Sara Rauenhorst
Greenville
Summary
Dynamic Clinical Site Manager with extensive experience at Velocity Clinical Research, excelling in project management and ICH-GCP compliance. Proven track record of optimizing site operations and achieving EBITDA targets while fostering effective communication with stakeholders. Adept at implementing quality assurance processes to enhance data integrity across multiple clinical trials.
Overview
9
9
years of professional experience
1
1
Certification
Work History
Clinical Site Manager
Velocity Clinical Research
Anderson
04.2025 - Current
- Managed and led a team of coordinators, research assistants, and clinical support associates.
- Oversaw site operations and budgets to optimize financial performance.
- Tracked revenue, ensuring EBITDA targets were consistently met.
- Established relationships with CROs, sponsors, healthcare providers, and patients.
- Managed trials from pre-site selection through closeout at site level.
- Ensured high-quality data through comprehensive training and quality assurance checks.
- Implemented new processes at site level to enhance operational efficiency.
- Completed feasibility studies, startup documents, IRB submissions, and regulatory paperwork.
Site Operations Supervisor
Velocity Clinical Research
Anderson
11.2024 - 03.2025
- Oversee and manage trials from pre-site selection to close out at the site level.
- Ensuring high quality data through thorough training and quality assurance checks.
- Establish and implement new site level processes.
- Complete feasibilities, invoicing, site qualification visits, close out visits, and site initiation visits.
- Responsible for study IP accountability, performing patient visits, and corresponding with sponsors and CROs.
- Creating and reviewing delegation logs, 1572s, Source Data Agreements, FDFs, and training logs.
Senior CCRC
Velocity Clinical Research
Anderson
01.2023 - 11.2024
- Managed 24 concurrent phase 1-4 clinical trials at CCRC.
- Assisted in feasibilities, invoicing, site qualification visits, and CAPAs.
- Mentored and trained new clinical staff to enhance team capabilities.
- Ensured study IP accountability, conducted patient visits, and communicated with sponsors and CROs.
- Created and reviewed delegation logs, 1572 forms, Source Data Agreements, FDFs, and training logs.
Clinical Research Coordinator II
Velocity Clinical Research
Anderson
04.2022 - 01.2023
- CCRC on 20+ phase 1 - 3 clinical trials.
- Responsible for study IP accountability, complete study visits as per protocol, training and mentoring new clinical staff, complete quality assurance checks, performing ECGs, spirometry, IMP administration, and blood draws.
- Trained and mentored new clinical staff to enhance team competency.
- Performed quality assurance checks to ensure compliance with standards.
- Administered ECGs, spirometry, IMP, and blood draws as part of study procedures.
Clinical Research Coordinator
Tribe Clinical Research
07.2019 - 04.2022
- Conducted CRC for 21 phase 1-3 clinical trials, ensuring compliance with protocols.
- Maintained accountability for study investigational products throughout trial phases.
- Executed study visits in accordance with established protocols and timelines.
- Trained and mentored new clinical staff to enhance team capabilities.
- Performed quality assurance checks to uphold data integrity and protocol adherence.
- Administered IMP, conducted ECGs, and carried out blood draws as required.
- Processed and shipped laboratory specimens efficiently.
- Completed data entry tasks accurately to support trial documentation.
Medical Assistant
Parkside Pediatrics
04.2019 - 12.2019
- Documented comprehensive patient histories, including medications, allergies, and vital signs.
- Collected nasal swabs, throat swabs, and blood samples for diagnostic analysis.
- Prepared and administered vaccines along with therapeutic injections to ensure patient care.
Emergency Department Medical Scribe
ScribeAmerica
06.2017 - 04.2019
- Increased emergency physician efficiency by charting patients' history of present illness, physical exam findings, medical decision making, laboratory results, and imaging results in a level 1 trauma center.
Education
Bachelor of Science - Psychology
Clemson University
Clemson05-2017
Skills
- ICH-GCP compliance
- Project management
- Effective communication
- Quality assurance
- CTMS proficiency
- Detail oriented
- Microsoft Office suite
- Regulatory documentation expertise
- EDC expertise
Certification
- CCRC
- GCP
- IATA
- BLS
Clinical Research Experience
Experience on over 90 clinical trials, phase I - IV in a vast range of therapeutic areas including; respiratory, vaccines, women's health, CNS, autoimmune disorders, cardiometabolic, prevention / treatment medication trials (UTI, COVID, flu), chronic kidney disease, endocrine, device, chronic rhinosinusitis, pediatrics.
Timeline
Clinical Site Manager
Velocity Clinical Research
04.2025 - Current
Site Operations Supervisor
Velocity Clinical Research
11.2024 - 03.2025
Senior CCRC
Velocity Clinical Research
01.2023 - 11.2024
Clinical Research Coordinator II
Velocity Clinical Research
04.2022 - 01.2023
Clinical Research Coordinator
Tribe Clinical Research
07.2019 - 04.2022
Medical Assistant
Parkside Pediatrics
04.2019 - 12.2019
Emergency Department Medical Scribe
ScribeAmerica
06.2017 - 04.2019
Bachelor of Science - Psychology
Clemson University