Mark S Miller Email & Phone Number

Rockville, Maryland

Initiates and facilitates discussions that support the strategic development, technicalmanagement, and evaluation of DCR’s international clinical research programs; providesorganizational leadership and clinical research expertise in establishing program objectives, goals, and timelines for strategic and operational plans. Establishes procedures to safeguard the quality and integrity of data; implements new orrevised policies and initiatives related to the pharmaceutical management of clinicalresearch trials; drives accountability for quality assurance/quality control and riskassessment reporting. Maintains current, up-to-date knowledge and understanding of clinical research policies,regulations, best practices, and compliance requirements necessary to facilitate NIAIDresearch. Advises on and serves as a coordinator for regulatory issues involving NIAID intramuraldomestic and international clinical trials, and provides oversight of monitoring policiesand procedures.Monitors clinical trials by reviewing site visits performed by contract organizations orperforms site visits to ensure that DCR sites are operating under the Guidelines forGood Clinical Practice, and by inspecting documentation to ensure that the investigatorsare performing the study in a manner that protects the rights, welfare, and safety of theparticipants involved and the integrity of the data, as written in the protocol, and incompliance with the approved protocol, all applicable regulations and guidelines. Designs or reviews monitoring plans; ensures that all clinical research trials areperformed under regulations and/or guidelines that are regarded by the regulatoryagencies as critical to the successful outcome of the study.

Rockville, Maryland, United States

Provide operational expertise in the oversight of clinical research, including identification and resolution of regulatory issues and day-to-day research management issues.Coordinate a complex rapid research response to high consequence emerging disease threats in resource-limited countries.Advise on and serve as a coordinator for regulatory issues involving NIAID intramural domestic and international clinical trials.Ensure that all clinical research trials are performed under regulations and/or guidelines that are regarded by the regulatory agencies as critical to the successful outcome of the study.

Olney, Maryland, United States

Inpatient Clinical/Staff Pharmacist, As-Needed: manages pharmacy operations and supervises 3 pharmacy technicians during evening shifts. Performs pharmaceutical care for 150-bed hospital using physician order entry involving antibiotic dosing, medication reconciliation program, and DoseEdge IV checking system.

Silver Spring, Maryland, United States

Provided leadership and managed professional staff that reviewed all significantly violative inspections that may result in compliance of enforcement relating to inspections of clinical investigators, sponsors, and institutional review boards. The branch also evaluates the evidence and risks and executes steps necessary to resolve the issue(s), such as regulatory actions, including Warning Letters, disqualifications, restrictions, etc.

Bethesda, Maryland, United States

Professional Development at Department of Research Programs. Research oversight activities include ensuring adherence to all state and federal statutes, regulations, and policies related to Human Subjects Protection and the ethical conduct of research. Institutional Review Board primary board member and Exempt Research Determinations official.

Silver Spring, Maryland, United States

Fraud Drugs Branch: provided authoritative guidance and consultation regarding inspections and investigations to ensure compliance, enforcement of regulation, and adherence to the Federal Food, Drug, and Cosmetic Act. Engaged in strategic, risk-based, enforcement activities to minimize consumer exposure to unsafe non-prescription and fraudulent drug products.

Silver Spring, Maryland, United States

Provided leadership, direction, expert technical advice, and support for human subject protection program activities coordinated by the Office of Chief Scientist for human subjects research conducted or supported by the FDA.

Silver Spring, Maryland, United States

Responsible for pharmacovigilance activities which included evaluating, interpreting, and analyzing pertinent adverse drug reaction cases from the FDA Adverse Events Reporting System and other data mining databases. Safety evaluation required the utilization of medical-scientific judgement in determining the adequacy of clinical documentation, the severity of adverse reactions, and possible causal relationship between the drug and event(s).

Doctor Of Pharmacy - Pharmd

Bachelor Of Science - Bs