STEPHANIE BERRY

• Clinical monitoring strategy and compliance oversight.
• Site feasibility and selection.
• Development of trial-specific plans and documents.
• Regulatory submission support.
• Study initiation and greenlight activities.
• Monitoring Oversight Visits.
• Trial progress review and corrective actions.
• Managed clinical trial operations for innovative cancer therapies at Immatics.
• Coordinated cross-functional teams to ensure compliance with regulatory standards.
• Oversaw patient recruitment strategies to enhance trial enrollment efficiency.

Oversaw protocol and GCP deviations to uphold compliance as deviation manager.

Directed initiation and greenlight activities for studies, improving project efficiency.

• Facilitated startup and activation of 40 US sites for Phase 3 BLA study.

Cultivated strong site relationships, offering guidance to CRAs for enhanced performance.

Managed regulatory submissions and essential documents to streamline processes.

Engaged in continuous improvement initiatives to optimize operational workflows.

• Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned
• Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study
• Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements
• Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review
• Monitor data for missing or implausible data
• Ensure the resources of the sponsor and LabCorp are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to LabCorp travel policy
• Ensure audit readiness at the site level
• Prepare accurate and timely trip reports
• Manage small projects under direction of a Project Manager/Director as assigned
• Serve as lead monitor for a protocol or project and may assist in establishing monitoring plans and trip report review as assigned
• Review progress of projects and initiate appropriate actions to achieve target objectives
• Organize and make presentations at Investigator Meetings
• Participate in the development of protocols and Case Report Forms as assigned
• Participate in writing clinical trial reports as assigned
• Track and follow-up on Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
• Independently perform CRF review; query generation and resolution against established data review guidelines on Covance or client data management systems as assigned by management
• Assist with training, mentoring and development of new employees, e.g. co-monitoring
• Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable) and may act as a local client contact as assigned

• Selected and closed out suitable investigational sites for clinical trials.
• Monitored for data integrity, compliance with study protocols, SOPs, and applicable regulations at each site.
• Participated in additional areas of study management and staff training as necessary.
• Contributed insights during reviews of ICON systems to promote best practices.
• Served as a benchmark for monitoring competence among less experienced colleagues.
• Ensured alignment with ICH-GCP principles during all phases of site monitoring.

• Function as project lead (with project management and clinical research
associate responsibilities) for complex bioequivalence/phase 1 studies and patient PK/clinical endpoint studies.
• Provide oversight activities of Clinical Research Associates and monitor when these activities are contracted to Clinical Research Organizations (CRO).
• Assist in registration processes for clintrials.gov
• Serve as liaison between the project team, affiliate companies, and Clinical Research Organizations (CRO) regarding contract and budgetary
information, project timelines.
• Collaborate with clinical study site to troubleshoot and provide solutions to study-related issues. Identify and escalate critical issues per standard
procedures.
• Ensure the study conduct by the contracted CRO is compliant with
assigned study protocols, overall clinical objectives, GCP/ICH Guidelines, SOPs and applicable federal, state and local requirements.
• Develop Clinical Monitoring Plan to incorporate planned monitoring strategy and activities necessary as determined to mitigate potential risk
identified during the risk assessment.
• Conduct clinical monitoring of studies remotely and on-site as required
according to the Clinical Monitoring Plan (CMP).
• Review source documentation, case report forms, data entry guidelines,
clinical study reports, and regulatory documents for accuracy to ensure
subject safety and data integrity.
• Oversee and assist in training and mentoring of new Clinical Research
Associates

• Oversee standard and complex bioequivalence clinical research studies by ensuring the proper monitoring, completeness, timeliness and quality.
• Assist in monitoring Phase I First to File project with lead Clinical Research Associate to ensure condensed project timelines are achieved.
• Ensure Principal Investigator/study site are complaint with study protocol, clinical objectives, FDA, ICH and other regional guidelines and regulations, and internal SOPs.
• Maintain all required regulatory study documents, monitoring records and correspondence confidentially and in accordance with applicable document and control procedures for each project.
• Conduct clinical monitoring of studies remotely and on-site as required according to Standard Operating Procedures (SOPs) and Clinical Monitoring Plan

• Provided care and hemodynamic monitoring to critically ill, unstable patients with varying diseases and illnesses.
• Plan, manage, and assess care of patients.
• Administer and titrate medications to keep patients hemodynamically stable utilizing critical thinking skills.
• Manage patients who require ventilator assistance.
• Educate patients and families on the medical issues at hand.

• Provided care and hemodynamic monitoring to critically ill and unstable patients.
• Recovered patients in the immediate post-operative phase of coronary artery bypass graft surgery utilizing critical thinking to optimize their care.
• Monitoring and titrating cardiac drips to keep patients hemodynamically stable.
• Caring for patients who require ventilator and cardiac equipment support.

• Coordinated patient care by effectively implementing physicians' orders to ensure optimal treatment outcomes.
• Led floor team by supervising LPNs and Nursing Assistants, ensuring high standards of patient care and teamwork.
• Specialized in medical-surgical nursing, delivering comprehensive patient care in a hospital setting.