Summary
Overview
Work History
Education
Skills
Certification
Timeline
Generic

Stacy Gonzales

Meridian

Summary

Experienced in clinical research operations and team management, skilled at fostering team collaboration to achieve study goals. Proficient in overseeing all project aspects, including contract and budget negotiations, adhering to IRB and FDA regulations, and direct patient care. Skilled in phlebotomy, building source documents, SOP development, and delivering high-quality results. Committed to advancing healthcare through dedication and expertise.

Overview

19
19
years of professional experience
1
1
Certification

Work History

Site Director

Treasure Valley Medical Research
01.2021 - Current
  • Successfully implements and executes phase I - IV clinical trials.
  • Manage negotiation, finalization, accounting and tracking of investigator Clinical Trial Agreements, budgets, payments both at the site and subject level.
  • Ensure compliance with regulations, guidelines and policies for studies implemented at the site
  • Managing staff and ensure all training is up to date.
  • Creation and implementation of SOPs.
  • Ensure proper ICF process for each trial.
  • Completing, reviewing and submitting regulatory documents.
  • Coordinating site trial activities and processes.
  • Quality Assurance with all trials.
  • Coordinate site training, product delivery, supply management, etc. Ensure protocol compliance.
  • Ensure all safety issues are communicated and managed by Principal Investigator and study team in the appropriate timelines.
  • Maintain staff GCP/ICH requirements.
  • Manage all monitoring visits onsite or via telephone.
  • Prepare for and manage sponsor or regulatory inspections.
  • Collaborate and actively manage the active/closed clinical trials.
  • Attend Investigator meetings.
  • Hiring and human resource activities.
  • Develop strong working relationships and maintain effective communication with study team members.
  • Track key study metrics using tracking tools (creating and maintaining documents, tables, databases, spreadsheets, and files), providing timely and quality updates to management.
  • Adhere to an IRB-approved protocol
  • Educate subjects on protocol, study intervention, study drugs, etc.
  • Facilitate pre-study, site qualification, study initiation, monitoring visits, and study closeout activities.
  • Conduct telephone screenings; in person screenings to recruit potential subjects.
  • Collects and records study data. Inputs all information into database
  • Coordinate protocol-related research procedures, study visits, and follow-care.
  • Obtains informed consent under minimal supervision of the investigator(s) and educates participants regarding study requirements.
  • Assists in the activities related to clinical research studies including but not limited to: answering phone calls, screening participants for eligibility, registering subjects with sponsoring agency, administering lifestyle questionnaires.
  • Conducts medical assessments including but not limited to: vitals, ecg, specimen collections, phlebotomy, injections, skin test, spirometry, scheduling of medical imaging, endoscopies, hearing exam
  • Maintains source documents and subject files in accordance with company procedures. Ensures accurate and complete compilation of subject data through chart reviews.
  • Secures, delivers and ships clinical specimens (Blood, urine, stool, skin scrapings, etc) as required by the protocol.
  • Follow all FDA, Good Clinical Practice (GCP) and ICH guidelines
  • Additional duties as needed to help the site function.

Clinical Research Coordinator

Saltzer Health
01.2017 - 01.2021
  • Ensuring trial compliance and aligned with project goals.
  • Creating and implementing study-specific clinical monitoring tools and documents.
  • Creating and overseeing trial budget.
  • Completing, reviewing and submitting regulatory documents.
  • Coordinating site trial activities and processes.
  • Coordinating, training and completing all ICF processes.
  • Coordinating and supervising all active/closed trails.
  • Creation of source documents per sponsor protocol
  • Providing Clinical Research Associates with project-specific training
  • Staff meetings
  • Recording and sharing interactions with subjects and Sponsors
  • Arranging and overseeing site visits.
  • Gathering and creating trial documents.
  • Adhering to local regulations, and CFR, ICH and GCP guidelines.
  • Prepare for and manage sponsor or regulatory inspections as needed.
  • Develop strong working relationships and maintain effective communication with study team members.
  • Track key study metrics using tracking tools (creating and maintaining documents, tables, databases, spreadsheets, and files), providing timely and quality updates to management.
  • Adhere to an IRB-approved protocol
  • Educate subjects on protocol, study intervention, study drugs, etc.
  • Facilitate pre-study, site qualification, study initiation, monitoring visits, and study closeout activities.
  • Conduct telephone screenings; in person screenings to recruit potential subjects.
  • Collects and records study data. Inputs all information into database
  • Coordinate protocol-related research procedures, study visits, and follow-care.
  • Obtains informed consent under minimal supervision of the investigator(s) and educates participants regarding study requirements.
  • Assists in the activities related to clinical research studies including but not limited to: answering phone calls, screening participants for eligibility, registering subjects with sponsoring agency, administering lifestyle questionnaires.
  • Conducts medical assessments including but not limited to: vitals, ecg, specimen collections, phlebotomy, injections, skin test, spirometry, scheduling of medical imaging, endoscopies, hearing exam
  • Maintains source documents and subject files in accordance with company procedures. Ensures accurate and complete compilation of subject data through chart reviews.
  • Secures, delivers and ships clinical specimens (Blood, urine, stool, skin scrapings, etc) as required by the protocol.
  • Follow all FDA, Good Clinical Practice (GCP) and ICH guidelines
  • Plus, any additional duties as assigned

