Montserrat Robledo Ruvalcaba

· Coordinate day-to-day operations for 7 active clinical research studies within urogynecology and geriatric patient populations.

· Recruit, screen, consent, and enroll study participants across multiple clinical sites, including Winston-Salem, Greensboro, High Point, and Lexington clinics.

· Successfully enrolled approximately 130 participants while supporting study recruitment goals and participant retention efforts across concurrent protocols.

· Present and obtain informed consent while educating participants regarding study procedures, risks, benefits, and participation requirements.

· Review medical records and conduct protocol-specific eligibility assessments to identify qualified research participants.

· Utilize REDCap, Epic, OnCore, and Captivate Live to manage participant tracking, study documentation, scheduling, and data management activities.

· Collaborate with principal investigators, study sponsors, CROs, monitors, regulatory personnel, and multidisciplinary healthcare teams to ensure protocol compliance and study success.

· Monitor enrollment performance and identify opportunities to improve recruitment and participant engagement across multiple sites.

· Participate in sponsor study startup activities, Site Initiation Visits (SIVs), Interim Monitoring Visits (IMVs), and study closeout visits.

· Maintain regulatory documentation and contribute to reportable event submissions while ensuring compliance with IRB, GCP, and institutional requirements.

· Assist with staff training, onboarding, and mentoring of research support personnel and volunteers on study procedures and participant interactions.

· Authored a complete research protocol, including study objectives, methodology, recruitment strategies, data collection procedures, and statistical considerations.

· Prepared and submitted IRB application materials and successfully obtained approval for human subjects research.

· Developed study documents, participant material, and data collection tool to support research implementation.

· Gained experience in study startup, regulatory compliance, participant recruitment planning, and research project management.

· Conducted extensive literature reviews to identify a clinically relevant research question addressing a gap in current evidence.

· Assisted with manuscript preparation and scientific writing activities for dissemination of research findings.

· Implemented individualized behavioral intervention plans for pediatric clients using principles of Applied Behavior Analysis (ABA).

· Collected, documented, and analyzed behavioral data to evaluate treatment effectiveness and support clinical decision-making.

· Collaborated with behavior analysts, caregivers, and multidisciplinary healthcare teams to support client progress and treatment goals.

· Provided direct patient care in long-term care, rehabilitation, and healthcare settings while maintaining HIPAA compliance.

· Monitored and documented vital signs, patient status changes, and activities of daily living.

· Collaborated with nurses and other healthcare professionals to support safe, high-quality patient care.