Summary
Overview
Work History
Education
Skills
Affiliations
Timeline
Generic

GLORIA DORSETTE

Durham,NC

Summary

Efficient and proactive professional with extensive experience and proven knowledge in clinical research. Aiming to successfully provide analytical and problem-solving skills to ensure each client is handled professionally and with quality. Detail-oriented team player with strong organizational skills. Ability to handle multiple projects simultaneously with a high degree of accuracy. Organized and dependable candidate successful at managing multiple priorities with a positive attitude.

Overview

12
12
years of professional experience

Work History

Sr. Site Manager (Hemophilia and Cardiovascular)

ICON / PRA
08.2022 - 08.2023
  • Collaborated and managed Study Team. Managed sites and Sponsors by reviewing data, tracking deadlines, subject recruitment and retention, and reviewing study reports to ensure study timelines and projects are met according to company and sponsor expectations
  • Monitored and reviewed regulatory documents and regulation for US and Canadian sites and ensured sites were up to standard with all sites
  • Reviewed, evaluated and analyzed subject recruitment within studies, and partnered with sites to assist with enrollment goals along with determining potential strategies and enrollment barriers by reviewing historical metrics
  • Conducted site selection, feasibility, site pre assessment visits to determine eligibility
  • Delivered superior customer service to strengthen relationships and drive future business revenue.
  • Presented study related items to the study team and sponsors, and ensured Serious Adverse Event (SAE), CAPAs, Protocol Deviations are reported according to project specifications
  • Completed site management activities for late phase studies to ensure sponsor and investigator obligations are met and compliant with applicable local regulatory requirements and ICH guidelines
  • Assisted with conflict resolution during partnership negotiations and acquisitions.
  • Advised clients on recruitment strategies, ensuring the selection of high-performing team members to drive company success.
  • Established strong relationships with key stakeholders, fostering trust and open communication throughout the consultation process.
  • Reviewed study dashboards, metrics, compliance guidelines, created report assessment tools, questionnaires, and study site materials to be used in evaluation of study sites, and assisted with creating and completing study deliverables
  • Liaise with internal and external customers to meet project specific goals; participate in sponsor and project-related meetings and interact with client and team
  • Liaison with clinical supply / service vendors and other functional area team members to meet project team goals
  • Reviewed site and country level study documents to ensure adherence to regulatory guidelines, also provided oversight of study documents in CTMS, study protocol deviations, and study risk.
  • Maintained a deep understanding of industry trends and regulations to provide expert guidance for clients navigating complex financial environments.
  • Mentored junior team members on best practices for relationship management, contributing to overall team success.
  • Established long-lasting connections with new clientele by utilizing effective rapport-building techniques during initial interactions.
  • Managed sensitive situations diplomatically while maintaining strict confidentiality standards in handling personal client information.
  • Improved the efficiency of communication channels between clients, team members, and stakeholders by streamlining processes.

Sr. Clinical Operations Study Manager II (Oncology Breast and Colon Device and Drug Studies)

PREMIER RESEARCH (FORMERLY HEALTH DECISIONS)
02.2020 - 08.2022
  • Reviewed historical subject recruitment metrics and site feasibility questionnaires for potential sites
  • Participated in feasibility, study-start up, maintenance, close-out activities, and study documents including essential documents and informed consents (ICFs) to facilitate successful trial conduct
  • Oversaw and implemented study guidelines, GCP guidelines, ICH guidelines, study documents in CTMS, study protocol deviations, study risk, regulatory, protocol, and compliance to assure adherence to SOP guidelines
  • Coached and mentored In-House CRAs, and other junior level staff by coaching and developing them on CRO and study level task
  • Developed detailed study plans and timelines to ensure all project milestones were met within budget constraints.
  • Managed diverse study portfolios, balancing competing priorities for successful execution of multiple projects simultaneously.
  • Conducted remote monitoring tasks (queries management, site monitoring, and providing study access)
  • Handled submission and correction of regulatory document packages for site activation or IP shipment approval
  • Provided support for investigative site staff with regulatory submissions, protocol questions, and provided vendor support and communication
  • Implemented risk management strategies to proactively identify potential issues before they became critical problems during the course of studies.
  • Streamlined communication between cross-functional teams, resulting in improved collaboration and timely completion of studies.
  • Led regular status update meetings with internal teams and clients, ensuring transparency and alignment on project progress.
  • Presented and identified potential risk associated with subject's enrollment and study metrics to the Sponsors
  • Worked closely with clinical operations teams to ensure smooth implementation of study protocols at participating sites, resulting in high levels of patient enrollment and retention.
  • Established strong relationships with key stakeholders, facilitating open lines of communication and fostering a collaborative working environment.
  • Managed all aspects of study close-out, ensuring timely delivery of final reports and proper archival of essential documentation for future reference or regulatory inspection purposes.
  • Conducted thorough data analysis, providing valuable insights and recommendations for improving future studies.

