Virtual Senior Research Coordinator, RN
Demonstrated experience with Phase I-IV Clinical Trial Coordination.
Demonstrated experience with Decentralized Clinical Trials (DCT).
Demonstrated experience with Patient Recruitment & Enrollment.
Demonstrated experience with Eligibility Screening.
Demonstrated experience with EDC & Source Data Verification (SDV).
Virtual Senior Research Coordinator, RN open to new opportunities
Managed 30+ Phase II-III clinical trials across multiple therapeutic areas, supporting study sites, sponsors, and principal investigators in a high-volume virtual research environment.. Identified prospective participants through structured outreach and recruitment workflows, strengthening enrollment pipelines across active study sites.. Evaluated patient eligibility against protocol-specific inclusion/exclusion criteria using medical record review, telehealth visits, phone screening, and digital communication.. Performed EDC entry and source data verification across concurrent trials, confirming alignment between source documentation and case report forms in accordance with ICH-GCP standards.. Coordinated communication among investigators, participants, and site teams to support protocol adherence, timely study execution, and responsive issue escalation.. Developed staff training materials and SOP documentation covering regulatory standards, quality assurance, regulatory compliance, and protocol-specific procedures.
Delivered daily acute and preventive nursing services for school-aged children in compliance with Pennsylvania Department of Education standards.. Developed individualized care plans for students with ADHD, asthma, diabetes, and food allergies and provided targeted student/parent education.. Maintained compliance with Section 504, FERPA, and IDEA requirements while supporting student health protections and accommodations.. Completed mandated health activities including physical exam review, immunization verification, vision screening, and biometric documentation.
Provided on-call nursing coverage across multiple school districts, summer camps, and clinic settings, adapting quickly to varied patient populations and institutional protocols.. Administered first aid, medications, and health screenings based on presenting needs and provider orders.. Connected families, students, and interdisciplinary support staff including educators, aides, speech therapists, occupational therapists, and physical therapists to facilitate coordinated care.
Applied American Sign Language to deliver culturally competent nursing care to Deaf and Hard of Hearing students across all grade levels.. Provided first aid and routine health services to students ranging from preschool through high school, with care tailored to individual developmental and medical needs.. Maintained accurate student health records and conducted required screenings in compliance with PDE regulations and institutional reporting standards.. Partnered with audiology, education, PT, OT, and speech pathology teams to support integrated student care planning.
Delivered skilled nursing to medically complex patients in home settings, including tracheostomy management, parenteral nutrition, and medication administration under DHS oversight.. Performed clinical duties within applicable state and federal regulatory requirements and DHS oversight.. Customized care delivery to patient health needs and functional limitations while promoting safety, dignity, and autonomy.
Conducted in-home developmental evaluations for infants ages 0-12 months across Lehigh County using the Battelle Developmental Inventory.. Produced detailed evaluation reports with clinical findings, developmental outcomes, and recommendations submitted to Pelican and PaTTAN tracking systems.. Applied evidence-based clinical practice to developmental recommendations supporting age-appropriate milestones.. Administered physician-ordered treatments including medication management, G-tube feeding, and seizure precautions in home settings.
Coordinated 5-10 global delegates to maintain pharmacovigilance program alignment across the product lifecycle.. Reconciled PV system records against internal quality standards, regulatory requirements, and compliance policies.. Supported stakeholder communication, documentation management, regulatory obligation tracking, and audit readiness.. Prepared meeting agendas, minutes, and action items to enable cross-functional decision-making and follow-through.
Supported Phase I developmental therapeutics trials in hepatic, renal, and pancreatic oncology, coordinating protocol-required activities across patient visits.. Managed study assessments, investigational drug administration, biological sample collection, and follow-up according to protocol schedules of events.. Tracked and documented adverse events with timely escalation to investigators to support patient safety.. Coordinated SIV activities, EDC entry, and protocol schedules to maintain sponsor and study compliance.
Coordinated 5+ Phase II-IV clinical trials simultaneously, including start-up, feasibility review, IRB submissions, monitoring visits, and closeout.. Supported pediatric rare disease, infectious disease, maternal-fetal medicine, and cardiovascular research programs.. Maintained and reconciled trial master files to support continuous readiness for sponsor monitoring and regulatory inspection.. Managed study data in CTMS, Medidata Rave, and REDCap, supporting data accuracy and timely query resolution.. Maintained GCP, FDA, and protocol compliance through CITI training, institutional policy review, and sponsor education.