010, University of Phoenix, Tucson, AZ
  • Bachelor of Science in Business Management, 2008, University of Phoenix, Tucson, AZ
  • Nursing Assistant/Patient Care Technician II, 2002, Pima Community College Direct Work Training Program, Carondelet St. Joseph’s Hospital

Professional References

  • Cathy Pensak, 520-971-1262, cpensak@ipcm.com
  • Dr. Sohelia Nouri, 520-991-8427, snouri@ipc-hub.com
  • Niki Putzar Davis ACNP, 520-780-2356, npdavis@ipc-hub.com
  • Leslie Ledbetter DNP, 520-750-3256, lledbetter@ipc-hub.com
  • Susy Bravo-Operations Manager, 520-971-1146, ssbravo@ipcm.com
  • Diane Dail LPN, 520-551-0388, ddail@ipcm.com
  • Kim Schneider MA, 520-396-0739, kschneider@ipcm.com

Professional Highlights

  • Charged with accountability for community education and awareness of IPC services and infrastructure.
  • Oversaw all aspects of program development for continuity of patient care and cost reduction for hospitals, skilled nursing facilities, payer sources, and patients.
  • Pioneered the launch of new services in rural underserved areas requiring provider patient care.
  • Established collaborative partnerships with local and regional area hospital systems that developed transitional care programs for the community.
  • Spearheaded re-admission reduction program creation and management for IPC population.

Timeline

Sr. Clinical Research Coordinator

Arizona Liver Health
03.2020 - Current

In House Operations and Study Protocol Project Manager

ARIZON CLINICAL RESEARCH CENTER
02.2016 - 02.2020

Master of Business Administration -

University of Phoenix

Bachelor of Science - Business Management

University of Phoenix

Nursing Assistant/Patient Care Technician II - Medical

Pima Community College Direct Work Training Program
Adrianne Silverman