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 collected, either onsite or remotely.- Escalates site and trial related issues per PRA SOPs, until identified issues are resolved or closed.- Facilitates audits and audit resolution.- Implements and monitors clinical trials to ensure sponsor and investigator obligations are being metand are compliant with applicable local regulatory requirements and ICH-GCP guidelines.- Performs essential document site file reconciliation.- Communicates with investigative sites.- May be assigned to complex studies and/or sites.- Ensures all required training is completed and documented.- May serve as a resource for and interact with other functional areas to resolve site issues and facilitatetrial timelines.- Provides regular site status information to team members, trial management, and updates trialmanagement tools.- Provides leadership skills to assigned projects and within the Clinical Operations department.- Assesses IP accountability, dispensation, and compliance at the investigative sites.- May be assigned additional Clinical Operations tasks.- Completes monitoring activity documents as required by PRA SOPs or other contractual obligations.- Verifies Serious Adverse Event (SAE) reporting according to trial specifications and ICH-GCPguidelines.- Assesses the qualification of potential investigative sites, initiates clinical trials at investigative sites,instructs site personnel on the proper conduct of clinical trials, and close clinical trials at investigativesites.

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 trials to ensure sponsor and investigator obligations were beingmet.- Served as an observation and performance visit leader.- Provided regular site status information to team members, trial management, and updated trial management tools.- Performed source document verification and query resolution.- Served as a resource for new employess.- Monitored clinical trials to ensure sponsor and investigator obligations were compliant with regulatoryrequirements and ICH/GCP guidelines.- Escalated site and trial related issues per PRA SOPs, until identified issues were resolved or closed.- Facilitated audits and audit resolution.- Worked closely with other clinical team members to facilitate timely resolution of trial and/or clinicalissues.- Ensured all required training was completed and documented.- Performed essential site file reconciliation.- Assessed IP accountability, dispensation, and compliance at the investigative sites.- Assessed the qualification of potential investigative sites, initiated clinical trials at investigative sites,instructed site personnel on the proper conduct of clinical trials, and closed clinical trials atinvestigative sites.- Completed monitoring activity documents as required by PRA SOPs or other contractual obligations.- Updated applicable tracking systems.

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 status information to team members, trial management, and updated trialmanagement tools.- Performed source document verification and query resolution.- Facilitated audits and audit resolution.- Reviewed and verified accuracy of clinical trial data collected, either onsite or remotely.- Performed essential site file reconciliation.- Updated applicable tracking systems.- Implemented and monitored clinical trials to ensure sponsor and investigator obligations were beingmet.- Escalated site and trial related issues per PRA SOPs, until identified issues were resolved or closed.- Ensured all required training was completed and documented.- Assessed the qualification of potential investigative sites, initiated clinical trials at investigative sites,instructed site personnel on the proper conduct of clinical trials, and closed clinical trials atinvestigative sites.- Worked closely with other clinical team members to facilitate timely resolution of trial and/or clinicalissues.- Communicated with investigative sites.- Completed monitoring activity documents as required by PRA SOPs or other contractual obligations.

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 grant application and monitor grant expenses and budgetPrepare financial documents for study staff payment according to university guidelinesManage 24 participating study sites with approximately 70% travelGrant writing and development of further research projects in the Department of Family and Community MedicineDevelop SOPs for progressive muscle relaxation treatment delivery through device applicationTrack patient device usage, adherence, and maintenance Assists in preparation for audits and responsible for quality of site related documentation

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 records for regulatory, subject enrollment, and device accountability Constructed CRFs, ICFs, monitoring tools, prescreening logs, query tracking reportsDeveloped processes for set-up, use, and maintenance of the medical devicesExtensive chart review and source document verificationTrack device usage and adherence

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 guidelines Preparation and submission of IRB documents and regulatory documents Prepared full reviews, CRO applications, and consent forms Created tracking system to manage patient appointments Maintained a professional/courteous relationship with patients Worked in laboratory completing various tasks with human specimen

Master'S Of Public Health, Epidemiology

Ba, Psychology