Alyssa Smith

Identify, select, initiate, and close-out appropriate investigational sites for clinical studies. To monitor those sites in order to ensure that studies are carried out according to the study protocol and in accordance with ICON SOPs/WPs, applicable regulations and the principles of ICH-GCP.

Provide support to sites and CRAs directly to process and resolve queries and requests as needed. Serve as primary in-house contact for sites and investigators participating in studies. Become familiar with the principles of and assist with investigator recruitment. Conduct and complete remote site management activities, with support as needed, according to applicable SOPs and the Study Monitoring Plan. Contact clinical sites for specific requests, including enrollment updates, missing documentation, data entry timeliness, data query follow-up, CDA finding follow-up, and action item resolution or other sponsor-specific tasks.

Provide support to healthcare providers, clinical research nurses, and ancillary departments to assure care is provided per protocol standards. Evaluate medical records to ascertain patient information on performance status, response to investigational treatment, and Severity of Toxicities based on protocol requirements. Coordinate with study sponsors to answer queries and act as liaison to the clinical team. Recognize and report adverse events. Independently evaluate potential research study protocols for feasibility.

Manage samples coming into Progenity via Clinical Protocols. Perform data entry into freezer management software. Adhere to quality control guidelines to ensure integrity of laboratory specimens and accurate data entry. Perform data entry into freezer management software.

Manage all samples coming into Progenity via Clinical Protocols. Adhere to quality control guidelines to ensure integrity of laboratory specimens and accurate data entry. Functioned as Study Coordinator on various occasions (Set up blood draws and enrolled subjects into ongoing studies). Responsible for regular and ad hoc reporting on sample inventory. Write Laboratory sample processing SOPs and Procedures. Assist in Project Validations in terms of sample requirements and blinding efforts.