INGRID C. WELCH, BS
Suwanee,Georgia
Summary
Dedicated healthcare professional with over 10+ years of experience in patient care with an extensive knowledge in Nursing that includes critical thinking, patient safety and ethical standards. Devoted to learning professional competencies that enhances my service to others. Excellent attention to detail and great interpersonal skills allowing for multi-level collaboration. Highly-motivated with a desire to take on new challenges.
Capable of applying regulatory practices from start to finish. Attentive with demonstrated success in handling domestic and international regulatory needs for diverse products. Systematic and practical with sound judgment, an analytical mindset and good problem-solving skills.
Overview
12
12
years of professional experience
1
1
Certification
Work History
EXPERIENCE, Clinical Research Assistant/Regulatory Compliance Specialist
M3 Wake Research/ Mount Vernon Clinical Research
Sandy Springs, GA
01.2023 - Current
- Assist the study staff in the protection of the rights and welfare of all human research participants involved in research study trials as according to ICH E6 GCP Principles, ALCOA-C and HIPPA).
- Maintain the Investigational Site File for each study by ensuring all documents needed to initiate the study are properly filed (1572, FDF, Training Logs, etc.)
- Adhere to clinical research standards and FDA guideline by ensuring the integrity of study and regulatory data.
- Maintain data management on several Clinical Trial Management Systems (CTMS).
- Maintain correspondences via CIBRI/Advarra regarding AE’S, MAAEs and SAEs.
- Perform study-related procedures according to the study protocol.
- Work to assure an efficient workflow including organizing clinical work areas, ordering lab kits, shipping materials, tracking and replacing expired lab kits.
- Attending weekly staff meeting that includes updates and training.
- Attends investigator meeting for assigned studies as required.
- Organized and maintained all documents related to regulatory updates and correspondence.
- Maintained open communication with team members, CROs and sponsors, resulting in successful clinical trial outcomes.
- Prioritized and organized tasks to efficiently accomplish work goals.
- Collaborated with team members to identify areas of improvement.
- Maintaining protocol instructions for the quality and improvement of patient safety.
Patient Enrollment Coordinator
M3 Wake Research / Mount Vernon Clinical Research
Sandy Springs, GA
01.2022 - 01.2023
- Perform Institutional Review Board (IRB) and Health Insurance Portability and Accountability Act (HIPPA) standards.
- Maintained Good Clinical Practice, ICH guidelines and SOPs.
- Ensured compliance with HIPAA regulations by maintaining confidentiality of patient information.
- Manage interaction with subject participants including eligibility screening and recruitment
- Understanding of study protocol Inclusion/Exclusion Criteria
- Schedule new subjects and facilitate follow-up appointments
- Manage multiple clinical trials simultaneously
- Design recruitment strategies, recruit potential subjects and determine subject eligibility
- Work directly with Sponsors Clinical Trial Educators to increase enrollment for various studies
- Manage Sponsor and CRO platforms for recruitment: Access GSK, Autocruitment, Citeline/Trialscope, IQVIA, Mylan Splash Clinical, Pfizer My Patient, Proof Pilot and Trial Partners.
- Maintained accurate data entry in various databases related to study enrollments
- Responsible for day-to-day activities to ensure the successful completion of enrollment for each study.
- Trained new enrollment team members on potrocol standards ( Schedule Of Events and Inclusion/Exclusion)
- Answered questions and responded to inquiries to deliver high level of service to patients.
- Developed and implemented strategies to increase study enrollment.
Patient Accounting Associate
PricewaterhouseCoopers-Memorial
01.2021 - 01.2022
- Sloan Kettering Cancer Center Account
Patient Care Technician II
Northside Hospital Gwinnett
Lawrenceville, GA
01.2016 - 01.2021
- Provide clinical care for assigned COVID-19 patients
- Report abnormalities or concerns to the RN
- Check and document vital signs, intake/output, and blood glucose levels
- Responsible for placement of telemetry leads for critical and acute care patients
- Monitor JP and Hemovac drains
- Educate patients on spinal precautions and assist with back brace and Aspen collar training
- Responsible for straight catheterization every 4/6 hours as needed
- Check patient rooms for safety and fall precautions
- Assist with mobilization, repositioning, and toileting
- Stock patient carts and infection control servers each shift for assigned rooms.
