Stephen Wells Email & Phone Number

Lexington, Kentucky, United States

- Serves as a preceptor for new CRAs participating in the CRA Bridge Program.- Mentors junior level CRAs and serves as a resource for new employees.- Serves as observation and performance visit leader.- Performs source document verification and query resolution. - Updates applicable tracking systems.- Reviews and verifies accuracy of clinical trial data.

Lexington, KY

- Served as a resource for and interact with other functional areas to resolve site issues and facilitate trialtimelines.- Reviewed and verified accuracy of clinical trial data collected, either onsite or remotely.- Verified Serious Adverse Event (SAE) reporting according to trial specifications and ICH-GCPguidelines.- Implemented and monitored clinical.

Regional

- Verified Serious Adverse Event (SAE) reporting according to trial specifications and ICH-GCPguidelines.- Monitored clinical trials to ensure sponsor and investigator obligations were compliant with regulatoryrequirements and ICH/GCP guidelines.- Assessed IP accountability, dispensation, and compliance at the investigative sites.- Provided regular site.

70% travel and in-houseLiaison for study sites while on-site communicating project information and answer questionsComplete site enrollment/management (site selection, initiation and monitoring)Participate in proposal meetings and negotiate study budgets with investigatorsMonitor recruitment and data quality remotely through communication with sitesManage.

60-70% travel & in-houseManaged 12 sites Executed site initiation, training, monitoring, and close-out activities Trained site personnel on protocol and study requirementsAssured site compliance with ICH-GCP guidelines, Investigational Plan, Monitoring Plan, and applicable regulatory documentsDeveloped SOPs, newsletters, and device manuals Monitored site.

Oversaw university, pharmaceutical, and medical device based projectsEnsured subject enrollment met schedule deadlinesDetermined enrollment eligibility and performed subject interviews Maintained source documents, CRFs, and device accountability logsResolved sponsor initiated data queries Reported serious adverse events according to IRB and sponsor.

Master'S Of Public Health, Epidemiology

Ba, Psychology