Kate Eident Email & Phone Number

Boston, Ma, Us

Boston, Massachusetts, Us

• In collaboration with sponsors, responsible for site selection and activation.• Oversees site operations while ensuring that all study activities are conducted following ICH/GCPguidelines, internal and sponsor SOPs, and other related regulatory requirements.• Responsible for the creation of study documents such as informed consent forms (ICFs), assent forms, recruitment materials, case report forms, and other study related documents.• Reviews and approves required regulatory documents; and works to ensure the study Trial Master File (TMF) is up to date and “audit ready” throughout the course of the study.• Manages IRB-related activities such as initial submissions, amendments, and continuing reviews.• Maximizes alignment of project goals and resources by collaborating cross-functionally with internal teams.• Directly mentors and manages all site management staff and other team members as applicable.

Boston, Ma, Us

• Prepares and study documents and protocol applications for submission to the IRB, SMART IRB system, sponsor or other regulatory authority.• Assists in planning and implementing clinical research studies for the entire Department of Newborn Medicine• Authors informed consent forms (ICFs), assent forms, protocols, recruitment documents and otherpatient-facing materials.• Oversees the collection, maintenance and retrieval of study data and develops/implements systems and procedures to ensure accuracy, consistency and conformance with study protocols• Assists in QC/QA reviews of current study documents such as subject folders and the ISF to help prepare for Sponsor monitoring visits or audits• Builds and maintains multiple REDCap databases

Chicago, Illinois, Us

• Recruits and obtains consent of research subjects, as appropriate to specific study protocol inclusion/exclusion criteria.• Schedules and runs study visits according as outlined in the protocol.• Participates in data quality control, monitoring visits and audits.• Maintains effective and ongoing communication with sponsor, CRO, research participants and PI during the course of the study.• Plans, implements, and maintains data collection systems in support of research protocols.• Documented laboratory data and adverse reactions with immediate notifications about serious adverse events.• Processes, packages, and ships laboratory samples per protocol and IATA guidelines.

Chicago, Il, Us

• Acted a liaison between physicians, clinical staff, the IRB office, grant sponsors and other regulatoryagencies to ensure resources are allocated appropriately across all projects.• Assisted with recruitment and enrollment strategies and analyzed retention rates.• Created and maintained patient database through OnCore.• Participated in the creation and development of patient metrics, questionnaires and recruitmentmaterials• Assisted PI with federal grant submissions• Responsible for any documents submitted to the IRB, DOD or other governmental or regulatoryagencies

Evanston, Il, Us

• Responsible for the creation, testing and maintenance of the EDC for multiple studies• Participated in the planning and conduct of research studies including participant recruitment,retention, protocol design, development of study documentation and data collection• Obtained informed consent and administered tests and/or questionnaires as outlined in the protocol.• Collected, recorded, reviewed and summarized research data.• Facilitates communication with key personnel and participants to maintain project study flow.• Prepares reports for investigators, sponsors, and safety boards on recruitment status and other pertinentstudy data.

Evanston, Il, Us