Amanda J Sims
Alton
Summary
With over 20 years of experience in the research field, I have honed my skills in a clinical research environment, specializing in data analysis, laboratory techniques, and protocol adherence. Throughout my career, I have consistently showcased my ability to effectively manage clinical samples and maintain accurate records, ensuring data integrity and compliance. Now, I am eager to leverage these valuable transferrable skills in a new and challenging role.
Overview
26
26
years of professional experience
1
1
Certification
Work History
Clinical Research Technician/PRN
Arch Clinical Trials
03.2024 - Current
- Promoted a positive environment for study participants through compassionate care, prompt scheduling adjustments, and thorough explanations of complex concepts.
- Collaborated effectively with multidisciplinary teams for optimal clinical trial progress and outcomes.
- Expedited the review process by accurately assembling required documentation for submission to regulatory agencies.
- Assisted in the development of study protocols to ensure compliance with ethical guidelines and industry regulations.
- Maintained a high level of professionalism while working under pressure during demanding research projects.
- Optimized data accuracy through rigorous attention to detail while entering results into electronic databases.
Phlebotomy Site Coordinator
LabCorp
05.2021 - Current
- Provide coverage and travel to various sites
- Assist in the supervision of a team of multiple phlebotomists covering multiple locations
- Improved site safety standards by conducting regular inspections and enforcing compliance with health and safety regulations.
- Complete new hire annual competency assessments
- Manage and monitor patient flow, wait times, inventory levels and information logs
- Address any customer service issues in a prompt and respectful manner
- Review daily/weekly schedule with supervisor and make appropriate adjustments as needed
- Facilitated training sessions for new staff, enhancing team capabilities and ensuring consistent quality of work.
- Mentored junior staff members, sharing knowledge and expertise to promote professional growth within the team.
Laboratory Coordinator/ CRA
BioPharma Services Research
01.2019 - 06.2023
- Manage study specific lab kits, performing EKG’s and specimen collection, processing, and shipment of PK labs with strict adherence to OSHA and IATA requirements
- Maintained a safe and organized lab environment by enforcing strict adherence to safety guidelines and lab protocols.
- Supervise laboratory assistants to ensure all study specimens are processed and archived according to protocol specifications
- Streamlined sample processing and data analysis, ensuring timely delivery of accurate results to researchers.
- Notify the appropriate management staff of missed time-points, insufficient sample collection, improper specimen collection or unusual incidents
- Enter data into EDC in a timely manner
- Performs duties of processing, archiving and/or shipping out of specimens
- Share the responsibility for the overall coordination, organization, management, and efficient implementation of clinical trials
- Investigated and resolved issues related to laboratory processes and procedures.
- Completes all study related procedures and distributes study medication and instructions to research subjects under the direction of the PI and the site director
- Knowledgeable of guided FDA regulations, GCP, IRB, and standard operating procedures and policies
Study Coordinator/ Medical Oncology
Washington University South County Campus
11.2020 - 05.2021
- Provide information about the RPR to potential participants, either in person or by phone, and interview potential participants for studies
- Work with investigators and coordinators for recruitment needs and study referrals
- Review and obtain informed consent form with potential study volunteers
- Streamlined communication between participants and research team, fostering effective collaboration and data collection.
- Work with clinical team to address any scheduling or enrollment issues
- Obtain medical history and adverse events at scheduled visits
- Manage study specific lab kits, performing EKG’s and specimen collection, processing, and shipment of PK labs with strict adherence to OSHA and IATA requirements
- Follow site SOP’s and protocol mandated instructions, and obtain detailed knowledge of all components of each study protocol through review and analysis of study information with PI and Site Director prior to effective date of the study
- Notify the appropriate management staff of missed time-points, insufficient sample collection, improper specimen collection or unusual incidents
- Share the responsibility for the overall coordination, organization, management, and efficient implementation of clinical trials
- Completes all study related procedures and distributes study medication and instructions to research subjects under the direction of the PI and the site director
- Knowledgeable of guided FDA regulations, GCP, IRB, and standard operating procedures and policies
Laboratory Manager
St. Louis Clinical Trials/ERG
08.2018 - 03.2020
- Maintains accurate confidential files and documentation of study participants
- Screen, enroll subjects, and schedule subject visits in conjunction with the PI
- Review and obtain informed consent form with potential study volunteers
- Assist Clinical research coordinators by maintaining the laboratory in a neat and organized fashion
- Manage study specific lab kits, performing EKG’s and specimen collection, processing, and shipment of PK labs with strict adherence to OSHA and IATA requirements
- Monitor study for accuracy per the protocol, and close out study in a timely manner to meet deadlines
- Expedited study start-up timelines by efficiently coordinating site initiation visits, trainings, and equipment setup.
