· Performed site selection, initiation, interim, and closeout visits (onsite and remote) in accordance with protocol requirements and good clinical practice. Achieved 7+ DOS/month on average in-line with resourcing expectations. Conducted a cumulative of 150+ site visits and 250+ DOS over lifetime of CRA career.· Evaluated the quality and integrity of study site processes through the conduct of source data review, including evaluation of site’s compliance with protocol requirements & Sponsor SOPs, local regulatory requirements, and ICH-GCP principles.· Drafted regular visit reports & follow-up letters to adequately document monitoring visit activities/findings and associated action plans. Collaborated with clinical trial leads/report reviewers to achieve an on-time submission & finalization rate of 98% for all monitoring visit reports in 2023, surpassing the departmental goal of >95%.· Established standing lines of communication with site staff to manage ongoing project expectations and issues, including active management and closure of action items opened as a result of monitoring activities. Closed 98.2% of AIs within 90 days of opening in 2023, surpassing departmental goal of 95%. · Administered protocol and other study/system trainings to site staff personnel, particularly in the context of SIVs; evaluated and confirmed site staff qualifications.· Conducted IP accountability, accurately tracking and reconciling all IP stock through the lifecycle of receipt, storage, dispensation, and return/destruction.cont. below

cont. above· Conducted continuous site management activities to ensure the ongoing performance of sites, including adequate safety reporting, regulatory submissions & approvals, site recruitment strategies, periodic site contacts per study monitoring plans, and (CRF) completion & data query resolution.· Conducted periodic ISF and eTMF reviews, ensuring audit-readiness for trial-related regulatory documentation. Achieved an 84% eTMF completion rate for all assigned sites in 2023, surpassing departmental goal of >80%. Successfully conducted an eTMF lock for 1 study, meeting target deadline of mid-Feb2024.

· Achieved an 89% site selection rate compared to the target of 38% on a schizophrenia study with a key customer. In collaboration with a cross-functional team, developed a strategy for site outreach to maximize response by identifying high-potential investigators using 10+ site-specific metrics.· Presented updates (2x/week) to a customer for an under-performing project in high escalation (Sr. Director level), fielding difficult questions and preserving good relations with the account.· Developed relationships with 5+ key CNS accounts with multiple investigators in their network, driving new business.

· Delivered overhaul of departmental training plan for 40+ personnel in Q1 2019, achieving target timeline. ---· Identified needs and areas of improvement via feedback and interpersonal communication. ---· Delegated project tasks to 5, two-person teams and served in an oversight role to ensure delivery.· Worked with legal teams to review confidentiality language.

· Served as a point of contact and regulatory expert for 70+ clinical trials sites, ensuring GCP compliance.· Followed SOPs and WIs to ensure a consistent, quality deliverable; routinely referenced SOPs when a process was ambiguous.· Proactively reviewed site files (TMF) for completeness and accuracy to ensure audit-readiness in real-time. · Maintained ~95% TMF completeness and routinely resolved 50+ action items on a weekly basis.· Cultivated positive relationships with 70+ sites via the common goal of improved patient outcomes.· Developed project timelines (weekly to quarterly); executed effective follow-up involving all necessary stakeholders.· Developed a deep understanding of the clinical trial and drug development process with a focus on maintenance.· Managed competing priorities for multiple studies (3+), developing prioritization and time management skills.· Mentored new employees (5+) and conducted trainings on job processes.

· Followed through on an independent research project’s completion with minimal supervision.· Analyzed and interpreted results from data collection and determined effective future directions for projects.· Asked novel and interesting research questions in a small (10+) team-based setting.· Developed proficiency with RStudio (20+ hours) and applied it to relevant biological problems.

· Worked closely with PhD candidates, assisting with the completion of a semester-long project.· Developed writing, speaking and presentation skills to translate dense scientific findings into more accessible language (3, 30minute presentations with an audience of 20+)

· Developed interpersonal communication and customer-service skills via 10+ customer interactions per shift.· Utilized Dewey Decimal system, maintaining library organization.