Toni Magliulo

• Collaborated with C-suite, key stakeholders and fellow people managers to organize efficient operations and achieve demanding schedule targets, alignment and integration amongst departments and all of RWJBH campuses.

• Work with clinical operations team to ensure all clinical study activities are completed in accordance with applicable regulations and guidance and SOPs

• Manage study budgets and be able to provide accurate forecasting

• Develop and implement SOPs for clinical trials and related activities, as required

• Ensure compliance with all applicable regulatory standards related to clinical trials and interactions with physicians

• Develop and maintain professional relationships with academic and community-based study sites

• Interface with departments within and outside including Finance, Regulatory Affairs, Legal Affairs and Medical Affairs

• Manage staff and outside partners/service providers

• Advise and assist investigators, and study team personnel with protocol and consent form design, institutional policies, and ethical considerations.

• Facilitate collaborative and effective cross-functional working groups with offices of grants and contracts, clinical compliance, finance, legal affairs, and privacy.

• Oversee clinical trials; including industry-sponsored, federally funded, investigator-initiated, FDA regulated clinical trials, and student/resident/fellow projects.

• Provide guidance to investigators on Investigational Device Exemptions (IDEs), Humanitarian Device Exemptions (HDEs), Premarket Notification 510(Ks), and Investigational New Drug (IND) applications.

• Provided regulatory expertise and leadership to affiliates in numerous areas (e.g., FDA, GCP, ICH, HIPAA).

• Manage projects from affiliated sites including: Monmouth Medical Center Southern Campus, Robert Wood Johnson University Hospital Rahway, RWJBarnabas Health Behavioral Health Center, RWJBarnabas Health Institute for Prevention and Recovery

• Monitor and develop appropriate risk mitigation strategies and corrective action plans for non-compliant investigators and protocol violations.

• Perform quality assurance initiatives, and audits to ensure compliance with Office for Human Research Protection(OHRP), federal and state regulations, and institutional policies.

• Develop standard operating procedures (SOPs), best practices, and policies to streamline procedures.

• Certify that all aspects of a study design pertaining to the protection of human subjects, such as; recruitment, consent process, study procedures, and handling Protected Health Information, are clearly established within the study protocol and IRB application; and are in compliance with applicable

regulations and institutional guidelines prior to IRB approval.

• Ensure that all required documents for IRB approval of a research study are received for review, such as; FDA or Sponsor letters regarding IND or IDE, an adequately written Protocol, IRB approval or letters of support from collaborating entities, Investigator's Brochure, Investigational device descriptions, Informed consents, data collection forms, CV's, and GCP training verification.
• Provide guidance and support to principle investigators and/or study coordinators in resolving IRB contingent approvals.
• Prepare and/or revise informed consent documents, study recruitment materials, and subject materials as needed.
• Assist in periodic review and revision of IRB department SOPs to ensure accuracy with current FDA, OHRP, and Institutional guidelines.
• Facilitate IRB meeting time, location, and member accommodations.
• Prepare and distribute IRB meeting agendas and minutes.

• Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
• Collected data and followed research protocols, operations manuals, and case report form requirements.
• Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
• Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets.
• Gathered, processed, and shipped lab specimens.
• Maintained compliance with protocols covering patient care and clinical trial operations.
• Directed site initiation visits, establishing key partnerships with local healthcare providers to facilitate successful trial implementation.
• Trained new team members on essential clinical research protocols and procedures, promoting a culture of continuous learning.
• Prepared detailed informed consent documents to clearly communicate risks, benefits, expectations, rights and responsibilities related to participation in clinical trials.
• Coordinated with cross-functional teams to ensure timely completion of clinical trial milestones.
• Developed strong relationships with trial sponsors, ensuring ongoing collaboration and future project opportunities.
• Facilitated clear communication between principal investigators, sponsors, and study participants for seamless trial execution.
• Oversaw the management of investigational product supplies, ensuring appropriate storage conditions were maintained at all times for optimal efficacy during trials.
• Maintained compliance with regulatory guidelines through rigorous documentation and protocol adherence.
• Managed study budgets and resources to maximize return on investment while maintaining quality standards.
• Assessed patients'' eligibility criteria following strict adherence to inclusion/exclusion guidelines.

• Assist in monitoring, reporting, and maintaining information on clinical trials to assure compliance with federal regulations, protocol objectives, ethical standards, and institutional policies.
• Assist Research Nurse Coordinator and Academic Affairs / IRB Coordinator in all aspects of research activities.