- Supervise laboratory assistants to ensure all study specimens are processed and archived according to protocol specifications
- Notify the appropriate management staff of missed time-points, insufficient sample collection, improper specimen collection or unusual incidents
- Assist in maintaining the specimen processing area is clean, set up according to protocol requirements and that all required supplies are stocked
- Travel to other sites within the company to oversee laboratory functions pertaining to specific studies
- Enter data into EDC in a timely manner
- Share the responsibility for the overall coordination, organization, management, and efficient implementation of clinical trials
- Completes all study related procedures and distributes study medication and instructions to research subjects under the direction of the PI and the site director
- Knowledgeable of guided FDA regulations, GCP, IRB, and standard operating procedures and policies
Phlebotomist Level lll/CRA
Gateway Medical Research/Cetero/Pracs/Pharma Medica Research
06.1999 - 08.2018
- Assist in recording adverse events
- Review and correct study documentation
- Collection of pre-dose and post-dose timed blood draws following the SOP’s and study protocol
- Perform check-in procedures (belonging search, urine collection, drug of abuse screening, cotinine screening, urine pregnancy testing, and breath alcohol testing)
- Study specific sample processing and storage
- Monitor clinical activities
- Follow GCP, OSHA and SOP guidelines
- Study preparation (tube labeling, bunk room preparation, set up phlebotomy stations)
- Assist in dosing procedures by performing mouth check
- Perform any tasks required by management deemed necessary to conduct a clinical study
- Serve and monitor meals
- Perform vital signs according to study protocol
- Perform ECG according to study protocol
- Perform general cleaning duties (decontaminate workstations, equipment such as centrifuges and refrigerators
- Assist the Clinical Coordinators with compilation of study files after study completion
- End of study procedures as needed per the study specific protocol
Phlebotomy Supervisor
Diagnostic Cytology Laboratories
08.2004 - 10.2009
- Developed comprehensive training programs for new hires, ensuring they were equipped with necessary skills to succeed in their roles.
- Monitored customer service and supported staff in resolving patient concerns to maximize workflows.
- Supervised employees at multiple sites and reporting locations to maintain consistent practices across company.
- Conducted regular performance evaluations for phlebotomy staff, providing constructive feedback and identifying areas for growth.
- Conducted regular audits to verify compliance with regulatory requirements and maintain accreditation status for the phlebotomy department.
- Managed effective schedules to cover all department needs.
Education
General Studies - Speech Pathology
Lewis & Clark College
Godfrey, IL01.1993
High School Diploma -
Roxana High School
Roxana, IL01.1990
Skills
- Regulatory requirements understanding
- GCP guidelines
- ICH guidelines
- Communication
- Medical terminology
- Independent initiative
- Decision making
- Leadership
- Travel
- Excellent communication
- Basic computer skills Word/Excel
- Clinical research
- Phlebotomy
- Vitals
- ECG
- CRF documentation
- Customer relations
- Electronic data capture
- Staff supervision
- Study progress tracking
- Adaptable problem-solving
- Informed consent process
- Adverse event reporting
- Patient care
- Laboratory techniques
- Professionalism and ethics
- Sample processing
Certification
- CPR
- IATA
- GCP
Prior Work Experience
- Christian NE Hospital, Phlebotomist, 1993, 1994
- Alton Multi Specialist, Phlebotomist, 1994, 1999
- St. Anthony’s Hospital, PRN Phlebotomist, 2013, 2014
Timeline
Clinical Research Technician/PRN
Arch Clinical Trials
03.2024 - Current
Phlebotomy Site Coordinator
LabCorp
05.2021 - Current
Study Coordinator/ Medical Oncology
Washington University South County Campus
11.2020 - 05.2021
Laboratory Coordinator/ CRA
BioPharma Services Research
01.2019 - 06.2023
Laboratory Manager
St. Louis Clinical Trials/ERG
08.2018 - 03.2020
Phlebotomy Supervisor
Diagnostic Cytology Laboratories
08.2004 - 10.2009
Phlebotomist Level lll/CRA
Gateway Medical Research/Cetero/Pracs/Pharma Medica Research
06.1999 - 08.2018
General Studies - Speech Pathology
Lewis & Clark College
High School Diploma -
Roxana High School