Sheila Richardson
Cincinnati,Ohio
Summary
To obtain a position in Clinical Research Seasoned nursing professional offering proven clinical knowledge, natural interpersonal strengths and technical abilities. Knowledgeable about EMR charting, medication administration and interdisciplinary collaboration focused on optimizing patient care and support. Quality-focused and efficiency-driven leader.
Overview
14
14
years of professional experience
Work History
Lead CRC
Velocity Clinical Research
10.2022 - Current
- Lead CRC on several independent vaccine, weight loss, and diabetes studies
- Ensure compliance with applicable ICH-GCP guidelines, local regulatory requirements, SOP's and specific procedures
- Screen Subjects for eligibility using protocol specific inclusion and exclusion criteria documenting each potential participants eligibility or exclusion
- Review and develop familiarity with protocols, study procedures and timelines confidentiality, privacy protections and various study specific software platforms
- Obtain and document informed consent forms are appropriately completed according to sponsor requirements
- Respond to site monitoring visits, findings, consult with PI and implement approved recommendations
- Maintain documentation informed consent and answer participants questions related to the study
- Prepare study materials including informed consent, documents case report forms, enrollment logs and instrument/device accountability
- Establish and organize regulatory binders, study specific documentation and other study related materials
- Blood Draws for specific study related documentation
Lead CRC and Co-Lead
Synexus Clinical Research now Thermo Fischer
03.2021 - 10.2022
- Lead CRC and Co-Lead on Vaccine trials
- Ensure compliance with applicable ICH-GCP guidelines, local regulatory requirements, SOP's and specific procedures
- Screen Subjects for eligibility using protocol specific inclusion and exclusion criteria documenting each potential participant participants eligibility or exclusion
- Review and develop familiarity with protocols, study procedures and timelines confidentiality, privacy protections and various study specific software platforms
- Obtain and document informed consent forms are appropriately completed according to sponsor requirements
- Respond to site monitoring visits, findings, consult with PI and implement approved recommendations
- Maintain documentation informed consent and answer participants questions related to the study
- Prepare study materials including informed consent, documents case report forms, enrollment logs and instrument/device accountability
- Establish and organize regulatory binders, study specific documentation and other study related materials
- Blood Draws for specific study related documentation
- Studies Lead CRC and Co-Lead CRC Moderna studies for CMV, RSV, Covid /Flu combo, Pfizer RSV, GSK RSV, Novavax Covid, Iqvia Lipid study, Currax weight loss drug
Crossroad Health Care Center
03.2016 - 03.2021
- Worked closely with M.D.'s and NPs in a clinical patient care setting
- Blood draws, POC services and maintained all intake and continuity of care in a primary care setting for the underinsured and low socioeconomic population
- OB care and Addiction care health
- Worked closely with our therapists for mental health care
- Maintained supply orders
Quenn City ENT
02.2011 - 03.2016
- Worked with highly specialized Otologist
- Performed surgeries in office for multiple ear issues
- Maintained sterilization of instruments and microscopes for micro surgeries
- Maintained specimen logs
- Performed blood draws and ordering of supplies
- Performed allergy testing, PFT's, breathing treatments, IT therapy, mixed vials for IT therapy
Education
Associates Degree of Nursing -
Santa Monica College
Santa Monica, CA01.1998
Bachelors of Science of Nursing -
Northern Kentucky University
01.1994
Skills
- Training and coaching
- Strategic Thinking
- Customer Focus
- Visual Management
- Strong Clinical Judgment
- Performing EKGs
- Vaccine administration
- Medication Distribution
- Documentation and Charting
Timeline
Lead CRC
Velocity Clinical Research
10.2022 - Current
Lead CRC and Co-Lead
Synexus Clinical Research now Thermo Fischer
03.2021 - 10.2022
Crossroad Health Care Center
03.2016 - 03.2021
Quenn City ENT
02.2011 - 03.2016
Bachelors of Science of Nursing -
Northern Kentucky University
Associates Degree of Nursing -
Santa Monica College
Similar Profiles
Michael WatersMichael Waters
Medical Director and Principal Investigator at Velocity Clinical ResearchMedical Director and Principal Investigator at Velocity Clinical Research
Alyssa PrecilAlyssa Precil
Clinical Operations Director at Velocity Clinical ResearchClinical Operations Director at Velocity Clinical Research
Tracey PhelpsTracey Phelps
Site Manager at Velocity Clinical ResearchSite Manager at Velocity Clinical Research