Elizabeth Waterman

Regional Study Coordinator II

Ora Inc.

Andover, MA

08.2021 - Current

Currently working as a Study Coordinator at a CRO with an Ophthalmology Focus
Developed and maintained study timelines for multiple studies.
Organized and conducted meetings with internal stakeholders to discuss progress of studies.
Ensured compliance with Good Clinical Practices guidelines throughout all stages of clinical trials.
Collaborated with other departments to ensure accuracy of data collected from clinical sites.
Performed quality control checks on database entries prior to submission to the sponsor or regulatory authority.
Created reports summarizing patient recruitment activities, enrollment numbers, and adverse events.
Coordinated research site visits for sponsors and monitors by arranging travel logistics, scheduling meetings, compiling documentation for review sessions.
Provided training and guidance to research staff regarding protocol requirements and procedures for data collection and entry into electronic databases.
Reviewed patient medical records for completeness and accuracy according to protocol specifications.
Maintained close communication with project teams including investigators, CRAs, vendors and external partners regarding study milestones and timelines.
Monitored subject safety during trial period by collecting information on adverse events reported by subjects or healthcare professionals.
Conducted regular audits of source documents at investigative sites to ensure accuracy of data entered into system.
Participated in feasibility assessments at potential investigative sites in order to determine suitability for participation in a given study.
Responded promptly to inquiries from investigational sites pertaining to study-specific issues or questions.
Documented any changes made during a trial such as amendments or protocol deviations.
Assisted in preparation of submissions for Institutional Review Board approval process.
Served as primary contact between sponsor companies and investigators throughout each stage of the trial process.
Identified areas where operational improvements could be implemented within existing projects in order to increase efficiency and reduce costs.
Kept patient care protocols and clinical trial operations in compliance.
Collected, processed and delivered specimens from trial participants.
Adhered to standards in areas involving data collection, research protocols and regulatory reporting.
Collaborated with sponsors and investigators to carry out efficient and fully compliant research trials.
Assessed records of each patient, reviewed databases and checked referrals to locate potential research study participants.
Conducted screening interviews to determine eligibility of possible subjects.
Educated participants on studies and anticipated outcomes.