Certified Medical Assistant

St. Alphonsus
01.2017 - 01.2017
  • Cross-trained to monitor and perform appointment/patient scheduling.
  • Answers phones, screens calls and takes messages. Answers incoming calls for adding or cancelling appointments to provider schedules. Verifies phone number, date of birth, and insurance information.
  • Scan documents into the Electronic Medical Record as necessary for patient documentation.
  • Completes sign-in of patients documenting arrival time and updating patient demographic and insurance carrier.
  • Makes return appointments during patient check-out.
  • Verifies enrollment eligibility by using the member eligibility through the insurance websites.
  • Processes cancellations and no-shows according to protocols.
  • Prepares exam rooms and equipment for each appointment.
  • Takes vital signs, documents patient’s allergies, completes clinical records, and prepares patient for physician examination and treatment.
  • Assists provider with examinations and procedures
  • Assists with other nursing and laboratory procedures under the supervision of licensed nursing personnel or medical provider.
  • Maintains cleanliness of all clinical area, washes and sterilizes instruments, maintains adequate stock of supplies. Orders lab supplies.
  • Performs phlebotomy using skilled techniques following nursing policy and procedures regarding labeling, transport, accession into lab computer.
  • Performs waive testing procedures using skilled techniques following laboratory policy and procedures.
  • Demonstrates patient advocacy which assures patients' right to privacy, safety, and confidentiality.
  • Understands HIPAA requirements and conducts clinical and business processes that ensures patient privacy as a priority.
  • May schedule patient appointments for follow-up visits, no-show, and referrals to other providers and agencies as indicated.
  • Answers and directs all incoming calls and handle appropriately. Takes messages and gives routine information in accordance with established procedures. Accurately documents all messages; gets messages to provider timely; and ensures patient has a return call regarding their request or concern.
  • Completes appropriate forms as directed per supervisor.
  • Other duties as assigned.

Office Coordinator/Medical Assistant

Interventional and Vascular Consultants, PC
01.2011 - 01.2016
  • Working from the site and remotely from home, offer friendly, courteous assistance to every patient to ensure the patient has a positive, professional experience.
  • Medical Administrative Support.
  • Professionally and efficiently handle incoming inquiries and requests from patients, ensuring that issues are resolved both promptly and thoroughly.
  • Gather patient information, fulfill patient needs, educate patients, where applicable, to prevent the need for future contacts and document interactions in applicable systems.
  • Provide quality service and support in a variety of areas which may include, but not limited to scheduling, registration, care coordination and billing collection efforts. patient inquiry calls
  • Use EPIC and Outlook calendars to schedule new consults, follow-up clinic appointments, Reschedule cancelled appointments.
  • Confirm appointments and answer questions about location, parking, what to bring, etc.
  • Complete registration in EPIC for all scheduled patients. Contact patients and/or family members to obtain accurate pre-registration information, including insurance information.
  • Maintain familiarity with types of medical insurance accepted in the clinic, noting participating and non-participating plan status.
  • Assist patients with insurance and third-party queries and explain payment policies.
  • Verify patients’ coverage, deductibles, co-pay, and co-insurance requirements before scheduling clinic appointments.
  • Coordinate patient follow-up visits.
  • Coordinate scheduling related procedures with other service areas or referring Physicians.
  • Coordinate with patients and/or referring Physicians to obtain outside medical records (including imaging studies). Ensure documents are scanned into EPIC in advance of clinic appointments.
  • Maintain records of incoming faxed and mailed clinical documents. Scan all patient and billing-related documents into EPIC, then dispose of paper documents.
  • Upon first clinical appointment, and before delivery, collect patient deductibles, co-pay, co-insurance, and self-pay amounts.
  • Assist billing team with collections of outstanding balances from insurance and patients.
  • Participate in monthly meetings to review collection activities.
  • Answer patient questions about billing. Guide patients and their families to appropriate resources (e.g., Financial Counseling or International Department) for information, guidance, or assistance regarding costs of and funding for care being provided.
  • Direct patients to appropriate resources/clinical areas, as needed.
  • Answer calls to clinic phone line from patients/family members, Physicians and insurance payers. Provide information, as needed.
  • Check clinic voice mail and return all calls within 24 hours.
  • Send clinically relevant patient messages to Clinicians via email.
  • Check EPIC In-basket messages daily and respond, per department policy.
  • Schedule meetings/maintain calendars for Clinicians.
  • Provide general administrative support to Clinicians.
  • Order and maintain office, clinic, and laboratory supplies, as needed.

Medical Assistant

Compass Oncology
01.2010 - 01.2011
  • Order and maintain office, clinic, and laboratory supplies, as needed.

Medical Assistant

NW Surgical Oncology, PC
01.2007 - 01.2010

Education

Associates of Applied Science - Medical Assistant

Apollo College
Portland, OR
01.2007

Skills

  • Operational leadership
  • Operational planning
  • Operations management
  • Self motivation
  • Staff management
  • Quality assurance
  • Negotiation
  • Business development

Certification

  • AAMA, Certified Medical Assistant
  • AHA, BLS Provider (CPR and AED)
  • CITI GCP Certification CITI Basic Course Certified
  • Mayo Clinic: Shipping of Dangerous Goods (IATA)

Timeline

Site Director

Treasure Valley Medical Research
01.2021 - Current

Clinical Research Coordinator

Saltzer Health
01.2017 - 01.2021

Certified Medical Assistant

St. Alphonsus
01.2017 - 01.2017

Office Coordinator/Medical Assistant

Interventional and Vascular Consultants, PC
01.2011 - 01.2016

Medical Assistant

Compass Oncology
01.2010 - 01.2011

Medical Assistant

NW Surgical Oncology, PC
01.2007 - 01.2010

Associates of Applied Science - Medical Assistant

Apollo College

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Stacy Gonzales