Juozas (Joe) Gurevicius Email & Phone Number

Chicago, Il, Us

- Serve as main CTI contact for assigned study sites- Conduct site visits (pre-study [PSV], site initiation [SIV], interim monitoring [IMV], and close-out [COV]) and complete site visit deliverables with quality and within given timelines in Monitoring Plan while adhering to all applicable regulatory requirements, SOPs, and ICH GCP- Assist with study start-up activities, including feasibility, pre-study activities and site selection- Collect, review, and track essential/regulatory documents- Participate in investigator, client, and project team meetings- Assist in developing patient enrollment strategies with Project Team and study sites- Ensure proper storage, dispensation, and accountability of all Investigational Product (IP) and trial-related materials- Perform site management activities and provide ongoing updates of site status to Clinical Project Manager- Conduct remote monitoring and complete all the related activities in accordance with study specific Monitoring Plan- Utilize systems and reports to track subject status, subject case report form (CRF) retrieval / source document review (SDV), regulatory documents, and IP- Assist with project-specific activities as member of Project Team- May support in development of CRFs and other study related documents (subject worksheets, Monitoring Plan, etc.)- Where applicable, provide support to Regulatory Affairs Study Start-up Team in the preparation or revision of documentation for submission to Ethics Committee(s), Institutions Ethics Committees, Regulatory Authorities, Competent Authorities or Institutions Administration Boards, and follow-up the evaluation process until approval is available. Provide regular updates to Sponsor/Client- Manage ISF and TMF for all assigned study sites in accordance with SOPs or study-specific Monitoring Plans- Identify site issues and implement corrective actions or escalate as appropriate- Liaise with Clinical Data Management for data cleaning activities

Covington, Kentucky, United States

- Performed in-house monitoring activity related to clinical trials while adhering to all applicable regulatory and SOPs- Performed on-site clinical trial monitoring, co-monitoring, and close-out activities, with oversight fromproject CRAs when required, while adhering to all applicable regulatory requirements and SOPs- Conducted independent on-site monitoring as sponsor requirements allowed- Assisted project teams with study start-up activities, including site selection and phone Pre-Study Visits to identify and evaluate potential investigative sites- Collected, reviewed, filed, and tracked regulatory documents for investigative sites, when required,including assisting the project CRA with reconciliation of the TMF/eTMF- Participated in or conduct study specific training for CTI personnel or investigative sites- Attended Investigator or sponsor meetings- Assisted in development of monitoring tools for study, including remote monitoring checklist for eCRF studies- Conducted routine remote monitoring of eCRF studies, issuing queries in the database- Compiled monitoring visit packets and provided to project CRAs prior to on-site monitoring visits- Assisted in maintaining project-related tracking for CRA visit reports and letters, protocol deviations, serious adverse events (SAEs), and IND Safety reports- Contacted sites to ensure proper completion of monitoring / data management queries within timelines, resolution of action items related to Interim Monitoring Visits, and other site management tasks- Served as support / contact for CRA Team questions- Assisted with project-specific administrative activities as member of project team- Increased knowledge of drug development process, therapeutic areas, ICH / GCP, and any applicable local regulatory requirements

Covington, Kentucky, United States

- Assisted in organizing, composing, and producing professional letters, summaries, reports, minutes, etc., using Microsoft Office software including Word, Access, and Excel- Proofread documents ensuring grammar, spelling, and punctuation are correct- Assisted in developing capability and training presentations using PowerPoint- Sent open query reports, enrollment updates, and all site correspondences- Assisted with TMF reconciliation of monitoring and training documents- Created professional binders for distribution to clients- Assisted in developing corporate overviews- Assisted in developing study newsletters- Performed research and summarize articles on companies or products- Assisted in data entry, filing, and front desk/phone coverage- Assisted with manual randomizations- Processed documents in the eTMF as a member of the Document Processing Center team- Assisted with any other duties as assigned by supervisor

Deerfield, Illinois

•Entered and verified over 200 motor diaries and lab normal ranges, and completed adverse event checks for 12 studies. •Utilized a Clinical Research Associate (CRA) training course offered by Advanced Clinical.

Hinsdale Il

•Taught players ages 5-18.•Helped run group sessions for highly competitive tennis players.•Taught private lessons that concentrated on skill development.•Provided administrative support to the program by speaking with clients and instructing players.

Hinsdale, Il

•Taught players ages 5-18.•Helped run group sessions for highly competitive tennis players.•Taught private lessons that concentrated on skill development.•Provided administrative support to the program by speaking with clients and instructing players.