Clinical Research Study
Resume:
Alexandra Thomas
Clinical Study Manager
Dedicated Clinical Study Manager experienced
in effective leadership, strategic thinking, and
strong communication competency. Practiced
problem solver with strong attention to detail
having been delegated to over sixty protocols
covering phases I, II, III, and IV trails.
Experience spans multiple therapeutic
indications including OB-Gyn, urogynecology,
cardiology, Alzheimers, rare disease and
vaccine protocols.
Experience Education
November 2021 – May 2023
Clinical Study Manager Care Access Research, Boston, MA
Managed cross functional teams across sites and held teams accountable for delivery and success of trials as per protocol and timelines. Would assist in creating strategies to assist in a trial’s success onsite, status ensuring successful completion of project milestones and
parameters.
Acted as principal liaison between sponsor and client by facilitating the flow of information between all parties. Provided sponsors with project updates, ensuring correct protocol interpretations, and obtained direction on implementing scope of work.
Managed activities with a team from study start-up through study completion for assigned sites, including training and vendor management.
Assisted in internal site monitoring including source data verification and eCRF review.
Proficient in a range of vendor systems, including eTMF software including Veeva.
2021
Site Manager, Dual Sites Unified Women’s Clinical Research, Raleigh and Winston-Salem, NC
Monitored worksite personnel to maintain high levels of quality and performance while also complying with GCP, operational, and OSHA standards and regulations.
Assessed, optimized, and elevated study operations to target current and expected recruitment demands.
Maintained daily communication with site staff, sponsors, and CROs to drive forward progress of protocols.
2017-2021
Clinical Research Coordinator Unified Women’s Clinical Research, Winston-Salem, NC
Conducted clinical trials and adhered to strict standards involving research protocols, data collection, and regulatory management.
Obtained informed consent of research subjects or guardians and maintained proper source documentation.
Assisted CRO with pre-study, closeout and interim visits to monitor study activities.
Assessed drug storage conditions and procedures to check adherence to standard protocols. Dispensed IP to subjects under PI supervision.
Collected and processed laboratory specimens.
Bachelor of Science, Exercise
Science, May 2013
Appalachian State University,
Boone, NC
Cum Laude graduate
Dean’s List Honoree
Certifications
CCRC-ACRP
GCP
Contact
**************@*****.***
Winston-Salem, NC
References upon request.
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