Danielle Gann, Acrp-Cp Email & Phone Number

Morrisville, Nc, Us

Since 2021, I have been working at Premier Research, balancing remote and on-site work from Belton, TX. My role involves leading internal Site ID Kick-Off Meetings (KOM) with project teams, including Clinical Strategy Leads and Medical Informatics, to ensure we are all aligned before study initiation. I am deeply involved in site selection, working with clinical, regulatory, and project management teams to confirm that each site meets compliance standards and aligns with the feasibility assessments.Key Contributions:★ Collaborated with internal teams and external vendors to finalize projects within contractual timeframes, thereby raising client satisfaction.★ Accomplished Phase I/II global feasibility for high-priority oncology study, completing all site selections in less than 90 days in January 2024★ Directed site outreach for post-award, standalone paid feasibility, and pre-award blinded site activities, providing oversight to team of 25 site startup associates and maintaining alignment with study timelines.★ Served as secondary point of contact for site-related queries and issues, facilitating seamless communication between sites, clients, and internal teams, thus minimizing delays during site identification.★ Developed and delivered site identification presentations to internal and external audiences, promoting clarity and engagement during study-specific discussions.Site Identification & Study Management:★ Advanced site identification activities using CTMS, adhering to tight study timelines, and validating data accuracy through precise tracking and documentation.★ Leveraged historical performance metrics, Medical Informatics data, and site clusters to identify and prioritize potential sites, elevating quality of site selection.★ Designed and administered Site Recruitment Questionnaire (SRQ) process, achieving high completion rates and selecting sites that met study-specific requirements.

Prior to Premier Research, I spent five years with IQVIA Biotech, working my way up from a Site Feasibility Specialist to a Senior Site Feasibility Specialist. I was responsible for facilitating the negotiation and review of Informed Consent Forms (ICFs),ensuring they met stakeholder expectations and helping sites secure timely approvals. Additionally, I managed a team of global SSU specialists, coordinating regulatory document oversight that was crucial for the successful launch of study activities.Key Contributions:★ Transitioned from startup-focused roles to leadership position in feasibility, driving strategic initiatives that improved efficiency of SSU function.★ Achieved 50% reduction in initial time to open for complex oncology study in December 2017, significantly accelerating patient recruitment and study timelines.★ Guided global feasibility efforts, adapting strategies during pandemic (2020 to 2021) to maintain project momentum, realizing consistent study startup success.★ Directed site outreach for feasibility activities, leading team of site feasibility associates and promoting targeted approach to site selection based on project needs.★ Orchestrated weekly client teleconferences and internal team meetings, providing up-to-date status reports that enhanced transparency and client satisfaction.★ Collaborated with sponsors, clinical teams, and contract departments to prioritize site activations, guaranteeing strategic alignment across all project phases.Study-Specific Expertise:★ Supported sites with local IRB/ethics committee submissions, reducing submission delays and facilitating smoother approvals.★ Resolved regulatory issues by engaging directly with sites or local CRAs before IRB/ethics committee submissions, maintaining momentum in startup phase.★ Communicated study progress, challenges, and updates to Project Managers and ISSC Management, ensuring adherence to timelines and swift resolution of obstacles.

Wilmington, Nc, Us

In 2015-2016, I joined PPD, Inc. as a Country Approval Specialist (CAS), where I engaged directly with investigators, assisting them with ethical and regulatory submissions. Acting as the main contact at the country level, I contributed significantly to achieving PPD’s target cycle times by compiling regulatory compliance packages and collaborating closely with Site Initiation Associates.Key Contributions:★ Prepared and reviewed local regulatory submissions, including Ministry of Health (MoH) and Ethics Committee (EC) applications, aligning with global submission strategies for timely approvals.★ Coordinated with internal departments to synchronize site startup activities with regulatory submission processes, achieving smooth alignment with critical path timelines.

Winston-Salem, Nc, Us

Here, I managed site-level operations for Phase II-IV trials, ensuring data accuracy and adherence to sponsor protocols, FDA regulations, and ICH/GCP guidelines. Also, I led cardiology research activities as Lead Cardiology Research Coordinator, overseeing study workflow, maintaining protocol adherence, and guiding my team in cardiology studies.Key Contributions:★ Recruited and educated study participants across various therapeutic areas, including cardiology, endocrinology, gastroenterology, internal medicine, pulmonary, rheumatology, vaccines, and orthopedics.★ Executed sponsor-required procedures, such as electrocardiogram tracings, phlebotomy, blood processing, and vital sign assessments, confirming study protocol adherence.★ Controlled inventory of study drugs, placebo, and devices, ensuring proper dispensing, collection, and accountability in line with protocol requirements.★ Monitored study progress and maintained ongoing communication with participants, promptly identifying and reporting adverse events for participant safety.★ Created study-specific documents, including recruitment plans and source documents, and maintained regulatory binders for accurate documentation.★ Coordinated with sponsors, CROs, IRBs, and investigators, elevating collaboration across study teams.★ Assisted in training new study coordinators and represented site at Investigator Meetings, encouraging knowledge sharing and study continuity

Wilmington, Nc, Us

In this role as a Procedures Education Nurse, I triaged cardiac patients via phone and in-office assessments, providing thorough clinical evaluations. I also educated patients on the risks, benefits, and processes of various cardiac procedures, which helped them prepare more confidently for treatments.Key Contributions:★ Collected comprehensive patient histories and relevant vital signs, ensuring thorough documentation for accurate diagnosis and care planning.★ Facilitated patient education sessions, fostering understanding of cardiac health and post-procedure care.

Kernersville, Nc, Us

As a Licensed Practical Nurse, I took patient histories and recorded vital signs, providing key information that supported patient management and informed physician decision-making.Key Contribution:★ Orchestrated clinical supply inventory and ordered private vaccines, guaranteeing seamless clinic operations.

Associate'S Degree, Practical Nursing, Vocational Nursing And Nursing Assistants

Nursing, Nursing

Practical Nursing