Summary
Overview
Work History
Education
Skills
Certification
References
Languages
Timeline
Generic

Amanda Wood

Summary

Clinical Research Associate with extensive experience in clinical trials and regulatory compliance. Skilled in creating effective recruitment strategies, monitoring, maintaining high-quality data integrity. Recognized for strong communication skills and attention to detail, contributing to successful project execution.

Overview

21
21
years of professional experience
1
1
Certification

Work History

Clinical Research Associate 1, Sponson Dedicated

IQVIA/ROCHE
09.2022 - Current
  • Site Management & Compliance • Lead site selection, initiation, SIV, Onsite and Remote Monitoring, routine monitoring, and close-out visits in alignment with ICH-GCP and contractual requirements.
  • Recruitment Strategy • Develop, adapt, and track tailored subject recruitment plans to hit enrollment targets and enhance predictability.
  • Training & Communication • Deliver protocol-specific training to site staff and maintain open communication to manage expectations and swiftly address issues.
  • Quality Oversight & Documentation • Assess site practices for protocol adherence and regulatory compliance, escalate quality concerns, and document findings through reports and action plans.
  • Study Progress Tracking • Monitor regulatory submissions, enrollment metrics, CRF completion, and data query resolution to ensure timely, high-quality data flow.
  • Cross-functional Collaboration • Work closely with data management, safety, clinical operations, and other stakeholders to drive seamless project execution.

Clinical Research Coordinator

Synexus Clinical Research/PPD/ThermoFisher Scientific
02.2021 - 08.2022
  • Regulatory Oversight : Partner sponsors, CROs, IRBs, and investigators to ensure adherence to CFR, ICH-GCP, and IATA regulations.
  • Data & Documentation : Extract, transcribe, and synthesize study data; maintain CRFs, delegation logs, Form 1572 and informed consent. Draft IRB submissions for amendments, adverse events, and deviations; oversee lab specimen processing and reporting.
  • Site Coordination & Communication : Lead site start-up and monitoring with PI, sponsor, CRO, and IRB. Screen participants per protocol criteria, document eligibility, and resolve trial queries. Obtain and implement IRB-approved budget and protocol amendments.
  • Investigational Product Accountability : Track and document investigational product/device handling throughout the study.
  • Training & SOP Compliance : Train staff on SOPs, protocols, and regulatory updates; maintain certification and training records.

Medial Assistant II / Lead Technician

CCOM Sisters Grove Pavilion/ Penrose St Francis Medical Center (Centura)
01.2017 - 01.2021
  • Manage scheduling of appointments, deliveries, and time-sensitive tasks in a fast-paced, multi-departmental environment.
  • Gather and organize all required information to complete daily operations accurately and meet deadlines with various contracted partners.
  • Perform physical examinations under county, state, and federal regulations (DOT, Non-DOT, DoD contractors, civilian, asbestos, specialty, respirator), including specimen collection, shipping, regulatory documentation, and result reporting.
  • Place and track orders with budget-conscious decision-making and problem-solving when outsourcing is required.
  • Operate and navigate clinical and administrative systems: SYSTOC, EPIC, BisCom, Synapse, PACS, MediaManager, Outlook, Word, PowerPoint, Excel, and other Microsoft Office applications.
  • Provide clinic management support by tracking safety reports, equipment maintenance, inventory logs, budgetary considerations, and federal/non-federal reporting in the supervisor’s absence.

Imaging Service Specialist

Penrose Hospital (Centura)
12.2016 - 12.2017
  • Frontline point of contact for all Imaging Department visitors and callers.
  • Uphold a professional image for employees, visitors, administration, and board members.
  • Apply Good Documentation Practices to maintain schedules, solve problems, and address patient needs.
  • Support a multi-specialty department by prioritizing and executing time-sensitive assignments.
  • Management experience: co-managed staff, office budgeting, supply ordering, billing & coding, and diagnostic code assignment during an 8-month supervisor absence.

Medical Lab Assistant

Pikes Peak Community College Medical Office Technology Department
08.2015 - 08.2016
  • Classroom Operations • Organized clinic and lecture areas, managed invoices, confirmed and sorted supplies, stocked shelves, created labels, and maintained inventory logs. • Handled paperwork tasks including sorting, collating, stapling, and filing.
  • Time Management & Supervision • Implemented scheduling systems in a fast-paced, detail-oriented environment for staff and students. • Employed critical path analysis to supervise and guide students through complex problems.
  • Management & Instructional Support • Co-taught designated lab units alongside the instructor for one year. • Assisted with student oversight, budget maintenance, supply ordering, and organizational planning.

