• Lead cross functional teams at small to mid sized sponsors in inspection readiness activities. • Review regulatory submissions for quality and completeness (CSR, NDA).• Conduct TMF audits. Skilled in Veeva systems. • Coach and train study management teams on inspection readiness strategy.• Lead teams to create and present knowledge maps and storyboards.• Develop and maintain eLearning courses• Train and lead beta tester team.• Project management of products throughout the life-cycle.• Manage company operations• Develop company SOPs and write policies• Maintain company GDPR compliance• Manage vendors and personnel• Compose copy on global regulations and guidelines and new topics in clinical research• Maintain company social media networking

• Provided complex nursing care for medically fragile children in their homes• Assessed medical status, cared for tracheostomy and gastric tubes, administered medications per doctor orders• Assisted with physical therapy and occupational therapy goals• Documented nursing actions and procedures, observations, drug administration.

• Collaborated with cross functional teams (principal investigators, neurosurgeons, physician assistants, coordinators, nonclinical lab personnel) to coordinate various investigator initiated clinical trials for brain cancer.• Oversaw conduct of clinical trial and recorded results data.• Documented and reported to the FDA serious adverse events and SUSARs, monitored lab results for flags.• Coordinated study plan with investigator.• Management of lost to follow-up and long term survival follow-up.• Maintained study results database.• Trained new personnel.

• Experience with medical device, drugs, biologics, and blood products/artificial blood products.• Collaborated with cross functional team of surgeons, anesthesiologists, operation room and recovery nurses, pharmacists, and principal investigators to facilitate the conduct of the clinical trial.• Oversaw recruitment, eligibility based on protocol inclusion/exclusion criteria, and informed consent of study participants for sponsor initiated and investigator initiated clinical trials.• Collected and recorded study data from Clinical Outcome Assessments, Patient Reported Outcomes, and health records (manual and electronic).• Completed case report forms and source documentation.• Maintained investigator site files.• Collected biospecimens per protocol, stored and shipped to labs (local and central).• Prepared investigational product for administration or use, set up computer systems to record study data.• Worked together with device or drug company sponsor representatives.• Facilitated compliant research procedures per GCP guidelines.• Prepared presentation materials for investigator.• Conducted follow-up with study participants and investigations into lost to follow up.• Sent applicable documentation to IRB (informed consent forms, safety letters, etc.).• Supervised, interviewed, and trained new clinical research coordinators.• Participated in FDA site inspections (data audit for sponsor regulatory submission).

• Experience in food as drug study• Monitored subject compliance and recorded deviations• Analyzed dietary logs and recorded data in database• Assisted in consenting subjects