• Provide full support including technical and scientific guidance to study site personnel to ensure consistency in interpretation and exchange of scientific information in clinical trials.• Assist the project team in the development of study-specific monitoring tools and other related documents as needed.• Prepare and perform on-site qualification, research implementation, interim reporting, and close-out monitoring visits to investigator sites.• Assist project managers in evaluating project viability and recruiting.• Review participant eligibility and consent documentation to help researchers achieve accurate and meaningful results.• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular on-time visit reports.• Achieved 100% enrollment 2 months before projected LPI in OAG study.

• Conducted initiation, monitoring, and closeout visits to verify study procedures, regulatory documents, and data completion.• Created several innovative ways to deliver accurate information and maintain the client specifications for each project.• Performed management of study site activities to ensure the integrity of clinical data, in adherence to all applicable regulatory guidelines.• Assisted team in the development of site recruitment and retention strategy.• Assisted project managers in evaluating project viability and recruiting.• Reviewed participant eligibility and consent documentation to help researchers achieve accurate and meaningful results.• Created and maintained appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports.

• Assisted in feasibility review and site selection process as appropriate.• Monitored and tracked investigator site performance utilizing various systems; escalated significant issues appropriately.• Assisted with development/review of study training materials and study management tools.• Assisted with the review and cleaning of clinical study data.• Assisted the clinical study team in coordinating investigator and study meetings including preparation, production, and distribution of materials.• Assisted project managers in evaluating project viability and recruiting.• Reviewed participant eligibility and consent documentation to help researchers achieve accurate and meaningful results.• Created & maintained appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports.• Achieved 100% enrollment 3.5 months prior to projected LPI in Parkinson’s Disease study.

• Independently coordinated complex (i.e., interventional, therapeutic greater than minimal risk) clinical research protocols with minimal direction from the principal investigator and supervisor in compliance with regulatory laws and institutional guidelines.• Collaborated with research team to assess feasibility and management of research protocols.• Ensured implementation of research protocols after IRB approval and provided information as appropriate for progress reports.• Screened, enrolled, and recruited research participants.• Coordinated schedules and monitored research activities and subject participation.• Identified, reviewed, and reported adverse events, protocol deviations, and other unanticipated problems appropriately.• Managed, monitored, and reported research data to maintain quality and compliance.• Provided education/training for others within the department.• Performed administrative and regulatory duties related to the study as appropriate.• Reviewed Board (IRB) document preparation and submission; and provided consultative expertise regarding regulatory and policy requirements.• Accurately applied investigators' scientific data into a cohesive format for the protocol document and associated procedures that were consistent with internal and external policies and regulatory requirements.• Participated in other protocol development activities and executed other assignments as warranted and assigned.• Primary assigned studies consistently met 100% of site’s projected enrollment within projected timelines.