Therapy Aide and Clinical Assistant

Children’s Hospital Colorado
05.2011 - 10.2013
  • Supported medical treatment plans for patients aged 1 day to 18 years.
  • Assisted in multi-specialty treatment plans for patients ranging from pediatric to geriatric.
  • Coordinated scheduling for 75 staff and managed turnover of 250 patients daily while supporting front-office operations.
  • Monitored and adjusted ordering budgets and contract obligations, applying critical-path management to meet deadlines.
  • Ensured compliance with CDC and hospital safety protocols and oversaw maintenance of all therapeutic and project equipment.
  • Trained staff on feeding clinics, casting, aquatic therapy pool upkeep, equipment ordering/distribution, and specialized modalities.
  • Provided 2.5 years of interim management: co-managed team, office budget, supply ordering, billing/coding, diagnostic code assignment, and overall clinic operations.

Therapy Aide and Clinical Assistant

UCHealth/ Memorial Hospital
05.2011 - 08.2011
  • Supported medical treatment plans for patients aged 18 years to 95 years.
  • Coordinated daily patient scheduling and front-office operations.
  • Managed ordering budgets and contract obligations with critical-path planning to meet deadlines.
  • Ensured CDC and hospital safety/regulatory compliance and oversaw equipment maintenance.
  • Trained staff on specialty therapy equipment and targeted treatment modalities.
  • Provided 2½ years of interim clinic management: co-managed staff, budgets, ordering, billing/coding, diagnostic code assignment, and overall operations.

Kindergarten Educational Support Staff

School District 11 (James Monroe Elementary School)
04.2009 - 05.2011
  • Supervised children within my assigned kindergarten class, administered CSAP testing, and instructed children on learning and how to apply reading, writing, mathematics, spelling, basic computer skills, phonemic awareness, and alternative learning methods for school and life.

Special Education Para-Professional

Harrison School District # 2
08.2004 - 08.2009
  • Supervised children administered CSAP testing and instructed children on learning and how to apply reading, writing, mathematics, spelling, basic computer skills, phonemic awareness, and alternative learning methods for school and life.

Education

Bachelor of Science - Health Sciences Professional Development and Advanced Patient Care

Grand Canyon University
Remote
11.2018

Associates of Science - Medical Assisting, Minor Phlebotomy

Pikes Peak Community College
Colorado Springs, CO
04.2017

Associates of Science - Medical Billing and Coding, Minor of Applied Science

Colorado Technical University
Remote
03.2012

Skills

Clinical Trial Operations: Site selection, initiation, Onsite and Remote monitoring & close-out; protocol adherence; recruitment & patient engagement

- Regulatory Compliance & QA: GCP, ICH, FDA/CFR adherence; IRB submissions; informed consent; pharmacovigilance

- Data Management & Reporting: EDC/CTMS (Veeva Vault, Medidata Rave, QuoRUM); eTMF (Florence, MasterControl); clinical study reports

- Systems & Tools: IXRS, Controlant, Teckro, WCG Connexus, Clinical Conductor

- Project Management & Collaboration: Cross-functional leadership; timeline & budget management; training delivery; stakeholder communication

Certification

  • BLS/ CPR with AED, 2002 - Present
  • Council Accreditation Occupational Hearing Conservation / CAOHC, 2018 - Present
  • EKG/ECG Interpretations, 2016 - Present
  • Microsoft Projects Certification, In Process
  • Clinical Research Certification, In Progress
  • RMA, 2017 - Present

References

Available upon request.

Languages

English
Native/ Bilingual

Timeline

Clinical Research Associate 1, Sponson Dedicated

IQVIA/ROCHE
09.2022 - Current

Clinical Research Coordinator

Synexus Clinical Research/PPD/ThermoFisher Scientific
02.2021 - 08.2022

Medial Assistant II / Lead Technician

CCOM Sisters Grove Pavilion/ Penrose St Francis Medical Center (Centura)
01.2017 - 01.2021

Imaging Service Specialist

Penrose Hospital (Centura)
12.2016 - 12.2017

Medical Lab Assistant

Pikes Peak Community College Medical Office Technology Department
08.2015 - 08.2016

Therapy Aide and Clinical Assistant

Children’s Hospital Colorado
05.2011 - 10.2013

Therapy Aide and Clinical Assistant

UCHealth/ Memorial Hospital
05.2011 - 08.2011

Kindergarten Educational Support Staff

School District 11 (James Monroe Elementary School)
04.2009 - 05.2011

Special Education Para-Professional

Harrison School District # 2
08.2004 - 08.2009

Bachelor of Science - Health Sciences Professional Development and Advanced Patient Care

Grand Canyon University

Associates of Science - Medical Assisting, Minor Phlebotomy

Pikes Peak Community College

Associates of Science - Medical Billing and Coding, Minor of Applied Science

Colorado Technical University

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Amanda Wood