Pamela Gonzalez Email & Phone Number

Chicago, Il, Us

Chicago, Illinois, United States

As a Huron Higher Education Clinical Research consultant, I partner with clients to provide solutions to address the declining resources and increasing regulatory requirements to customize innovative operating models that improve the efficiency and effectiveness of the research enterprise will be critical to an institution’s future success. Using a team model with deep expertise, I help organizations shape their research strategy, enhance research operations, manage risk and optimize technologies to guide them in transforming their research enterprise. We enable organizations to align their research portfolio with their overarching strategy to drive resources to areas with the greatest impact on the institution - and on society.

Greater Chicago Area

Responsibilities:• Support clinical research infrastructure across the division to grow research portfolio and provide patients access to Clinical Trials• Oversee Regulatory, Operations and Conduct, Research Finance and Core Office of Clinical Research service lines• Lead strategic planning for research, including goal setting, metric development, quality tolerance limits and risk mitigation

Greater Chicago Area

Hines Cooperative Studies Regional Quality Assurance Specialist for Clinical Research• Analyze regulatory, accreditation, and quality standards to assess Cooperative Study's compliance.• Develop and execute project plans, policies, and documentation standards,• Chair committees and serve as subject matter expert to implement ISO 9001:2015; and regulatory/accreditation standards, including FDA, DEA, VA EPA, OSHA and GCP. • Design and deliver training to support quality management activities to ensure regulatory compliance.

Greater Chicago Area

Oversee talented team to ensure that employers and members experience a high touch with every encounter as they create a culture of wellness. Provide infrastructure oversight to ensure that EngagementHealth® delivers on its clients needs and exceed customer expectations. • Lead and develop EngagementHealth’s team of Account Managers to deliver all highly effective wellness programs that achieve a high level of quality and client satisfaction. This teammanages and implements all aspects of the EngagementHealth wellness programs including planning, communication, implementation and administration.• Participate in the preparation of department budgets and monitor department expenses to ensure that financial goals are met.• Establish, monitor and enforce policies, procedure and internal controls to ensure consistent operations and comply with HIPAA and other applicable laws and regulations.• Report to Senior Management regularly regarding operations, client program status, and problem solve to enhance the member experience/client experience.• Stay current on industry trends, practices and standards in order to participate in the design and development of wellness-related products and programs.

Actively monitors health quality and practice information and data; analyzing information for trends and initiatives that map impact AAPM&R members and assists in developing quality programs and practices for PM&R physicians. Continually builds and participates in a professional quality healthcare network.

• Coordination of research training courses and reporting of educational metrics to the Clinical and Translational Science Awards • Submission for INA and CME contact hours for all educational programs• Development of templates, research tools, & curriculum to be published on OCR website• Internal Auditor for University of Chicago Clinical Research Program• Program Director for IND/IDE FDA Support Center• Mentor for Clinical Research Associates

• Oversight of NIH Capacity Building Grant & SMART Study• Research Associate for Infectious Disease Clinical Trials• Coordination of outpatient HIV patient care as Inf Disease Cl. Man • Tracking of Quality Indicators and HIV Benchmarks• Patient and Staff Educator• Coordination and Clinician for Travel Clinic

• Product support for HIV portfolio• Special projects included: grant writing workshop for AID Service Organizations; Working with government affairs to work with MDs and legislatures to address ADAP’s 4 drug antiretroviral limit; and checking accuracy of new prescription data for the HIV division.

• Oversight of Ryan White Title I Grant for Primary Care• Research Associate for Inf. Disease Clinical Trials• Discharge Planning for HIV Seropositive Patients

• Oversight of all institutional HIV Testing & Counseling• Research Associate for Inf. Disease Clinical Trials

Fellow, Biomedical Ethics

Activities and Societies: MacLean Center for BioMedical Ethics

Certificate In Clinical Trial Management, Graham School Of General Studies

Bachelor Of Science In Nursing

Activities and Societies: Chi Omega; Synchronized Swimming

Education record

Education record

Education record