Youssef Arman

About Youssef Arman

Experienced Clinical Research Associate with a demonstrated history of working in the pharmaceuticals industry. Skilled in Microsoft Word, Good Clinical Practice (GCP), Leadership, U.S. Food and Drug Administration (FDA), and Microsoft Excel. Strong research professional with a Bachelor\'s degree focused in Biology/Biological Sciences, General from Georgia State University.

Experience

1. Csa (Clinical Site Ambassador)

   Advanced Clinical

   Jul 2022 — Present · Atlanta, GA, US

   Perform Investigator feasibility and capability assessments to support site evaluation in the appropriate country.•Serve as single point of contact with the site to collect/review site documents and ensure quality/accuracy of documents in accordance to ICH/GCP and local regulations, requirements, and guidelines.•Support contract/budget negotiations and payment processes.•Review and/or input to study protocol, CRF, and validation tools.•Assist in the preparation and participate in investigators meetings.•Conduct site qualification visits (pre-study visits), site initiation visits, interim site visits, and site close out visits, in accordance to SOPs, ICH/GCP.•Coordinate between site and appropriate contacts to ensures the site is equipped with all necessary supplies to perform study procedure and sites have all applicable study required accesses.•Perform source document verification, source data review, review regulatory documents and investigational product, and prepare trip reports as outlined in the Monitoring Plan to ensure data quality of assigned sites.•Communicate to the site and follow-up/resolve all site questions, issues, and concerns.Verify site visits are scheduled and conducted in accordance to the Clinical Monitoring Plan (schedule and activities).•Maintain awareness of key study-performance indicators for assigned sites including subject recruitment and retention strategies.•Escalate to the study team (Lead CSA) any site status, issues, etc.•Serve as single point of contact for communications with all site staff.•Manage IP accountability, proper maintenance of IP processes, and documentation at the site•Conduct co-monitoring visits and/or mentoring.•Evaluate the Investigator Site File (ISF) for accuracy, timeliness, and completeness.•Reconcile the ISF with the Trial Master File (TMF) to ensure audit readiness, including filing of all applicable documents.

Education

• Georgia State University

  Bachelor's degree, Biology/Biological Sciences, General

  2006 — 2009