Medication Technician/Patient Care Technician
The Oaks Senior Living
Cumming, GA
01.2015 - 01.2016
- Certified as Medication Technician on-site
- Verified resident ID, per prescription, for authentication
- Responsible for preparing and dispensing prescribed medication, per doctor’s written orders
- Observed ingestion/application of medicine for possible side effects and/or allergic reactions
- Documented resident vital signs (as required for certain medications)
- Daily counted narcotics medication
- Knowledge of Hypo and Hypertension; Hypo and Hyperglycemia - Diabetes Mellitus
- Reviewed end-of-shift report with incoming medication technician—communicating variations in patient’s disposition and/or current needs to maintain continuity of care
- Completed appropriate documentation to verify patient care provided.
Patient Care Technician
St. Vincent Medical Center
Jacksonville, FL
01.2013 - 01.2015
- Assisted patients with daily grooming needs in accordance with established care plan
- Recorded vital signs, height, weight, input/output, collect specimens, report, and record patient’s condition and patient treatments
- Helped patients with their mobility (i.e., turn and positioning, transferring patients to and from wheelchair, helped with ambulation)
- Assisted with routine catheter and colostomy bag care
- Aide in resolving patients care issues by working closely with the nurses
- Completion of Bedside Shift Report and ensuring Falls Bundle is intact.
Personal Care Specialist/Medication Technician
North Florida Retirement Village
Gainesville, FL
01.2012 - 01.2013
Education
Certified Phlebotomy Technician -
Georgia School of Phlebotomy
04-2022
Bachelor of Science - Health Information Management
Southern New Hampshire University
Patient Care Technician -
New Horizons Medical Institute
Skills
- Ethics Protocol Adherence
- Laboratory Results Management
- Trial Oversight
- Research Experience
- Phlebotomy
- Documentation Requirements
- Case Report Management
- Documentation Management
- Records Maintenance
- Specimen Collection and Handeling
- Pharmaceutical Sponsor Guidelines
- Problem-Solving
- Quality Assurance
- Database Organization
- Data Analysis
- Protocol Review
- Scheduling Proficiency
Affiliations
BLS/CPR American Heart Association
CITI PROGRAM & MAYO CLINIC
Good Clinical Practice (GCP) (2022-2024) Biomedical Research (2022-2025)
IATA – (2022-2024)
Certification
- American Health Information Management
- The National Society of Leadership and Success (Honor Society)
- Greenlight Guru FDA 510(k) Overview
- RAPS Role of the Regulatory Professional
Additional Information
- (License #CN0030007141) Florida Board of Nursing
- (License #CNA266320) Patient Care Technician New Horizons Medical Institute
- (License #E6Q8P3Z3) National Health Career Association
- American Health Information Management (AHIMA)
- The National Society of Leadership and Success (Honor Society)
- TECH SAVVY: Florence, CIBRI/Advarra, iMedidata, Longboat, PPD Preclaurs, EMR/EHR Database, Clinical Conductor (CTMS), Microsoft Office Suites
Timeline
EXPERIENCE, Clinical Research Assistant/Regulatory Compliance Specialist
M3 Wake Research/ Mount Vernon Clinical Research
01.2023 - Current
Patient Enrollment Coordinator
M3 Wake Research / Mount Vernon Clinical Research
01.2022 - 01.2023
Patient Accounting Associate
PricewaterhouseCoopers-Memorial
01.2021 - 01.2022
Patient Care Technician II
Northside Hospital Gwinnett
01.2016 - 01.2021
Medication Technician/Patient Care Technician
The Oaks Senior Living
01.2015 - 01.2016
Patient Care Technician
St. Vincent Medical Center
01.2013 - 01.2015
Personal Care Specialist/Medication Technician
North Florida Retirement Village
01.2012 - 01.2013
Certified Phlebotomy Technician -
Georgia School of Phlebotomy
Bachelor of Science - Health Information Management
Southern New Hampshire University
Patient Care Technician -
New Horizons Medical Institute
- American Health Information Management
- The National Society of Leadership and Success (Honor Society)
- Greenlight Guru FDA 510(k) Overview
- RAPS Role of the Regulatory Professional
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