Clinical Research Nurse Manager

Mariko Tsuruta, BSN, RN

Clinical Research Nurse Manager

**********@*****.*** • 740-***-****

LinkedIn URL • Rockville, MD, 20852

Hardworking RN with over 10 years’ experience. Currently managing and monitoring clinical trials on site using thorough knowledge of study protocols and related procedures as a Clinical Research Nurse Manager. Seeking a CRA position to leverage leadership and monitoring skills. Dedicated to the accurate, timely, and economical completion of clinical trials. Qualifications Summary

• Competent in establishing and maintaining sound clinical and data collection practices to ensure the validity of clinical research trials.

• Exceptional talent for monitoring the progress of clinical trials to ensure compliance with established protocols, appropriate research methodology, and trial timelines.

• Skilled in protocol development, site/investigator selection, trial initiation and termination activities. Experienced in developing and completing final trial reports.

• Demonstrated excellent understanding and application of ICH, GCPs, applicable regulations, and procedural documents to promote research validity, reliability, and efficiency.

• Competent at supervising and training employees, while organizing, prioritizing, and scheduling work assignments.

• Detail-oriented with a sense of diligence.

• Able to manage multi-task assignments within team-oriented environments by remaining flexible and adaptable in a wide range of scenarios.

Core Competencies

Clinical Trial Management Research & Development (R&D) Case Report Forms Research Team Operations Progress Monitoring & Closeout Visits Data Collation & Analysis Reporting & Documentation Participant Recruitment

Quality Control Project Management Team Leadership Complex Problem Resolution ICH, GCP, & FDA Regulations Electronic Data Capture (EDC) Standard Operating Procedures (SOP) Project Management Career Experience

Clinical Research Nurse Manager – Pharmaron CPC, Baltimore MD July 2020– Present Served as a clinical operations departmental lead recruiter and developed team diversity by securing top talent. Coached team members to complete assigned tasks independently and in close coordination with cross-functional units. Evaluated team dynamics and resolved complex issues. Ensured study completion with attention to quality, efficiency, and accuracy in line with set ICH/GCP guidelines. Executed nursing-specific protocol tasks to protect trial subjects. Monitor and document all A/E's, SAEs, medical histories, and responses to treatment. Engaged with PI, Sub-I's, physicians, project managers, research coordinator, staff nurses, and research assistants as well as other departmental members to ensure timely completion of research projects.

• Promoted to Clinical Research Nurse Manager in July 2021 based on exemplary performance.

• Re-built clinical research team almost from scratch through consistency, selection, motivation, and development.

• Conducted trial-related tasks and procedures, including investigational product (IP) administration, phlebotomy, sample collections, IV placement, obtaining vital signs, and ECGs.

• Exercised GCPs and Pharmaron CPC’s Standard Operating Procedures (SOPs), while performing research activities and the execution of Phase I-IIIb clinical trials.

• Led cross-departmental collaboration with heads to streamline existing processes related to information transfer to attain collective targets.

P a g e 2 2

Registered Nurse – Adventist Healthcare, Shady Grove, Rockville, MD July 2016 – October 2019 Delivered vital support and treatment to patients diagnosed with various acute illnesses on a Med-Surge Unit. Played a key role in communicating and coordinating patient care with the patient family, and internal teams.

• Rendered expert-level support to skilled nurses for the execution of day-to-day tasks.

• Utilized critical thinking skills, clinical knowledge, and established criteria to create viable/effective patient care plans.

• Contributed significantly towards the creation of a stress-free and quality-focused environment for patients. Registered Nurse – Johns Hopkins Bayview Medical Center, Rockville, MD March 2014 – July 2016 Served as a unit floats nurse for several areas in the hospital. Assisted staff in the ventilator and respiratory units, rehab, and medical behavioral unit.

• Defined complex treatment plans and medical procedures in a compassionate, simplified, and professional way.

• Developed an excellent rapport with families, caregivers, physicians, and other service providers by leveraging interpersonal skills.

Education

Bachelor of Science in Nursing, Wheeling University, Wheeling, WV, May 2011 Honors & Awards

Received Award Letter and commended by leadership team in 2022 based on exemplary performance. Licenses & Certifications

The CRA Training Institute – Online program certificate expected May 2023 RN Maryland Compact License expires in April 2025

Basic Life Support expires in February 2024

Advanced Cardiac Life Support, expires in February 2024 Harvard Business School – Certificate in Leadership and Management obtained January 2022 Electronic Health Records (EHR) Systems: Epic, MEDITECH, Cerner Languages

Japanese Native fluent in reading, writing, and speaking. American English – Full Professional Proficiency ILR – 4/CEFR – C2

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