Transition from Clinical Research Manager/Study Coordinator to Clinical Research Associate. Multi-talented and detail-oriented clinical research professional with experience in diverse healthcare settings. Proven ability to assess patient’s needs and collaborate with multidisciplinary teams. Able to guide others and maintain a positive group dynamic through issue resolution skills. Experienced in data management and compliance protocols. Seeking to leverage my expertise to contribute to the successful execution of clinical trials. Aspiring to pursue a career as a clinical research associate.
Overview
11
11
years of professional experience
Work History
Clinical Research Manager/Study Coordinator
Atlanta Gastroenterology
04.2024 - Current
Ensure all clinical trials are conducted in compliance with Good Clinical Practice (GCP), FDA regulations, and ICH guidelines
Ensure that study protocols are reviewed and approved by Institutional Review Boards or Ethics Committees
Collaborate with investigators, medical experts, and other stakeholders to define study objectives, methodology, and timelines
Coordinated participant recruitment, screening, and enrollment for clinical trials
Collected and managed clinical data in accordance with trial protocols and regulatory guidelines
Served as primary contact for study participants, providing ongoing communication and support throughout study lifecycle
Managed study documentation, ensuring accurate data entry and adherence to study protocols
Assisted with trial closeout activities, including data reconciliation and report generation.
Clinical Research Nurse
Prince George’s Hospital Center
05.2013 - 03.2014
Collect clinical data, including lab results, patient-reported outcomes, and medical histories, ensuring accuracy and completeness
Provide clear communication to patients regarding procedures, any changes in their care, and potential impacts of study interventions
Administer Investigational Product (IP) or devices to participants as specified in protocol, often under blind or double-blind conditions
Manage accountability, storage, and documentation of study drugs or devices, ensuring proper handling and record-keeping
Facilitate transition of patient care back to their primary healthcare provider after trial ends
Collaborate with physicians, research coordinators, pharmacists, data managers, and other healthcare professionals to ensure safe operations of clinical trial
Supported clinical trials team in maintaining accurate and up-to-date study documentation
Coordinated logistics for clinical trial meetings, including investigator meetings and study team calls
Participated in development of study-related materials, such as informed consent forms and case report forms
Assisted in resolving data discrepancies and ensuring data integrity.
Education
Bachelor of Science in Health Sciences -
Old Dominion University
Norfolk, VA
Bachelor of Science in Nursing - undefined
Marymount University
Arlington, VA
Skills
Clinical Trial Monitoring
Regulatory Compliance (ICH-GCP, FDA)
Data Management
Trial Master File (TMF) Management
Investigational Product (IP) Accountability
IRB Submissions
Participant Recruitment and Coordination
Strong Communication and Collaboration
Attention to Detail and Problem-Solving Skills
Microsoft Office Suite (Word, Excel, PowerPoint)
EDC Systems (eg, Medidata, Oracle Clinical)
Clinical Trial Management Systems (CTMS)
Regulatory Document Systems
Certifications & Training
Good Clinical Practice (GCP) Certification – 2013 – Current