In-House CRA (Oncology, Device, and Pediatric Studies) Site Management and Monitoring (Contract)

AEROTEK (Duke Clinical Research Institute DCRI)
09.2019 - 01.2020
  • Primary contact and liaison with investigative sites during study maintenance, site start-up (SSU) activities
  • Collected required investigator and regulatory documents to ensure applications were made within timelines agreed with the project management and Clinical team
  • Collected and tracked regulatory and investigator documents required for effective and compliant study site activation and maintenance
  • Updated study documents with changes in study personnel / study amendments; contributed to preparation of submissions to IRB / IEC
  • Ensured high quality site documents were filed in TMF according to study plans
  • Tracked and entered documents into CTMS and eTMF.

Data Management (Oncology Studies, Dermatology, Migraine, Pediatric cancer) (Contract)

SYNTERACT
07.2018 - 09.2019
  • Clinical data coordinator lead for clinical studies conducted within the data management
  • Reviewed site and study data and ensured sites followed study protocol guidelines
  • Maintained adherence across multiple studies to ensure studies were maintained according to SOP's and studies protocol
  • Evaluated and analyzed source documentation for case report form completion
  • Utilized multiple data capture / retrieval systems (Rave, Medrio, Azure and Datatrak) and interacted with a variety of health care delivery systems to identify such as Epic
  • Entered overdue data and query notifications in the data system to ensure timely completion
  • This allowed sites to understand and adhere to data entry guidelines.

Lead Clinical Research Regulatory Administrator, Cardiovascular and Neurological studies (Device and Drug Studies) Patient Access Specialist

NOVANT HEALTH FORSYTH MEDICAL CENTER
12.2011 - 12.2018
  • Processed documents for compliance with FDA and sponsors
  • Directly oversaw all regulatory processes and procedures for the site
  • Ensured site regulatory documents adhered to standards implemented by Sponsor, IRB, GCH and ICH guidelines
  • Tracked, monitored and submitted documents to both local and central IRB for study approval
  • Monitored trials at the site level and conducted close out visits
  • Organized workflow and delegated tasks effectively to ensure timely project completion without compromising quality.
  • Created relationships with providers, staff, and patients that allowed an environment that aligned with company policies and values, including open communication, teamwork, community support, and compassion
  • Conducted meetings and training for staff and Investigators associated with protocols and amendments with clinical studies
  • Conducted patient recruitment for studies, by reviewing patient charts in the EMR system and providing the potential list to Study Coordinators.
  • Handled sensitive information discreetly, maintaining strict confidentiality at all times as required by company policy or legal regulations.
  • Maintained personnel records and updated internal databases to support document management.

Study Start Up Specialist (Oncology and Cardiovascular) (Contract Position)

SYNEOS HEALTH
07.2017 - 07.2018
  • As study lead over global and country level studies submitted documents to both local and central IRB, along with IRB approvals for phase 2-4 studies
  • Reviewed site level and study level Informed Consent Form (ICF), along with study materials including patient materials, advertisement materials, and study level approved documents
  • Distributed start-up packets and essential documents to start up sites along with any other maintenance related documents
  • Assisted with site activation and maintaining source documents until study is moved into maintenance phase, while meeting client expectations and deliverables timelines
  • Tracked new FDA regulations and guidelines to help ensure Study Start Up and sites-maintained compliance
  • Maintained team working relationship with Principal Investigators, co-workers and sponsors to ensure all trials follow FDA and IRB guidelines
  • Communicated with site contract specialists to ensure operations were working within the site and sponsor budget.
  • Secured investor funding through persuasive pitch presentations and detailed financial analysis
  • Managed complex projects from inception to completion, ensuring timely delivery within budget constraints while maintaining high-quality standards.
  • Increased start-up efficiency by streamlining processes and implementing organizational systems.
  • Followed informed consent processes and maintained records.

