Kat S Email & Phone Number

Dublin, Ie

•Conducts an evaluation of the site to effectively handle and perform a clinical trial, both scientifically and professionally.•Tracks patient recruiting by contacting investigators as defined for the report and exploring possible risks and opportunities for the research.•Coordinates and monitors site monitoring tasks and activities.•Manages all facets of the clinical trial at all assigned clinical sites to ensure patient protection, comply with relevant safety standards and data integrity.•Scientifically monitors clinical trials, through the analysis of case report forms (CRFs) and source documentation, to ensure conformity with the procedure and accuracy and scientific validity of the data.•Appropriately resolves issues related to trial monitoring and management with guidance from Supervisor.•Responsible for the start-up, initiation, implementation, and management of clinical trials for the assigned sites.•Collaborates closely with the entire study team, including the medical Monitor, Project Manager, and the entire in-house study team to ensure the successful execution of the clinical study.

Dublin, Ie

•Developed and illustrated understanding and adapting expertise in the therapeutic area to assignments and project-related problems.•Provided site control and tracking assistance for sponsored clinical studies.•Appropriately resolved issues related to trial monitoring and management with guidance from Supervisor.•Responsible for the start-up, initiation, implementation, and management of clinical trials for the assigned sites.•Collaborated closely with the entire study team, including the medical Monitor, Project Manager, and the entire in-house study team to ensure the successful execution of the clinical study.•Conducted an evaluation of the site to effectively handle and perform a clinical trial, both scientifically and professionally.•Tracked patient recruiting by contacting investigators as defined for the report and exploring possible risks and opportunities for the research.•Coordinated and monitored site monitoring tasks and activities.•Managed all facets of the clinical trial at all assigned clinical sites to ensure patient protection, comply with relevant safety standards and data integrity.

Rahway, New Jersey, Us

•Conducted protocol management for an assigned set of multiple research protocols, orientation, screening and educational programs.•Maintained current and accurate protocol documentation and was aware of the timeliness of regulatory documents.•Compiled and submitted data on appropriate forms according to protocol requirements.•Identified and communicated important protocol and data management issues or problem areas to the supervisor.•Developed and illustrated understanding and adapting expertise in the therapeutic area to assignments and project-related problems.•Provided site control and tracking assistance for sponsored clinical studies.•Appropriately resolved issues related to trial monitoring and management with guidance from Supervisor.•Responsible for the start-up, initiation, implementation, and management of clinical trials for the assigned sites.

Houston, Tx, Us

•Coordinated clinical studies in the medical research area. Developed an understanding of the requirements of the study protocol and obtained necessary information from physicians and study participants and recorded this information appropriately.•Developed and maintained communication with the research manager, co-workers, principal investigators, and other internal personnel regarding study-related issues.•Prepared for and met with pharmaceutical monitors’ site visits. Maintained professional relationships with external customers.•Ensured all protocol-required procedures and visits occur according to specified guidelines.•Ensured that drug dispensing is performed according to the protocol, documented on inventory forms/electronic records, and maintained and updated regularly.•Responsible for all aspects of study termination, i.e., complete necessary documents/forms, the return of drugs to the drug company.