Mark Fritschlanski Email & Phone Number

Baltimore, Md, Us

Henry M. Jackson Foundation is a full-service non-profit research organization focused on delivering innovation to support the health of US armed forces members and their families. I was brought on to develop and integrate program policy, provide subject matter expertise in regulatory matters, and guide quality management activities for the Infectious Disease Clinical Research Program, which serves as the DoD’s primary research program on infectious disease. Highlights: • Developed and implemented an electronic Trial Master File system to achieve regulatory compliance across all IDCRP program activities.• Initiated an internal Quality Management program for all IDCRP protocols to deliver accurate data, facilitate results publication, and advance the scientific aims of IDCRP.• Achieved and maintained regulatory compliance across all active protocols (20+). Led core and site regulatory teams and set policy and compliance mechanisms.

Emmes is a global CRO, providing full-scope clinical research to industry, academic, and government clients. I joined Emmes as a CRA and held both Study Manager and CRA roles for ~100 studies across multiple indications (e.g. oncology, infectious disease, neurology, psychiatry) and product types (e.g. prophylactic and therapeutic vaccines, small molecule drugs, monoclonal antibodies, devices, behavioral modalities). Highlights: • Managed budgets of up to $4.6mm.• Tracked milestones using project management tools (e.g. Asana, Microsoft Project, Smartsheet) and research industry software (e.g. Veeva Vault, Florence, REDCap, Medrio, iMedidata).• Guided efforts of project teams with up to 12 direct reports and 65 overall members. • Earned promotion to Senior CRA role and served as sole CRA for all FDA-sponsored studies.

CCRA conducted clinical research studies on depression & anxiety, bipolar disorder, ADHD, and other health disorders. Performed hands-on patient care before promotion to leadership roles for ~15 studies. In this role I served as the Clinical Research Coordinator for depression, bipolar, addiction, anxiety, and PTSD protocols, with direct patient contact as lead study CRC.

Bachelor Of Arts - Ba, Psychology

Education record

Education record