Regulatory Associate / Regulatory Assistant (Contract) Breast and GOG studies (Oncology), Lineberger Comprehensive Cancer Center (Contract Position)

UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL (Piper Companies)
01.2017 - 07.2017
  • Maintained team working relationship with Principal Investigators, co-workers and sponsors to ensure all trials follow FDA and IRB guidelines, while conducting grant funded Principal Investigator initiated clinical trials
  • Created CAPA's for studies that have undergone audits, by determining root cause analysis within clinical studies
  • Ensured site regulatory documents adhered to standards implemented by Sponsor, IRB, GCH and ICH guidelines, including but not limited to regulatory binder, study documents, and staff training
  • Assisted with implementing new policies and procedures to ensure data was tracked correctly as well as implementing new programs to monitor studies, assist with physicians with patient facing materials and programs
  • Assisted with creating Standard Operating Procedures and Policies (SOP's) for the protocol office
  • Prepared IND (Investigational New Drug) and NDA (New Drug Applications) submissions for investigator initiated clinical trials.
  • Enhanced regulatory compliance by developing and implementing detailed policies and procedures.
  • Developed strong relationships with regulatory authorities, facilitating effective communication channels.
  • Collaborated with cross-functional teams to ensure timely submission of high-quality regulatory documents.
  • Improved regulatory inspection readiness by conducting internal audits and addressing identified gaps.

Education

Master of Science - Human Development and Family Studies

North Carolina Central University
Durham, NC

Bachelor of Science - Biology

North Carolina Central University
Durham, NC

Bachelor of Science - Exercise Sport Science – Minor: Chemistry

North Carolina Central University
Durham, NC

Skills

  • Risk Mitigation

  • Establishing Timelines

  • Working Cross-Functional

  • Developing Recruitment Programs

  • Stakeholder Communication

  • Multitasking and Organization

  • Team Leadership

  • Relationship Building

  • Site Management

  • Conflict Resolution

  • Data Analysis

  • Documentation Management

  • Regulatory Compliance

  • Analytical and Critical Thinking

Affiliations

  • Salvation Army Boys and Girls Club of Durham Science Club, 07/01/99, Present
  • Xi Chi Rho Social Service Fellowship Community Service Organization, 11/01/01, Present
  • Black Women in Clinical Research, 07/01/22, Present

Timeline

Sr. Site Manager (Hemophilia and Cardiovascular)

ICON / PRA
08.2022 - 08.2023

Sr. Clinical Operations Study Manager II (Oncology Breast and Colon Device and Drug Studies)

PREMIER RESEARCH (FORMERLY HEALTH DECISIONS)
02.2020 - 08.2022

In-House CRA (Oncology, Device, and Pediatric Studies) Site Management and Monitoring (Contract)

AEROTEK (Duke Clinical Research Institute DCRI)
09.2019 - 01.2020

Data Management (Oncology Studies, Dermatology, Migraine, Pediatric cancer) (Contract)

SYNTERACT
07.2018 - 09.2019

Study Start Up Specialist (Oncology and Cardiovascular) (Contract Position)

SYNEOS HEALTH
07.2017 - 07.2018

Regulatory Associate / Regulatory Assistant (Contract) Breast and GOG studies (Oncology), Lineberger Comprehensive Cancer Center (Contract Position)

UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL (Piper Companies)
01.2017 - 07.2017

Lead Clinical Research Regulatory Administrator, Cardiovascular and Neurological studies (Device and Drug Studies) Patient Access Specialist

NOVANT HEALTH FORSYTH MEDICAL CENTER
12.2011 - 12.2018

Master of Science - Human Development and Family Studies

North Carolina Central University

Bachelor of Science - Biology

North Carolina Central University

Bachelor of Science - Exercise Sport Science – Minor: Chemistry

North Carolina Central University

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GLORIA DORSETTE