Allison Cullen
Overview
5
5
years of professional experience
1
1
Certification
Work History
Clinical Research Coordinator
Children's Hospital Of Philadelphia
09.2021 - Current
- Participates in research activities which include: subject recruitment, confirmation of subject eligibility, informed consent process, completion of case report forms, data clarification, IRB preparations, chart abstraction, hosting monitor visits, hosting site initiation visits
- Responsible for assuring compliance with protocol and regulatory requirements, collecting, recording and maintaining data and source documentation, coordinate subjects, research teams, IRBs and sponsors
- Promote good clinical practices by possessing an in-depth knowledge of federal regulations and guidance documents for the conduct of clinical trials and human subject protection
- Initiates and maintains communication with the principal investigator(s) and sponsor(s) on the status of active projects, patient care issues and protocol performance
Research Assistant II
Children's Hospital Of Philadelphia
12.2020 - 09.2021
- Provided assistance and support for Neuromuscular Junction Team daily work processes
- Assisted with data management including answering queries, data entry, data validation, resolving outstanding action items
- Updated regulatory binder and provided regulatory information to both the CRO, sponsors and IRB
- Participated in Sponsor Audit conduction and close-out meetings
- Participated in meeting between CHOP PI and Sponsor after audit concluded to verify outstanding information, discuss drug accountability and help develop CAPA
- Assist CRSO Management Team through participation of QI project: Monitor Report Review
Sub-Coordinator/eDiary Specialist
Tallahassee Neurological Clinic
08.2018 - 11.2020
- Assisted medical professionals conduct ongoing clinical trials involving neurological conditions by seeing study participants at each required visit, collecting vital signs, performing ECG(s), effectively communicating with study staff involved in any given research project, and completing other administrative responsibilities - Demonstrated proficiencies in many aspects of research, especially those requiring, technical precision, meticulous data collection, recording and transmission, and patience
- Attended and engaged in Investigator Meetings and additional conferences related to ongoing clinical trials which the protocol(s), study assessments, and other pertinent information was discussed
- Completed trainings and certifications in numerous areas relating to Good Clinical Practice, HIPPA regulations, and study specific trainings
Research Assistant
Tallahassee Neurological Clinic
02.2018 - 08.2018
- Work with numerous medical professionals on a wide array of tasks including but not limited to: assisting to conduct study visits for clinical trials pertaining to different neurological conditions, adhere to study specific procedures, collect vital signs, query management, and assist physicians, nurses and faculty with administrative responsibilities
Education
Master of Science - Clinical Research Management, Organization, Administration
Drexel University
Philadelphia, PA05.2024
Bachelor of Science - Interdisciplinary Medical Science: Clinical Professions
Florida State University
Tallahassee, FL05.2020
Skills
- Clinical Trials and Research
- Good Clinical Practice GCP)
- Trial Management & Oversight
- Informed Consent
- Electronic Data Capture (EDC)
- Medidata Rave
- Clinical Data Management
- Regulatory Compliance & Submissions
- Microsoft Word
- Microsoft Excel
Certification
- Basic Life Support for Healthcare Providers (BLS), American Heart Association
- Good Clinical Practice, CITI Program
- Medidata Rave Certified Professional, Medidata Solutions
Timeline
Clinical Research Coordinator
Children's Hospital Of Philadelphia
09.2021 - Current
Research Assistant II
Children's Hospital Of Philadelphia
12.2020 - 09.2021
Sub-Coordinator/eDiary Specialist
Tallahassee Neurological Clinic
08.2018 - 11.2020
Research Assistant
Tallahassee Neurological Clinic
02.2018 - 08.2018
Master of Science - Clinical Research Management, Organization, Administration
Drexel University
Bachelor of Science - Interdisciplinary Medical Science: Clinical Professions
Florida State University